[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-neoplasms":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,146,0,25,[9,42,67,95,129,151,176,196,218,247,289,315,346,370,399,426,455,486,517,553,594,613,636,658,680],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100615015","phase-2-a-study-of-imlunestrant-ly3484356-in-premenopausal-women-with-estrogen-receptor-positive-er-human-epidermal-growth-factor-receptor-2-negative-her2--early-breast-cancer-100615015",false,"NCT07287098","A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer","preEMBER: A Phase 2, Open-label Study Evaluating Imlunestrant in Premenopausal Women With Estrogen Receptor-Positive, HER2-Negative Breast Cancer","preEMBER","Inclusion Criteria:\n\nCohort 1:\n\n* Have histologically confirmed Stage I to III Estrogen Receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) invasive breast carcinoma with Ki-67 at least 10%\n* Be willing and able to provide pre- and on-treatment tumor samples.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Be able to swallow capsules or tablets.\n* Be premenopausal women.\n* If of childbearing potential must use 1 highly effective method of non-hormonal contraception while receiving study treatment and for the duration specified in protocol.\n* Have adequate organ function.\n\nCohort 2:\n\n* Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis\n* Have undergone definitive loco-regional therapy.\n* Have received at least 4.5 years of any adjuvant endocrine therapy (ET), or at least 2 years of adjuvant ET with no additional ovarian suppression planned.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Be able to swallow capsules or tablets.\n* Be premenopausal women\n* If of childbearing potential must use 1 highly effective method of non-hormonal contraception while receiving study treatment and for the duration specified in protocol.\n* Have adequate organ function.\n\nExclusion Criteria:\n\nCohort 1:\n\n* Have bilateral invasive metastatic, occult primary, or inflammatory breast cancer.\n* Have had prior bilateral oophorectomy or ovarian ablation.\n* Have a serious medical condition\n* Had major surgery within 28 days prior to randomization.\n* Have a history of other cancer (except non melanoma skin cancer, Stage I uterine cancer, or carcinoma in situ of the cervix or other in situ cancer), unless in complete remission with no therapy for a minimum of 1 year.\n* Plan to receive concurrent neoadjuvant therapy with any other non-protocol anticancer therapy.\n* Have had any prior therapy for an invasive or non-invasive breast cancer.\n* Have had prior radiotherapy to the ipsilateral chest wall for any malignancy.\n* Have received prior anti-estrogen therapy, including for osteoporosis or prevention of breast cancer.\n* Have had prior treatment with any Gonadotropin-releasing hormone (GnRH) agonist within 12 months prior to randomization.\n* Receiving current exogenous reproductive hormone therapy\n\nCohort 2:\n\n* Have ovarian cyst(s) greater than (\\>) 1 centimeter (cm) at screening.\n* Have metastatic occult primary, or inflammatory breast cancer.\n* Have had prior bilateral oophorectomy or ovarian ablation.\n* Have a serious medical condition\n* Had major surgery within 28 days prior to randomization.\n* Have a history of other cancer (except non melanoma skin cancer or carcinoma in situ of the cervix or other in situ cancer), unless in complete remission with no therapy for a minimum of 1 year.\n* Completed or discontinued prior adjuvant ET \\>6 months prior to screening.\n* Have received prior therapy with any selective estrogen receptor degrader (SERD).\n* Receiving current exogenous reproductive hormone therapy.","FEMALE","18 Years",{"count":21,"type":22},600,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This study will include two groups of patients: Cohort 1 and Cohort 2.\n\nCohort 1: will help researchers learn how a medicine called imlunestrant (LY3484356) affects a specific type of breast cancer. Some patients will take both imlunestrant and another treatment to suppress their ovarian function. Some will take it without ovarian suppression. Researchers will compare the effects in breast cancer cells to those of another medicine called tamoxifen. All patients in this group will be premenopausal women who have a type of early breast cancer called estrogen receptor-positive, HER2-negative. The treatment in this group will last for up to 29 days.\n\nCohort 2: will help researchers understand how imlunestrant affects the ovaries when it is taken without ovarian suppression. Researchers will compare the effects to those of another medicine called tamoxifen. This group will also include premenopausal women with the same type of breast cancer. The treatment in this group will last for up to 6 months.",[28],"Breast Neoplasms","RECRUITING","2026-08-20",{"date":32,"type":33},"2026-08-21","ACTUAL",{"date":35,"type":33},"2026-05-13",{"date":37,"type":22},"2029-12",{"name":39,"class":40},"Eli Lilly and Company","INDUSTRY",89,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":49,"minAge":19,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100606344","phase-3-a-study-of-tersolisib-ly4064809stx-478-with-other-anti-cancer-treatments-in-participants-with-advanced-breast-cancer-with-a-genetic-change-pik3ca-100606344","NCT07174336","A Study of Tersolisib (LY4064809\u002FSTX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)","A Phase 2, Randomized, Open-Label Dose Optimization and Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4\u002F6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)","Inclusion Criteria:\n\n* Are willing to follow contraception requirements. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials.\n* If assigned female at birth, pre-\u002Fperi- and postmenopausal status is allowed. Those with pre- or peri-menopausal status at study entry must agree to use ovarian function suppression with any locally approved gonadotropin-releasing hormone (GnRH) agonist.\n* If assigned male at birth with an estrogen receptor positive (ER+) breast cancer diagnosis, they must agree to use hormone suppression with a GnRH agonist.\n* Have histologically or cytologically confirmed breast cancer, defined as individuals with\n\n  * locally advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease, and\n  * hormone receptors (HR)+\u002Fhuman epidermal growth factor receptor 2 (HER2)- or HR+\u002FHER low defined by American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) Guidelines\n\n    * HR status: Documented ER+ and\u002For progesterone receptor-positive (PR+) tumor according to ASCO\u002FCAP Guidelines, defined as greater than or equal to (≥)1 percent (%) of tumor cells stained positive based on the most recent tumor biopsy and assessed locally\n    * HER status: immunohistochemistry score of 1+ or score of 2+ with a negative Fluorescence In Situ Hybridization (FISH) based on local results as defined in the ASCO\u002FCAP Guidelines\n* Have evidence of an activating PIK3CA mutation, detected in tumor or blood samples using an appropriate assay.\n* Have measurable disease or non-measurable, evaluable bone disease\n* Part 1:\n\n  * Received 0-2 prior systemic treatments for advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease.\n  * Up to 1 of these prior systemic treatments may contain chemotherapy\n* Part 2:\n\n  * Received 0 prior systemic treatment for advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease.\n  * Individuals who are eligible are either\n\n    * Population 1 (P1): Endocrine sensitive\n\n      * newly diagnosed with advanced breast cancer (de novo)\n      * participants with a history of HR+, HER2- EBC and did not receive SOC adjuvant ET\n      * relapsed with documented evidence of progression greater than (\\>)12 months from completion of (neo)adjuvant ET ± cyclin-dependent kinases 4 and 6 (CDK4\u002F6) inhibitor, or\n    * Population 2 (P2): Endocrine resistant\n\n      * relapsed with documented evidence of progression less than or equal to (≤)12 months of completing (neo)adjuvant ET ± CDK4\u002F6 inhibitor.\n      * if a CDK4\u002F6 inhibitor was included as part of neoadjuvant or adjuvant therapy, progression event must be \\>12 months since completion of CDK4\u002F6 inhibitor portion of neoadjuvant or adjuvant therapy.\n\nExclusion Criteria:\n\n* Have an established diagnosis of Type 1 diabetes mellitus or Type 2 diabetes mellitus with hemoglobin A1c (HbA1c) ≥8%, fasting blood glucose (FBG) ≥140 milligrams per deciliter (mg\u002FdL) (7.7 millimoles per liter \\[mmol\u002FL\\]), or requiring insulin.\n* Have inflammatory or metaplastic breast cancer.\n* History of leptomeningeal disease or carcinomatous meningitis.\n* Have known and untreated or active central nervous system (CNS) metastases. Exception: Asymptomatic brain or spinal metastases if treated by surgery, surgery plus radiotherapy, or radiotherapy alone with no evidence of radiographic progression or hemorrhage within at least 28 days before randomization and no requirement for anticonvulsants or systemic corticosteroids for at least 28 days before randomization.\n* Have received treatment with any local or systemic antineoplastic therapy or investigational anticancer agent within 14 days or 4 half-lives, whichever is longer, prior to randomization up to a maximum washout period of 28 days.\n* Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dose more than 10 milligrams \\[mg\\] daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization.\n* Are pregnant, breastfeeding, or intend to become pregnant during the study or within 6 months of the last dose of study intervention and at least 2 years after the last dose of fulvestrant and\u002For CDK4\u002F6 inhibitor after the final administration of study treatment.\n* Have active bacterial or fungal infection that is not recovered at randomization.","ALL",{"count":51,"type":22},800,[53],"PHASE3","The purpose of the study is to assess the efficacy and safety of the addition of Tersolisib (LY4064809\u002FSTX-478) to other anti-cancer drugs as first treatment for advanced hormone receptor-positive (HR+)\u002Fhuman epidermal growth factor receptor 2-negative (HER2-) breast cancer. Participants can remain in the study as long as the drug is helping the cancer without unbearable side effects.",[28,56],"Neoplasm Metastasis",[58,59],"STX-478","PI3K",{"date":32,"type":33},{"date":62,"type":33},"2025-12-22",{"date":64,"type":22},"2033-05",{"name":39,"class":40},359,{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":12,"sex":49,"minAge":19,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":23,"phases":77,"briefSummary":79,"conditions":80,"keywords":86,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":88,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},"100601754","phase-1-a-study-of-ly4257496-in-participants-with-cancer-omniray-100601754","NCT07114601","A Study of LY4257496 in Participants With Cancer (OMNIRAY)","A Phase 1a\u002Fb Multicenter, Open-Label Trial to Evaluate Safety, Tolerability, and Dosimetry of LY4257496, a GRPR-Targeted Radioligand Therapy, in Adults With GRPR-Positive Advanced Solid Tumors (OMNIRAY)","OMNIRAY","Inclusion Criteria:\n\n* Must have histologically or cytologically proven diagnosis of locally advanced, unresectable, or metastatic cancer.\n* Must be assessed by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI) to confirm at least 1 of the following:\n\n  * At least 1 measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n  * If only bone lesions are present without a soft-tissue component, a bone scan or MRI must confirm at least 2 detectable lesions considered to represent active metastases\n* Must have GRPR-positive disease, defined by investigator assessment of GRPR imaging.\n* Must have the following histologically or cytologically confirmed diagnosis:\n\n  * Estrogen receptor (ER+)\u002Fhuman epidermal growth factor receptor 2 (HER2-) breast cancer\n  * ER+\u002FHER2+ breast cancer\n  * Esophageal squamous cell carcinoma\n  * Adenocarcinoma of the stomach, gastroesophageal junction, or esophagus\n  * Colorectal carcinoma\n  * Metastatic castration-resistant prostate cancer\n  * Endometrial carcinoma. Carcinosarcoma is eligible. Uterine leiomyosarcoma, adenosarcoma, or endometrial stromal sarcoma is not eligible.\n  * Low-grade papillary serous ovarian cancer\n  * Other non-Central Nervous System (CNS) primary GRPR-positive solid tumors (Cohorts A1 dose escalation and D1 dose expansion only)\n* For participants with breast cancer diagnosis, where possible, ER and HER2 status should be assessed from the most recent tissue biopsy taken at the time of presentation with recurrent or metastatic disease.\n\n  * To fulfill the requirement for ER+ disease by local testing, a tumor must express the ER immunohistochemistry, as defined in the relevant American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines.\n  * HER2 status should be determined by local testing, as defined in the relevant ASCO\u002FCAP Guidelines.\n* Must have an Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1.\n* Must be able to comply with outpatient treatment, laboratory monitoring, imaging, and required clinic visits for the duration of trial participation.\n\nExclusion Criteria:\n\n* Phase 1a (Cohort A1 and A2) only: Previously received radiopharmaceutical or radioligand therapy. For participants with prostate cancer, prior ¹⁷⁷Lu-prostate-specific membrane antigen (PSMA) is permitted.\n* Has a history of ongoing acute pancreatitis within 1 year of screening.\n* Previously received any prior hemi-body or whole-body radiotherapy, or prior external beam radiation therapy (EBRT) to greater than 25% of the bone marrow.\n* A bone superscan, defined as a bone scan that demonstrates markedly increased skeletal radioisotope uptake relative to soft tissues in association with absent or faint genitourinary tract activity.\n* Has evidence of ongoing and untreated urinary tract obstruction or unmanageable urinary incontinence.\n* Have known active hepatitis B virus (HBV). Exception: Individuals with chronic HBV if they:\n\n  * Have positive HBsAg\n  * Are on suppressive antiviral therapy, as allowed per local regulations prior to C1D1\n  * Remain on the same antiviral treatment throughout study, and should follow local standards for continuation of therapy after completion of trial therapy.\n  * Have undetectable HBV DNA ≤14 days of C1D1.\n* Have known active hepatitis C virus (HCV). Exception: Individuals previously treated for HCV if they:\n\n  * Completed curative antiviral therapy.\n  * Have an HCV viral load below the limit of quantification ≤14 days of C1D1 and.\n  * Are positive for anti-HCV antibodies and negative for HCV ribonucleic acid (RNA) before randomization.\n* Have untreated human immunodeficiency virus (HIV) infection. Exception: Individuals who have well-controlled HIV infection\u002Fdisease and they:\n\n  * Are on a stable and permitted antiretroviral therapy (ART) regimen without changes in drug or dose, for at least 4 weeks prior to C1D1\n  * Have a viral load of \\\u003C400 copies\u002FmL ≤14 days of C1D1.\n  * Have a CD4+ T-cell count ≥350 cells\u002FmL ≤14 days of C1D1.\n  * Have not had an opportunistic infection within the past 12 months.\n* Has an active second malignancy unless in remission with life expectancy greater than 2 years.\n* Has known hypersensitivity to any component or excipient of LY4257496.",{"count":76,"type":22},421,[78],"PHASE1","The main purpose of this study is to evaluate safety, tolerability, and efficacy of LY4257496 alone and as part of relevant standard of care (SOC) combination therapy in participants with Gastrin-releasing Peptide Receptor (GRPR)-positive advanced cancer, including but not limited to breast, colorectal, prostate, endometrial, esophageal, gastroesophageal (GE) junction, and gastric cancer. The study will also evaluate the safety, tolerability, and efficacy of LY4257529 to identify cancer with high levels of a protein called GRPR. This is a 2-part study. Participation could last up to 36 weeks or until your tumor progresses.",[28,81,82,83,56,84,85],"Colorectal Neoplasms","Prostate Neoplasm","Endometrial Neoplasms","Stomach Neoplasms","Esophageal Neoplasms",[87],"GRPR-positive",{"date":32,"type":33},{"date":90,"type":33},"2025-08-06",{"date":92,"type":22},"2035-04",{"name":39,"class":40},32,{"id":96,"slug":97,"hasResults":12,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":102,"sex":18,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":4,"studyType":23,"phases":107,"briefSummary":109,"conditions":110,"keywords":114,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":128},"100524209","biennial-cem-in-women-with-a-personal-history-of-breast-cancer-100524209","NCT06105749","Biennial CEM in Women With a Personal History of Breast Cancer","Outcome of Biennial Screening Contrast-Enhanced Mammography (CEM) in Women With a Personal History of Breast Cancer (PHBC)","Inclusion Criteria:\n\n* Asymptomatic women, ages 30-79, with a personal history of breast cancer who are at least one year out from any breast cancer surgery and\u002For treatment and are scheduled to have a routine annual mammogram with tomosynthesis (DBT).\n\nExclusion Criteria:\n\n* Women with a history of prior moderate or severe iodinated contrast reaction \\[only those with a prior mild reaction that can be managed by pre-medication AND with and a strong desire to participate will be allowed to participate. However, among these women with a mild sensitivity, if they are allergic to Benadryl (one of the premedications), they will be excluded\\].\n* Women with implant(s) in the breasts to be screened (as this creates artifacts and diagnostic performance of imaging in women with implants likely does not generalize to those without implants, and the sample size with implants would be too small to infer conclusions.\n* Women who have had bilateral mastectomy\n* Women with a history of kidney failure or estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\n* Pregnancy or lactation\n* Women actively being treated for cancer of any type with chemotherapy.\n* Women with stage 4 metastasis to visceral areas or brain\n* Women with known personal history of breast cancer who have a screening breast MRI exam within 24 months prior to the current round of CEM.\n* Women with known personal history of breast cancer who had a CEM exam within the prior 23 months",true,"30 Years","79 Years",{"count":106,"type":22},1600,[108],"NA","This is a prospective clinical trial that will examine if biennial contrast-enhanced mammography added to annual 3D mammography (tomosynthesis) substantially improves breast cancer detection with minimal increase in false-positives, in women with a personal history of breast cancer.",[111,28,112,113],"Breast Cancer","Breast Cancer Female","Neoplasms",[115,116,117],"Breast cancer screening","Digital Breast Tomosynthesis","Contrast-Enhanced Mammogram","2026-08-17",{"date":120,"type":33},"2026-08-19",{"date":122,"type":33},"2023-11-08",{"date":124,"type":22},"2031-04",{"name":126,"class":127},"Wendie Berg","OTHER",6,{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":49,"minAge":19,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":23,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":150},"100597616","phase-3-a-clinical-study-of-patritumab-deruxtecan-to-treat-breast-cancer-mk-1022-016-100597616","NCT07060807","A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)","An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy Versus Treatment of Physician's Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04).","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a diagnosis of hormone receptor positive (HR+)\u002Fhuman epidermal growth factor receptor 2 (HER2)- invasive breast carcinoma that is either locally advanced disease not amenable to resection with curative intent (herein called unresectable) or metastatic disease not treatable with curative intent\n* Has centrally-confirmed HR+ and HER2- results and human epidermal growth factor receptor 3 (HER3) evaluable results from a biopsy obtained from a distant metastatic site or a locally advanced lesion on or after the most recent line of therapy (with certain exceptions)\n* Must have had progression or recurrence on prior cyclin-dependent kinase (CDK)4\u002F6 inhibitor + endocrine therapy (ET) with one of the following:\n\n  * Radiographic disease progression, as assessed by the investigator, on CDK4\u002F6 inhibitor + ET as 1L for treatment of unresectable locally advanced or metastatic HR+\u002FHER2- breast cancer. CDK4\u002F6 inhibitor + ET must be the only line of therapy received in the advanced setting, or\n  * Disease recurrence, either radiographic and\u002For confirmed histologically via biopsy as assessed by the investigator, while on adjuvant ET in combination with a CDK4\u002F6 inhibitor OR within 24 months from the date of last dose of adjuvant CDK4\u002F6 inhibitor\n* Has measurable disease per RECIST 1.1 as assessed by the local site investigator\u002Fradiology\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy\n* Has an Eastern Cooperative Oncology Group performance status of 0 or 1 assessed within 7 days before randomization\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has breast cancer amenable to treatment with curative intent\n* Is eligible to receive additional endocrine-based treatment in the advanced setting as determined by the investigator\n* Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) where poly (ADP-ribose) polymerase (PARP) inhibitor(s) is a potential treatment option\n* Has current visceral crisis or is at risk for impending visceral crisis that has or may cause imminent organ compromise and\u002For other life-threatening complications\n* Has any of the following: a pulse oximeter reading \\\u003C92% at rest, or requires intermittent supplemental oxygen, or requires chronic supplemental oxygen\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Has ≥Grade 2 peripheral neuropathy.\n* Has clinically significant corneal disease\n* Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer\n* Has received prior treatment with an anti-HER3 antibody and\u002For antibody-drug conjugate that consists of a topoisomerase I inhibitor (eg, T-DXd) or any other topoisomerase I inhibitor therapy\n* Has received prior systemic anticancer therapy within 4 weeks (or 5 half-lives, whichever is shorter) before randomization; participants previously treated with ET plus a CDK4\u002F6 inhibitor may participate as long as at least 2 weeks have elapsed since the last dose of therapy was administered\n* Has received prior radiotherapy for non-central nervous system disease, or required corticosteroids for radiation-related toxicities, within 14 days of the first dose of study intervention\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has history of (noninfectious) pneumonitis\u002Finterstitial lung disease (ILD) that required steroids, has current pneumonitis\u002Finterstitial lung disease, or has suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at Screening\n* Has severe hypersensitivity (≥Grade 3) to HER3-DXd and\u002For any of its excipients\n* Has severe hypersensitivity (≥Grade 3) to all the available TPC and\u002For any of their excipients",{"count":137,"type":22},1000,[53],"Researchers are looking for other ways to treat breast cancer (BC) that is hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+\u002FHER2-) and either unresectable locally advanced or metastatic.\n\n* HR positive (HR+) means the cancer cells have proteins that attach to estrogen or progesterone (hormones) which help the cancer to grow and spread\n* HER2 negative (HER2-) means the cancer cells have a low amount of a protein called HER2\n* Unresectable locally advanced means the cancer cannot be completely removed by surgery and has spread into nearby tissue or muscles\n* Metastatic means the cancer has spread to other parts of the body\n\nTreatment for this type of breast cancer usually includes endocrine therapy (ET) and sometimes a second treatment. The main goal of this study is to learn if people who receive patritumab deruxtecan (also known as HER3-DXd and MK-1022) live longer overall or without the cancer growing\u002Fspreading, compared to people who receive chemotherapy or a different drug called trastuzumab deruxtecan.",[28],"2026-08-13",{"date":143,"type":33},"2026-08-14",{"date":145,"type":33},"2025-07-21",{"date":147,"type":22},"2033-07-14",{"name":149,"class":40},"Merck Sharp & Dohme LLC",198,{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":12,"sex":49,"minAge":19,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":23,"phases":160,"briefSummary":161,"conditions":162,"keywords":165,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":169,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},"100590383","phase-3-a-clinical-study-of-sacituzumab-tirumotecan-sac-tmt-mk-2870-in-people-with-breast-cancer-mk-2870-032-100590383","NCT06966700","A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)","A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin\u002FPaclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive\u002FHuman Epidermal Growth Factor Receptor-2 Negative Breast Cancer","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per AJCC 8th edition criteria as assessed by the physician investigator based on radiological and\u002For clinical assessment:\n\n  * cT1c, N1-N2\n  * cT2, N0-N2\n  * cT3, N0-N2\n  * cT4a-d, N0-N2\n* The participant must have a centrally confirmed diagnosis of BC that is triple-negative or HR-low+\u002FHER2- (defined as estrogen receptor (ER)-low+ expression in 1% to 10% cells and HER2- as by the most recent American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines.\n* Provides a core needle biopsy from the primary breast tumor at screening to the central laboratory.\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 28 days before Cycle1 Day 1 (C1D1).\n* Demonstrates adequate organ function.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Metastatic (Stage IV) breast cancer or clinical node stage 3 (cN3) nodal involvement\n* Has received any prior treatment, including radiation, systemic therapy,and\u002For definitive surgery for currently diagnosed breast cancer\n* Has undergone excisional biopsy of the primary tumor, axillary lymph node dissection, and\u002For axillary sentinel lymph node biopsy prior to study treatment.\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before C1D1.\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX- 40, CD137).\n* Received prior treatment with a TROP2-targeted antibody-drug conjugate (ADC).\n* Received prior treatment with a topoisomerase I inhibitor-containing ADC.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.\n* Known additional malignancy that is progressing or has required active treatment within the past 5 years.\n* Uncontrolled systemic disease.\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids, has current pneumonitis\u002Finterstitial lung disease or has suspected interstitial lung disease (ILD) or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening..",{"count":159,"type":22},2400,[53],"Researchers are looking for new ways to treat types of breast cancer that are both:\n\n* High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment\n* Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive\u002Fhuman epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone.\n\nSacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread.\n\nThe main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy:\n\n* Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy\n* Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy",[28,163,164],"Triple Negative Breast Neoplasms","HR Low-Positive\u002FHER2-Negative Breast Neoplasms",[166,167,168],"Programmed Cell Death-1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)",{"date":143,"type":33},{"date":171,"type":33},"2025-06-30",{"date":173,"type":22},"2034-12-29",{"name":149,"class":40},319,{"id":177,"slug":178,"hasResults":12,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":12,"sex":49,"minAge":19,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":23,"phases":185,"briefSummary":186,"conditions":187,"keywords":188,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":189,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":195},"100540079","phase-3-a-study-of-sacituzumab-tirumotecan-mk-2870-as-a-single-agent-and-in-combination-with-pembrolizumab-mk-3475-versus-treatment-of-physicians-choice-in-participants-with-hrher2--unresectable-locally-advanced-or-metastatic-breast-cancer-mk-2870-010-100540079","NCT06312176","A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+\u002FHER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)","An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With HR+\u002FHER2- Unresectable Locally Advanced or Metastatic Breast Cancer","Inclusion Criteria:\n\n* Has unresectable locally advanced or metastatic centrally-confirmed hormone receptor positive (HR+)\u002Fhuman epidermal growth factor receptor 2 negative (HER2-) breast cancer\n* Has radiographic disease progression on one or more lines of endocrine therapy for unresectable locally advanced\u002Fmetastatic HR+\u002FHER2- breast cancer, with one in combination with a CDK4\u002F6 inhibitor\n* Is a chemotherapy candidate\n* Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization\n* Has adequate organ function\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy\n* Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load\n* Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable\n\nExclusion Criteria:\n\n* Has breast cancer amenable to treatment with curative intent\n* Has experienced an early recurrence (\\\u003C6 months after completing adjuvant\u002Fneoadjuvant chemotherapy) and therefore is eligible to receive second-line (2L) treatment\n* Has symptomatic advanced\u002Fmetastatic visceral spread at risk of rapidly evolving into life-threatening complications\n* Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer\n* Active autoimmune disease that has required systemic treatment in the past 2 years\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that requires steroids, or has current pneumonitis\u002Finterstitial lung disease\n* Has an active infection requiring systemic therapy",{"count":184,"type":22},1200,[53],"The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive\u002Fhuman epidermal growth factor receptor-2 negative (HR+\u002FHER2-) unresectable locally advanced, or metastatic, breast cancer.\n\nThe primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.",[28],[166,167,168],{"date":143,"type":33},{"date":191,"type":33},"2024-04-14",{"date":193,"type":22},"2031-04-12",{"name":149,"class":40},259,{"id":197,"slug":198,"hasResults":12,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":203,"enrollmentInfo":204,"targetDuration":4,"studyType":23,"phases":206,"briefSummary":207,"conditions":208,"keywords":4,"overallStatus":209,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":4},"100651585","analysis-of-multimodal-psychosomatic-comorbidity-burden-in-breast-cancer-and-benefit-evaluation-of-acupuncture-collaborative-management-regimen-100651585","NCT07763587","Analysis of Multimodal Psychosomatic Comorbidity Burden in Breast Cancer and Benefit Evaluation of Acupuncture Collaborative Management Regimen","A Pragmatic Randomized Controlled Trial on Acupuncture Intervention to Alleviate Multifaceted Psychosomatic Comorbidities Among Breast Cancer Patients Based on Shared Decision-Making Model","Inclusion Criteria:\n\n* Female patients aged 18 to 70 years old;\n* Patients with pathologically or cytologically confirmed breast cancer;\n* Meeting at least one diagnostic criterion for psychosomatic symptoms:Anxiety or depressive state: subscale score of anxiety or depression on the HADS ≥ 8;Sleep disturbance: total score of the PSQI ≥ 8;Cancer-related fatigue: total score of the BFI ≥ 4;\n* Expected survival time ≥ 1 year;\n* Clear consciousness, basic communication ability, and capacity to complete scale assessments cooperatively;\n* Voluntary written informed consent signed by the patient or legal representative.\n\nExclusion Criteria:\n\n* Patients with severe mental disorders (such as schizophrenia and bipolar disorder) or lacking civil capacity;\n* Ineligibility for auricular point pressing intervention: local auricular skin breakage, infection, or allergic constitution (allergy to vaccaria seeds or adhesive plasters);\n* Patients receiving other acupuncture or acupoint pressing interventions, or those unable to discontinue such treatments during the trial period;\n* Patients unsuitable for manual acupuncture, including those with bleeding tendency (e.g., coagulation disorders, purpura) or local skin lesions at acupoint sites;\n* Complicated with severe heart, liver, renal or other organ failure, or cachexia;\n* Pregnant or lactating women.","70 Years",{"count":205,"type":22},216,[108],"This study adopts a multicenter, pragmatic, umbrella randomized controlled trial design integrated with the shared decision-making (SDM) model. Patients are stratified into four subgroups based on their core psychosomatic symptom phenotypes (single symptom vs. multiple comorbid symptoms). Participants are randomly assigned to the intervention group or control group at a 2:1 allocation ratio. For the intervention group, personalized interventions (including manual acupuncture, auricular point pressing, and combined manual acupuncture plus auricular point pressing) are selected via shared decision-making between clinicians and patients, while the control group receives routine nursing care. The study evaluates the improvement efficacy of single symptoms and the synergistic relief effect of multiple co-occurring symptoms across all psychosomatic phenotype subgroups under the shared decision-making framework. This design addresses the limitation of conventional randomized controlled trials that only focus on individual symptoms, and better fits real-world clinical scenarios characterized by multimorbid coexistence.",[28],"NOT_YET_RECRUITING","2026-08-12",{"date":141,"type":33},{"date":213,"type":22},"2026-08-01",{"date":215,"type":22},"2028-03-31",{"name":217,"class":127},"First Teaching Hospital of Tianjin University of Traditional Chinese Medicine",{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":102,"sex":18,"minAge":225,"maxAge":226,"enrollmentInfo":227,"targetDuration":4,"studyType":23,"phases":229,"briefSummary":230,"conditions":231,"keywords":232,"overallStatus":209,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":239,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":246},"100650503","increasing-breast-and-colorectal-cancer-screening-in-the-community-100650503","NCT07748377","Increasing Breast and Colorectal Cancer Screening in the Community","A Pilot Trial of a Community-Based Strategy to Improve Colorectal and Breast Cancer Screening","Inclusion Criteria:\n\n* Age 45-75 years old\n* Self-identify as Chinese and born outside of the U.S.\n* Speaks Mandarin, Cantonese, or English\n* Not up to date on BC screening (i.e., have not had a mammogram within the past two years)\n* Not up to date on CRC screening (i.e., have not had any of the following tests)\n\n  * Colonoscopy within the past 10 years\n  * Fecal immunochemical tests\u002Ffecal occult blood tests within the past year or multi-target stool DNA test within the past three years\n  * Flexible sigmoidoscopy within the past 5 years\n  * CT colonography within the past 5 years\n\nExclusion Criteria:\n\n* Life expectancy ≤ 10 years or other pre-existing conditions whereby CRC or BC screening would not be recommended\n* Personal history of BC or CRC\n* Prior history of a total colectomy or mastectomy\n* Lacks capacity to provide informed consent","45 Years","75 Years",{"count":228,"type":22},80,[108],"The goal of the proposed study is to conduct a pilot randomized controlled trial (RCT) of Chi gung, a community-based intervention using peer education and tailored navigation to simultaneously improve colorectal (CRC) and breast cancer (BC) screening rates.",[81,28],[233,234,235,236,237,238],"Community Engaged Research","Early Detection of Cancer","Colorectal Cancer Screening","Breast Cancer Screening","Patient Navigation","Community Health Workers",{"date":143,"type":33},{"date":241,"type":22},"2026-09",{"date":243,"type":22},"2029-03",{"name":245,"class":127},"Icahn School of Medicine at Mount Sinai",7,{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":12,"sex":49,"minAge":19,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":23,"phases":257,"briefSummary":258,"conditions":259,"keywords":262,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":288},"100609434","signatera-guided-cdk46-inhibitor-therapy-in-breast-cancer-100609434","NCT07214532","Signatera-Guided CDK4\u002F6 Inhibitor Therapy in Breast Cancer","SIgnatera-Guided Initiation of Adjuvant CDK4\u002F6 Inhibitor in Intermediate Risk HR+ HER2- Breast Cancer","SIGNAL-ER 101","Inclusion Criteria:\n\n1. Signed and dated Informed Consent Form (ICF) obtained prior to any trial-specific screening procedure.\n2. Patient is ≥ 18 years-old at the time of ICF signature.\n3. Patient is female with known menopausal status at the time of initiation of adjuvant endocrine therapy (ET), or male.\n4. Patient with histologically confirmed unilateral and unifocal primary invasive adenocarcinoma of the breast prior to initiating adjuvant chemotherapy, if indicated, or within 6 months of initiating adjuvant endocrine therapy if chemotherapy is not indicated. Patients who receive neoadjuvant endocrine therapy or chemotherapy are allowed to enroll.\n5. Patient has breast cancer that is positive for ER and\u002For PR according to the local laboratory as determined on the most recently analyzed tissue sample.\n6. Patient has HER2-negative breast cancer defined as a negative in situ hybridization test (FISH, CISH, or SISH) or an immunohistochemistry (IHC) status of 0 or 1+. If IHC is 2+, a negative in situ hybridization (ISH) test is required to confirm the HER2-negative status.\n7. Patient has available archival tumor tissue from the diagnostic biopsy or surgical specimen, for submission to a central laboratory for Signatera testing (unless Signatera Genome clinical testing has already been performed).\n8. Patient after surgical resection where tumor was removed completely (i.e., negative microscopic margins on final pathology) and have Anatomic Stage II that is eligible for adjuvant CDK4\u002F6 inhibitors. The criteria to be eligible for adjuvant CDK4\u002F6 inhibitors include N1, or N0 with T3 or T2 with either G3, or G2 with Ki67 greater or equal to 20% or high genomic risk score.\n\n   Notes:\n   1. Patients who received neoadjuvant treatment must meet the criteria for stage, grade, Ki67 in any presurgical staging\u002Fsample and\u002For in the surgical specimen.\n   2. Categorization into the AJCC 8th edition Anatomic Stage Groups requires determination of the T, N and M categories. ALND can be omitted.\n9. Patient has no contraindication to adjuvant ET and is planned to be treated with ET for 5 years (since enrollment date) or more.\n10. Provider and patient must be agreeable to initiate CDK4\u002F6 inhibitors only upon ctDNA detection.\n11. Patient may have received up to 6 months of standard adjuvant ET at the time of enrollment and any amount of neoadjuvant endocrine therapy.\n12. Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n13. Patient must not have a clinical contraindication to ribociclib or abemaciclib.\n14. Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.\n15. Women of childbearing potential (CBP) must have a confirmed negative serum pregnancy test within 14 days prior to enrollment.\n16. Women of reproductive potential should be advised of the potential risk of CDK4\u002F6 inhibitors to a fetus, and use effective contraception during CDK 4\u002F6 inhibitor therapy.\n\nExclusion Criteria:\n\n1. Patient has had prior exposure to a CDK4\u002F6 inhibitor.\n2. Patient is concurrently using hormone replacement therapy.\n3. Patient with a known contraindication or hypersensitivity to ribociclib or abemaciclib as per the FDA indication label.\n4. Patients with a multicentric and\u002For multifocal and synchronous contralateral breast cancer are ineligible.\n5. Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and\u002For evidence of recurrence after curative surgery.\n6. Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 5 years before ICF signature. Note: Patients with prior or concurrent in situ malignancies are eligible provided that adequate curative treatment is completed prior to enrollment.\n7. Patient has any other concurrent severe and\u002For uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, liver cirrhosis or any other significant liver disease, active untreated or uncontrolled fungal, bacterial or viral infections, active infection requiring systemic antibacterial therapy, etc.) or limit life expectancy to ≤5 years.\n8. Patient participated in another interventional study and received treatment with an investigational product (or used an investigational device) within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer.",{"count":256,"type":22},725,[108],"The purpose of this study is to evaluate the efficacy and safety of ctDNA-guided initiation of CDK4\u002F6 inhibitor therapy using the Signatera™ Designed on Genome test (referred to as \"Signatera Genome\") in participants with intermediate-risk HR+\u002FHER2- early-stage breast cancer. Based on ctDNA test results, participants will either start CDK4\u002F6 inhibitor therapy in addition to hormone therapy or continue hormone therapy with ongoing ctDNA surveillance. This study will compare outcomes to historical controls from the NataLEE trial to determine whether ctDNA-guided timing maintains efficacy while reducing unnecessary treatment. Participants will be followed for up to 9 years with regular blood draws, hormone therapy, imaging as needed, and quality-of-life assessments.",[28,260,261],"Carcinoma, Ductal, Breast","Receptors, Estrogen (for ER-positive Requirement)",[263,264,265,266,267,268,269,270,271,272,273,274,275,276,277,278,279],"ctDNA","Circulating tumor DNA","Signatera","CDK4\u002F6 inhibitor","Ribociclib","Abemaciclib","Molecular residual disease","MRD","Biomarker-guided therapy","Adjuvant therapy","Hormone receptor positive","HER2 negative","Early breast cancer","Intermediate risk breast cancer","breast cancer","Endocrine therapy","Tumor-informed assay","2026-08-11",{"date":141,"type":33},{"date":283,"type":33},"2026-05-08",{"date":285,"type":22},"2037-12-30",{"name":287,"class":40},"Natera, Inc.",48,{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":49,"minAge":19,"maxAge":297,"enrollmentInfo":298,"targetDuration":4,"studyType":299,"phases":4,"briefSummary":300,"conditions":301,"keywords":302,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":307,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":314},"100483350","providence---prospective-non-interventional-study-nis-to-examine-patient-reported-outcomes-and-real-world-clinical-data-in-patients-with-her2-positive-her2-low-or-her2-ultralow-unresectable-or-metastatic-breast-cancer-treated-with-trastuzumab-deruxtecan-100483350","NCT05573893","PROVIDENCE - Prospective Non-interventional Study (NIS) to Examine Patient-reported Outcomes and Real-world Clinical Data in Patients With HER2-positive, HER2-low or HER2-ultralow Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan","Prospective Non-interventional Study (NIS) to Examine Patient-reported Outcomes and Real-world Clinical Data in Patients With HER2-positive, HER2-low or HER2-ultralow Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan","PROVIDENCE","Inclusion Criteria:\n\n1. Adults ≥ 18 years old\n2. Patients (irrespective of sex and gender) with pathologically documented breast cancer that:\n\n   * is unresectable or metastatic\n   * has confirmed HER2+, HER2-low or HER2-ultralow tumor status by local pathology\n   * was previously treated with one or more anti-HER2 directed therapy if the tumor is HER2+ OR\n   * was previously treated with at least one endocrine therapy in the metastatic setting and is not considered suitable for endocrine therapy as the next line of treatment if the tumor is HR+, HER2-low or HER2-ultralow OR\n   * was previously treated with prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy if the tumor is HER2-low.\n3. Has documented radiologic progression (during or after most recent treatment)\n4. Patient is eligible for T-DXd treatment in line with the specifications mentioned in the ENHERTU® SmPC and is scheduled for T-DXd treatment \\*\n5. Patient is able to read and understand either German or English\n6. Signed written informed consent\n\n   * The prescription of the medicinal product is clearly separated from the decision to include the patient in this NIS.\n\nExclusion Criteria:\n\n1. Start of T-DXd treatment for more than 30 days before enrolment (eCRF registration date)\n2. Known hypersensitivity to T-DXd or any of the excipients of the drug\n3. Pregnancy or breast feeding\n4. Current or planned participation in an interventional clinical trial\n5. Current or planned systemic treatment of any tumor other than unresectable or metastatic BC\n\nPatients who have never received any T-DXd dose will be discontinued from the study and will be considered as a late screening failure, no further documentation besides reason and date of discontinuation is needed.","130 Years",{"count":51,"type":22},"OBSERVATIONAL","This is a prospective non-interventional, multicenter study observing patient reported outcomes as well as real-world efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients with documented Human epidermal growth factor receptor 2 (HER2)-positive, HER2-low or HER2-ultralow unresectable or metastatic breast cancer (BC) receiving T-DXd in line with the applicable summary of product characteristics (SmPC) within routine clinical practice in Germany. In addition, patients will be informed about use of digital healthcare application (DiGA).",[28,111,56],[303,304,305,306],"Trastuzumab-Deruxtecan,","Human epidermal growth factor receptor 2 Positive Breast Cancer,","Human epidermal growth factor receptor 2 Low Breast Cancer,","Human epidermal growth factor receptor 2 Ultralow Breast Cancer,",{"date":210,"type":33},{"date":309,"type":33},"2023-09-12",{"date":311,"type":22},"2031-12-31",{"name":313,"class":40},"AstraZeneca",109,{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":321,"eligibilityCriteria":322,"healthyVolunteers":12,"sex":18,"minAge":323,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":23,"phases":326,"briefSummary":327,"conditions":328,"keywords":329,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":345},"100651290","slow-jogging-for-breast-cancer-survivors-100651290","NCT07757763","Slow Jogging for Breast Cancer Survivors","The Effectiveness of Slow Jogging on Sleep, Fatigue, and Quality of Life in Breast Cancer Survivors","SJBC","Inclusion Criteria\n\n1. Female breast cancer survivors aged 20 years or older.\n2. Histologically confirmed hormone receptor-positive breast cancer (Stage I-IV) and considered suitable for exercise intervention by the treating physician.\n3. Completed primary cancer treatment (surgery, chemotherapy, or radiotherapy) within the previous 12 months; participants receiving ongoing anti-HER2 targeted therapy and\u002For endocrine therapy are eligible.\n4. Able to independently operate a smartphone and willing to install and use the study application.\n5. Self-reported sleep disturbance within the previous two weeks, defined as a Single-item Sleep Quality Scale (SQS) score ≥ 6.\n6. Willing to participate and provide written informed consent.\n\nExclusion Criteria\n\n1. History of cancer treatment-related cardiovascular complications or judged by the treating physician to be unsuitable for exercise.\n2. Musculoskeletal disorders affecting lower-extremity function (e.g., plantar fasciitis, knee osteoarthritis, ankle degenerative disease) that limit exercise participation.\n3. Currently participating in another structured moderate- or vigorous-intensity aerobic exercise program (≥3 sessions\u002Fweek, ≥30 minutes\u002Fsession for ≥3 consecutive weeks).\n4. Any other medical or psychological condition judged by the investigator to interfere with safe participation or completion of the study.","20 Years",{"count":325,"type":22},104,[108],"Breast cancer survivors frequently experience persistent sleep disturbance, cancer-related fatigue, and reduced health-related quality of life after completion of primary treatment. Although exercise is recommended as an important component of survivorship care, evidence regarding the effectiveness of slow jogging remains limited. This investigator-initiated, single-center, parallel-group randomized controlled trial aims to evaluate the effectiveness of a standardized 12-week slow jogging exercise program in women aged 20 years or older with hormone receptor-positive Stage I-IV breast cancer who have completed primary cancer treatment within the previous 12 months. Participants will be randomized using permuted block randomization (block size = 6) to receive either a slow jogging intervention plus usual care or usual care alone. The primary outcome is sleep quality measured by the Chinese Pittsburgh Sleep Quality Index (CPSQI). Secondary outcomes include cancer-related fatigue measured by the Taiwanese Brief Fatigue Inventory (BFI-T) and health-related quality of life measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B). Outcomes will be assessed at baseline and at Weeks 4, 8, and 12.",[28],[330,331,332,333,334,335,336],"Breast Cancer Survivors","Slow Jogging","Exercise Therapy","Sleep Quality","Cancer-Related Fatigue","Quality of Life","Randomized Controlled Trial","2026-08-06",{"date":280,"type":33},{"date":340,"type":33},"2026-04-14",{"date":342,"type":22},"2027-01-31",{"name":344,"class":127},"Mackay Memorial Hospital",1,{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":12,"sex":49,"minAge":19,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":23,"phases":354,"briefSummary":355,"conditions":356,"keywords":357,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":361,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":369},"100587321","a-study-of-izalontamab-brengitecan-versus-chemotherapy-in-participants-with-previously-untreated-locally-advanced-recurrent-inoperable-or-metastatic-triple-negative-breast-cancer-ineligible-for-anti-pdl1-drugs-izabright-breast01-100587321","NCT06926868","A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01)","IZABRIGHT-Breast01: A Randomized, Open-label, Phase 2\u002F3 Study of Izalontamab Brengitecan (BMS-986507) Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer (TNBC) or ER-low, HER2-negative BC Who Are Ineligible for Anti-PD1\u002FPD-L1 Treatment","Inclusion Criteria\n\n* Histologically or cytologically confirmed and documented locally-advanced, recurrent inoperable, or metastatic triple-negative breast cancer (TNBC) (ER \\\u003C 1%, PgR \\\u003C 1%, HER2 IHC 0, 1+, or 2+ with ISH negative for HER2 gene amplification) or ER-low, HER2-negative BC (ER and \u002F or PgR 1% to 10%, HER2 IHC 0, 1+, or 2+ with ISH negative for HER2 gene amplification) per American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) criteria, based on the most recently analyzed biopsy or other pathology specimen.\n* Patients with recurrent disease must have experienced disease relapse at least 6 months after finishing their last therapy with curative intent.\n* Participants with TNBC must be considered ineligible for 1L chemotherapy combination treatment with an anti-PD-1 (eg, pembrolizumab) or an anti-PD-L1 (eg, atezolizumab) due to any one of the following criteria:\n\n  i) Investigator-determined ineligibility based on PD-L1 negative disease determined and documented prior to trial screening as part of standard of care (SoC); ii) Has experienced disease relapse between 6 to 12 months after the completion of (neo)adjuvant therapy with an anti-PD(L)1; iii) Has a severe auto-immune disease or other contraindication, in the opinion of the investigator, for the use of an anti-PD(L)1 drug: iv) Any auto-immune disease that requires current immunosuppression (eg, methotrexate, cyclophosphamide, prednisone \\> 10 mg\u002Fday).\n\n  v) Prior auto-immune AE to peri-adjuvant ICI that required immunosuppression. vi) Current Graves' disease with ophthalmopathy or in need of radioiodine or in use of antithyroid medication.\n\nvii) Current or prior auto-immune diseases per below: A. Moderate to severe rheumatoid arthritis. B. Auto-immune hepatitis or cholangitis. C. Myasthenia gravis. D. Moderate-to-severe or poorly controlled inflammatory bowel disease. E. Multiple sclerosis. F. Lupus with kidney involvement or moderate to severe lupus. G. Auto-immune myocarditis. Note: if participant meets Inclusion Criteria 5b or 5c, unknown PDL1 results per local SOC are acceptable in these specific cases.\n\n* Patients with ER-low, HER2-negative BC must be ineligible, in the opinion of the Investigator, for endocrine therapy-based treatments.\n* No previous systemic therapy in the locally advanced, recurrent inoperable or metastatic setting (ie incurable setting).\n* Measurable disease by CT or MRI as per RECIST v1.1.\n\nExclusion Criteria\n\n* Participants with a known germline breast cancer gene (BRCA) 1 or 2 mutation whose best 1L treatment option, in the opinion of the investigator, is a poli-ADP-ribose-polymerase inhibitors (PARPi).\n* Untreated symptomatic central nervous system (CNS) metastases. Participants are eligible if CNS metastases have been treated, and participants' neurological signs and symptoms have returned to baseline. In addition, participants must have been either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization. Imaging performed within 28 days of randomization must document radiographic stability of CNS lesions and be performed after completion of any CNS directed therapy.\n* Leptomeningeal metastases.\n* Participants with history of severe heart disease including, but not limited to, any of the following:\n\n  i) History of clinically significant heart disease (eg, cardiomyopathy, congestive heart failure with New York Heart Association functional classification II to IV, pericarditis, or significant pericardial effusion).\n\nii) Myocardial infarction, uncontrolled angina, or stroke\u002Ftransient ischemic attack within the past 6 months.\n\niii) QTc (by Fridericia's formula) prolongation ≥ 450 msec for males and ≥ 470 msec for females, except for right bundle branch block.\n\niv) Known LVEF \\\u003C 50%.\n\n* Prior therapy with iza-bren or any other ADC targeting EGFR and\u002For HER3 or containing a topoisomerase 1 inhibitor payload.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":21,"type":22},[25,53],"The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician's choice (TPC) (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) for the treatment of first-line metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative BC patients who are not candidates for anti-PD(L)1 therapy and endocrine therapies.",[28],[358,359,360],"triple-negative breast cancer","antibody-drug conjugate","ER-low\u002FHER2-negative breast cancer",{"date":362,"type":33},"2026-08-10",{"date":364,"type":33},"2025-09-11",{"date":366,"type":22},"2030-05-15",{"name":368,"class":40},"Bristol-Myers Squibb",295,{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":376,"eligibilityCriteria":377,"healthyVolunteers":12,"sex":49,"minAge":19,"maxAge":4,"enrollmentInfo":378,"targetDuration":4,"studyType":23,"phases":380,"briefSummary":381,"conditions":382,"keywords":386,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":398},"100609377","phase-1-a-study-of-ly4337713-in-participants-with-fap-positive-solid-tumors-100609377","NCT07213791","A Study of LY4337713 in Participants With FAP-Positive Solid Tumors","A Dose Escalation and Dose Optimization Phase 1a\u002F1b Study to Evaluate Safety, Tolerability and Dosimetry of Radioligand Therapy With LY4337713 in Adults With FAP-Positive Solid Tumors (FiREBOLT)","FiREBOLT","Inclusion Criteria:\n\n* Must have clinical or imaging evidence of fibroblast activation protein (FAP) expression per local assessment\n* Must have histologically or cytologically confirmed diagnosis of one of the following:\n\n  * Adenocarcinoma of the pancreas\n  * Hormone receptor (HR)-positive human epidermal growth factor 2 (HER2)-negative breast cancer\n  * HER2-positive breast cancer\n  * Triple negative breast cancer (TNBC)\n  * Platinum-resistant or refractory ovarian cancer (including ovarian carcinosarcoma)\n  * Other solid tumors\n\n    * Gastric cancer (adenocarcinoma)\n    * Colorectal cancer (CRC)\n    * Esophageal cancer (squamous cell carcinoma or adenocarcinoma)\n    * Cholangiocarcinoma\n* Must have received prior treatments as indicated below:\n\n  * Phase 1a\n\n    * Adenocarcinoma of the pancreas: Participants must have received at least 1, but no more than 2 prior regimens for locally advanced unresectable or metastatic disease.\n    * HR-positive HER2-negative breast cancer: Participants must have received less than or equal to (≤)5 prior lines of treatment for advanced or metastatic disease, which must include a cyclin-dependent kinase 4\u002F6 inhibitor.\n    * HER2-positive breast cancer: Participants must have received at least 2 lines of HER2-targeted therapy, which should include at least 1 antibody-drug conjugate (ADC) for metastatic disease (if locally available).\n    * TNBC: Participants must have received at least 2 lines of therapy for metastatic disease.\n    * Platinum-resistant or refractory ovarian cancer: Participants must have received or after at least 1 platinum-based therapy.\n    * Other solid tumors (gastric cancer, CRC, esophageal and cholangiocarcinoma): Participants must have received greater than or equal to (≥)1 prior line of systemic therapy for advanced or metastatic disease; including prior line(s) in combination with immunotherapy or vascular endothelial growth factor inhibitor.\n  * Phase 1b:\n\n    * Participants must have advanced or metastatic solid tumors and have received ≥1 prior line of therapy.\n* Must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.\n* Measured creatinine clearance ≥60 milliliters per minute (mL\u002Fmin)\n\nExclusion Criteria:\n\n* Have known active central nervous system (CNS) metastases or carcinomatous meningitis.\n* Have significant cardiovascular disease\n* Have prolongation of the corrected QTcF \\>470 milliseconds (msec) during screening. QTcF is calculated using Fridericia's Formula: QTcF = QT\u002F(RR0.33)\n* Have evidence of ongoing and untreated urinary tract obstruction\n* Had previous hemi- or total-body radiation.\n* Had previous adoptive T-cell therapy (e.g., chimeric antigen receptor T-cell \\[CAR-T therapy, T-cell receptor \\[TCR\\] therapy, etc.)\n* Unable to lie flat during, or otherwise tolerate, single photon emission computed tomography (SPECT), positron emission tomography (PET), computed tomography (CT) or magnetic resonance imaging (MRI).",{"count":379,"type":22},241,[78],"This is a study of LY4337713 in participants with certain types of cancer that is advanced or has spread. Participants must have cancer with high levels of a protein called fibroblast activation protein (FAP). The purpose of this study is to evaluate safety, side effects, and efficacy of LY4337713. In addition, this study will evaluate how much LY4337713 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. For each participant, the study will last about 5 years.",[383,28,384,81,85,84,385],"Ovarian Neoplasms","Pancreatic Intraductal Neoplasms","Cholangiocarcinoma",[387,388,389,390],"Cancer-associated fibroblasts (CAF)","Lutetium-177","LuFAP","Lu-177-FAP","2026-08-05",{"date":337,"type":33},{"date":394,"type":33},"2025-10-22",{"date":396,"type":22},"2033-03",{"name":39,"class":40},30,{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":49,"minAge":19,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":23,"phases":409,"briefSummary":410,"conditions":411,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":418,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":425},"100468924","phase-1-study-of-abemaciclib-and-elacestrant-in-participants-with-brain-metastasis-due-to-erher-2--breast-cancer-100468924","NCT05386108","Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+\u002FHER-2- Breast Cancer","An Open-label Multicenter Phase 1b-2 Study of Elacestrant in Combination With Abemaciclib in Women and Men With Brain Metastasis From Estrogen Receptor Positive, HER-2 Negative Breast Cancer","ELECTRA","Inclusion Criteria:\n\n1. Participant has the signed informed consent form before any study-related activities according to local guidelines.\n2. Women or men aged ≥18 years, at the time of informed consent signature.\n\n   * Female participants may be either postmenopausal or pre\u002Fperimenopausal. Postmenopausal status is defined by:\n\n     1. Age ≥60 years\n     2. Age \\\u003C60 years and amenorrhea for 12 or more months without an alternative cause) and follicle stimulating hormone and estradiol in postmenopausal ranges per local reference ranges\n     3. Documentation of prior bilateral oophorectomy, at least 1 month before first dose of trial therapy).\n   * Pre-menopausal \u002F peri-menopausal women and men must be concurrently receiving a luteinizing hormone-releasing hormone (LHRH) agonist starting at least 3-4 weeks before the start of trial therapy and is planning to continue LHRH during the study.\n3. Participant must have ER-positive, HER-2 negative tumor status as confirmed by local laboratory testing in the following manner:\n\n   * Documentation of ER positive tumor with ≥ 1% staining by immunohistochemistry (IHC) as defined in the 2010 or 2020 American Society for Clinical Oncology (ASCO) recommendations for ER testing, with or without progesterone receptor (PGR) positivity\n   * HER-2 negative tumor with an IHC result of 0 or 1+ for cellular membrane protein expression or an in situ hybridization negative result as defined in the 2013 or 2018 ASCO recommendations for HER-2 testing\n4. In Phase 2, participants must have at least one active and measurable brain metastasis per RECIST version 1.1.\n\n   * Any of the following qualifies brain metastases as active:\n\n     1. Newly diagnosed brain metastasis in participants who never received prior central nervous system (CNS)-directed therapy.\n     2. Newly diagnosed brain metastasis outside any area that was previously subjected to CNS-directed therapy.\n     3. Brain metastases demonstrating unequivocal progression in the opinion of the treating investigator in an area that has previously been subjected to CNS-directed therapy.\n   * For lesions, including brain metastases, to qualify as measurable, and possibly be selected as target lesions, per RECIST version 1.1, the longest diameter must be ≥10 millimeters \\[mm\\] by computed tomography \\[CT\\] or magnetic resonance imaging \\[MRI\\]).\n   * In Phase 1b, the presence of brain metastases is allowed but not required for eligibility, in this case, at least 1 measurable lesion outside the brain is required.\n5. Participants receiving concomitant corticosteroids must be on a stable or decreasing dose for at least 7 days prior to baseline and not receiving doses higher than 4 mg of dexamethasone per day or equivalent.\n6. Participants have experienced no more than one seizure within 4 weeks prior to starting trial therapy.\n7. Participants' prior therapy received in the metastatic setting includes:\n\n   * At least one endocrine therapy\n   * Up to two chemotherapy regimens\n   * Up to two lines of prior cyclin-dependent kinase (CDK) 4\u002F6 inhibitor, not including abemaciclib\n\n   Note 1: Toxicity from prior therapy must be resolved to NCI CTCAE version 5.0 Grade ≤1, with the exception of alopecia and peripheral sensory neuropathy (Grade ≤2).\n\n   Note 2: Chemotherapy refers to not targeted cytotoxic agents (for example, alkylating agents, taxanes, nucleotide analogs, platinum-based drugs, vinca alkaloids, etc) and antibody drug conjugates (ADCs). Targeted therapies (for example, kinase inhibitors) are not considered chemotherapy for eligibility purposes. Not targeted cytotoxic agents administered for less than 1 cycle will not be counted as a prior chemotherapy regimen.\n8. Participant has documented intracranial and\u002For extracranial radiological progression or recurrence while on or after the most recent therapy.\n9. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2\n10. Participant has a life expectancy ≥ 12 weeks.\n11. Participant has adequate bone marrow and organ function, as defined by the following laboratory values:\n\n    1. Absolute neutrophil count (ANC) ≥1.5 × 10\\^9\u002Fliter (L)\n    2. Platelets ≥100 × 10\\^9\u002FL\n    3. Hemoglobin ≥9.0 grams (g)\u002Fdeciliter (dL)\n    4. Potassium, sodium, calcium (corrected for serum albumin) and magnesium CTCAE Grade ≤1 (if screening assessments are abnormal, these assessments may be repeated up to 2 times; participants may receive appropriate supplementation or treatment prior to reassessment)\n    5. Creatinine clearance (per Cockcroft-Gault formula) ≥50 mL\u002Fminute\n    6. Serum albumin ≥3.0 g\u002FdL (≥30 g\u002FL)\n    7. Liver function tests:\n\n       In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × upper limit of normal (ULN). If the participant has liver metastases, ALT and AST ≤5.0 × ULN.\n    8. Total serum bilirubin \\\u003C1.5 × ULN except for participants with Gilbert's syndrome who may be included if the total serum bilirubin is ≤3.0 × ULN or direct bilirubin ≤ 1.5 × ULN\n12. The participant is willing and able to adhere to the study visit schedule and other protocol requirements.\n\nExclusion Criteria:\n\n1. Immediate CNS-specific treatment is likely to be required, per the treating physician's assessment.\n2. Participant has imminent organ failure and\u002For visceral crisis.\n3. Participant has leptomeningeal metastases, defined as having positive cerebrospinal fluid (CSF) cytology or unequivocal radiologic and clinical evidence of leptomeningeal involvement. Note: Discrete dural metastases are permitted.\n4. Breast cancer treatment-naïve participants (that is, not having received any systemic therapy) in the advanced\u002Fmetastatic setting.\n5. History of pulmonary embolism (PE), cardiovascular accident (CVA), myocardial infarction (MI) in the past 6 months from screening visit.\n6. Prior therapy with abemaciclib in the metastatic setting. Note: Use of abemaciclib in the adjuvant setting is allowed if the last treatment administration was more than 12 months prior to first recurrence.\n7. Prior therapy with elacestrant or other investigational selective estrogen receptor degraders (SERDs), or investigational alike agents such as selective estrogen receptor modulators (SERMs), selective estrogen receptor covalent antagonists (SERCANs), complete estrogen receptor antagonists (CERANs), and proteolysistargeting chimeras (PROTACs) in the metastatic setting.\n8. Participant has a concurrent malignancy or malignancy within 3 years of enrollment, with the exception of adequately treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or second primary breast cancer; and any other malignancy that is considered in complete remission by the Investigator(s) that is approved by the Medical Monitor.\n9. Currently participating in another breast cancer intervention clinical study. Participants who are being followed for overall survival for another clinical trial with no therapy and study intervention are allowed after the washout period for any prior therapy.\n10. Prior anti-cancer or investigational drug treatment within the following windows:\n\n    * Fulvestrant treatment (last injection) \\\u003C42 days before first dose of study drug\n    * Any other endocrine therapy \\\u003C14 days before first dose of study drug. Note: LHRH agonists should not be counted as endocrine therapy.\n    * Chemotherapy or other anti-cancer therapy \\\u003C14 days before first dose of study drug\n    * Any investigational anti-cancer drug therapy within \\\u003C28 days or \\\u003C5 half lives, whichever is shorter\n    * Bisphosphonates or receptor activator of nuclear factor-κB ligand (RANKL) inhibitors initiated, or dose changed \\\u003C1 month prior to first dose of study drug according to institutional guidelines.\n11. Radiation therapy (including CNS directed) within 7 days before the first dose of study drug or without a full recovery from radiotherapy acute effects.\n12. Uncontrolled significant active infections\n\n    * Participants with hepatitis B virus (HBV) and\u002For hepatitis C virus (HCV) infection must have undetectable viral load (or detected below the lower limit of quantification) during screening\n    * Participants known to be human immunodeficiency virus positive (HIV+) are allowed as long as they have undetectable viral load (viral suppression) at baseline.\n13. Major surgery within 4 weeks of starting trial therapy.\n14. Inability to take oral medication, or history of malabsorption syndrome or any other uncontrolled gastrointestinal condition that may significantly alter the absorption of study drugs.\n15. Females of childbearing potential who do not agree to use a highly effective non-hormonal method of contraception and to abstain from donating ova within 28 days of the first dose of study treatment through 120 days after the last dose of study treatment. Highly effective non-hormonal method of contraception includes any of the following:\n\n    1. Intrauterine device (non-hormonal)\n    2. Sexual abstinence\n    3. Bilateral tubal occlusion\u002Fligation\n    4. Have a vasectomized partner with confirmed azoospermia.\n16. Male participants (including males after a vasectomy) with a pregnant or non-pregnant female of childbearing potential partner who do not agree to use a highly effective barrier contraception method (condoms) within 28 days of the first dose of study treatment until 120 days of the last dose of study treatment. And male participants who do not agree to abstain from freezing or donating sperm within the same period. In addition, female partners of childbearing potential, of male participants (who has not undergone vasectomy) must use highly effective methods of contraception.\n17. Females who are pregnant or breastfeeding. Females should not get pregnant during study treatment and for 120 days after last dose of study treatment. Females should not breastfeed during administration of elacestrant and for 1 week after receiving the last dose.\n18. Known intolerance to either study drug or any of their excipients.\n19. Participants currently receiving or received any of the following medications prior to first dose of trial therapy:\n\n    1. Known strong or moderate inducers or inhibitors of cytochrome P450 (CYP) 3A4 (including foods and herbal preparations) within 14 days or \\\u003C5 half-lives, whichever is shorter)\n    2. Herbal preparations\u002Fmedications (which are not strong or moderate inducers or inhibitors of CYP3A4). These include, but are not limited to, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng within 7 days prior to initiating trial therapy\n    3. Vaccination, including but not limited to vaccination against coronavirus disease-19 (COVID-19), during the 7 days prior to randomization.\n20. Any severe medical or psychiatric condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study.",{"count":408,"type":22},73,[78,25],"This is a multi-site, global, open-label study that includes a phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with brain metastases from estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER-2) negative breast cancer. Phase 1b was designed to select the recommended phase 2 dose (RP2D) and is followed by an ongoing phase 2 evaluation of elacestrant in combination with abemaciclib in participants with active brain metastases from ER-positive, HER-2 negative breast cancer.",[28,412,413,113,414,415,416,417],"Brain Neoplasms","Neoplasms by Site","Breast Diseases","Central Nervous System Neoplasms","Brain Diseases","Central Nervous System Diseases",{"date":337,"type":33},{"date":420,"type":33},"2022-08-31",{"date":422,"type":22},"2026-12",{"name":424,"class":40},"Stemline Therapeutics, Inc.",86,{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":4,"eligibilityCriteria":432,"healthyVolunteers":12,"sex":49,"minAge":19,"maxAge":4,"enrollmentInfo":433,"targetDuration":4,"studyType":23,"phases":435,"briefSummary":436,"conditions":437,"keywords":438,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":454},"100606299","phase-3-rosetta-breast-01-the-effects-and-safety-of-pumitamig-in-patients-with-triple-negative-breast-cancer-100606299","NCT07173751","ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer","A Phase III, Multisite, Randomized, Double-Blind Trial of BNT327 in Combination With Chemotherapy Versus Placebo With Chemotherapy in Patients With Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC Determined Ineligible for PD(L)1 Therapy Based on PD-L1 Negative Disease","Inclusion Criteria:\n\n* Are considered ineligible for combination treatment with a monospecific PD(L)1 targeting immunotherapy plus chemotherapy as per their tumor PD-L1 expression status.\n* Have confirmed locally recurrent inoperable or metastatic TNBC, or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative breast cancer (ER and\u002For progesterone receptor \\[PgR\\]) 1% to 10%, HER2 immunohistochemistry \\[IHC\\] 0, 1+, or 2+ with fluorescence in situ hybridization \\[FISH\\] negative for HER2 gene amplification) documented prior to trial screening as part of standard of care.\n* Have at least one measurable lesion as the targeted lesion based on RECIST v1.1.\n* Have provided a tissue sample, archival or fresh, during the screening period (bone biopsies, fine needle aspiration biopsies, and samples from pleural or peritoneal fluid are not acceptable; participants with only one target lesion are not eligible to participate in the trial).\n* Eastern cooperative oncology group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n* Have received any of the following therapies or drugs prior to the initiation of trial:\n\n  * Have received prior systemic anticancer therapy for advanced disease.\n  * Have received prior treatment with a PD(L)-1\u002Fvascular endothelial growth factor (VEGF) bispecific antibody.\n  * Have received systemic corticosteroids (at a dosage greater than 10 milligrams \\[mg\\]\u002Fday of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of trial treatment. Exception: excluding local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (\\\u003C= 7 days) of corticosteroids for prophylaxis (for example, prevention of contrast agent allergy) or treatment of non-autoimmune conditions (for example, delayed hypersensitivity reactions caused by exposure to allergens).\n  * Have been vaccinated with live attenuated vaccine(s) within 4 weeks prior to initiation of trial treatment.\n  * Have received broad-spectrum intravenous antibiotics therapy within 2 weeks prior to initiation of trial treatment.\n* Are pregnant or breastfeeding or are planning pregnancy or planning to father children during the trial or within 6 months after the last dose of pumitamig or placebo.\n* Have undergone major organ surgery, significant trauma, or invasive dental procedures (such as dental implants) within 28 days prior to the initiation of trial treatment or plan to undergo elective surgery during the trial. Placement of vascular infusion devices is allowed.\n* Have received allogeneic hematopoietic stem cell transplantation or organ transplantation.",{"count":434,"type":22},558,[53],"This is a Phase III trial where participants will be randomized to two treatment groups, which means participants will be assigned by equal chance to a treatment group. This trial will be double-blinded, which means neither the participants nor the trial doctors will know which of the two treatments the participants actually receive. Participants will receive either the trial drug with chemotherapy or placebo (which looks like the trial drug but does not have any drug in it) with chemotherapy.",[28],[439,440,441,442,443,444],"Metastatic TNBC","Bispecific antibody","Programmed death-ligand 1 (PD-L1)","Immunotherapy","Immunotherapy in combination with chemotherapy","Combination with other investigational agents","2026-07-31",{"date":447,"type":33},"2026-08-03",{"date":449,"type":33},"2025-10-30",{"date":451,"type":22},"2030-09",{"name":453,"class":40},"BioNTech SE",161,{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":461,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":18,"minAge":463,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":23,"phases":466,"briefSummary":467,"conditions":468,"keywords":473,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":345},"100425138","breast-cancer-reasoning-and-activity-intervention-100425138","NCT04816006","Breast Cancer, Reasoning, and Activity Intervention","Enhancing Cognitive Function in Breast Cancer Survivors Through Community-based Exercise Training","BRAIN","Inclusion Criteria\n\n* PRE-REGISTRATION: Age ≥50 years at time of pre-registration visit according to participant report and\u002For clinical determination\n* PRE-REGISTRATION: First, primary diagnosis of stage I-IIIa breast cancer according to participant report and\u002For clinical determination\n* PRE-REGISTRATION: Post-surgery and completed primary treatment (i.e., surgery, chemotherapy, and\u002For radiation therapy) 3-60 months prior to registration according to participant report and\u002For clinical determination\n* PRE-REGISTRATION: Sedentary except for casual lifestyle recreation defined as self-reporting no more than 90 minutes per week of moderate-intensity aerobic exercise within the last 6 months\n* PRE-REGISTRATION: Self-reported ability to complete assessments by themselves or with assistance\n* REGISTRATION: Age ≥50 years as confirmed via clinical determination\n* REGISTRATION: Able to provide medical record release to confirm eligibility\n* REGISTRATION: First, primary diagnosis of stage I-IIIa breast cancer as confirmed via clinical determination\n* REGISTRATION: Post-surgery and completed primary treatment (i.e., surgery, chemotherapy, and\u002For radiation therapy) 3-60 months prior to pre-registration as confirmed via clinical determination\n* REGISTRATION: No evidence of possible cognitive impairment as assessed using the Telephone Interview of Cognitive status (13-item modified version) (TICS-M; score \\> 21) NOTE: Only individuals who pass the TICS-M during pre-registration will be invited to participate in the urine substudy\n* REGISTRATION: Receive physician's clearance to participate in an exercise program\n\nNOTE: Individuals with conditions\u002Fdiagnoses deemed important by the primary investigator will be required to provide clearance for exercise from their cardiologist. Example conditions include:\n\n* History of major multiple myocardial infarctions (MI)\n* Recent electrocardiogram (ECG) changes or recent MI\n* Resting or unstable angina\n* Significant multivessel coronary occlusion (≥ 70%) on angiography\n* Uncontrolled and\u002For serious arrhythmias\n* 3rd degree heart block\n* Acute congestive heart failure or ejection fraction \\\u003C 30%\n\n  * REGISTRATION: Ability to complete assessments by themselves or with assistance\n\nExclusion Criteria:\n\n* PRE-REGISTRATION: Stage 0 breast cancer diagnosis OR metastatic disease\n* PRE-REGISTRATION: Currently receiving or \\\u003C 3 months since receiving chemotherapy or radiation therapy for cancer, or greater than 60 months post primary treatment\n* PRE-REGISTRATION: Planned surgery during the intervention period\n* PRE-REGISTRATION: Second cancer diagnosis (excluding non-invasive skin cancers or carcinoma-in-situ for any cancer)\n* PRE-REGISTRATION: Unable to travel regularly to the study locations for intervention sessions and data collection\n* PRE-REGISTRATION: Unwilling to return to enrolling institution for follow-up\n* PRE-REGISTRATION: Self-reported inability to walk without assistance or devices\n* REGISTRATION: History of stroke, transient ischemic attack, other neurological disorders, or brain surgery involving tissue removal as confirmed via clinical determination\n* REGISTRATION: Clinically significant TICS-M score (\\\u003C 21) during baseline procedures\n* REGISTRATION: Not able to provide physician re-clearance for exercise if required based upon clinically significant baseline exercise test (as determined by ECG and blood pressure monitoring)\n* REGISTRATION: Contraindications to functional magnetic resonance imaging (fMRI) in accordance with the Mayo Clinic Department of Radiology safety protocols\n* REGISTRATION: Clinically significant MRI scan as determined by physician review in which the following is advised via radiologist overread: remarkable\u002Fabnormal limited diagnostic brain image with recommended medical follow-up\n* REGISTRATION: Enrolled in another physical activity program\n* REGISTRATION: Unable to walk without assistance or devices\n* REGISTRATION: Unwilling to complete study requirements\n* REGISTRATION: Unwilling to be randomized to the exercise group or health education group\n* REGISTRATION: Unable or unwilling to continuously wear and regularly sync\u002Fcharge an activity tracker during the study period\n* REGISTRATION: Unable to travel regularly to the study locations for intervention sessions and data collection\n* REGISTRATION: Unwilling to return to enrolling institution for follow-up","50 Years",{"count":465,"type":22},160,[108],"This phase II trial tests whether an exercise intervention works to improve cognitive function in breast cancer survivors. Many breast cancer survivors report cancer-related cognitive impairment, which this has recently become a priority in clinical research due to its dramatic impact on daily functioning, quality of life, and long-term health. Aerobic exercise has the potential to improve cognitive function and brain health in older adults and is recommended as a safe, tolerable, and accessible complementary therapy for breast cancer survivors. This study aims to understand the effects of physical activity compared with health education on memory, attention, and brain health in women with breast cancer. Study findings may help researchers design more programs that can improve memory, attention, and brain health in other women with breast cancer.",[111,28,469,470,471,472],"Anatomic Stage I Breast Cancer AJCC v8","Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage IIIA Breast Cancer AJCC v8","Cancer-related Cognitive Dysfunction",[474,475,476,477,277],"physical activity","exercise","cognition","brain health","2026-07-30",{"date":445,"type":33},{"date":481,"type":33},"2024-02-22",{"date":483,"type":22},"2028-07-31",{"name":485,"class":127},"Mayo Clinic",{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":492,"eligibilityCriteria":493,"healthyVolunteers":12,"sex":49,"minAge":19,"maxAge":494,"enrollmentInfo":495,"targetDuration":4,"studyType":299,"phases":4,"briefSummary":497,"conditions":498,"keywords":499,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":516},"100579932","a-non-interventional-study-for-kisqali-ribociclib-in-combination-with-an-aromatase-inhibitor-for-adjuvant-treatment-in-patients-with-hrher2--early-breast-cancer-at-high-risk-of-recurrence-100579932","NCT06830720","A Non-interventional Study for Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor for Adjuvant Treatment in Patients With HR+\u002FHER2- Early Breast Cancer at High Risk of Recurrence","A Non-interventional Study for Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor for Adjuvant Treatment in Patients With HR+\u002FHER2- Early Breast Cancer at High Risk of Recurrence to Evaluate Real-world Effectiveness, Safety Profile, Patient Compliance and Quality of Life","CAROLEEN","Inclusion Criteria:\n\n* Histological diagnosis of HR+\u002FHER2- early breast cancer with curative intent\n* Patients must have an indication for a treatment with ribociclib + AI ± LHRH as described in the current SmPC\u002F\"Fachinformation\" of ribociclib (to be included into the cohorts of ribociclib + AI ± LHRH and ET mono ± LHRH) or abemaciclib + ET ± LHRH as described in the current SmPC\u002F\"Fachinformation\" of abemaciclib (to be included into the abemaciclib + ET ± LHRH cohort) in the adjuvant setting\n* Before enrollment the treating physician has made the decision in accordance with the patient to treat the patient with either\n\n  * ribociclib + AI ± LHRH, or\n  * ET mono ± LHRH, or\n  * abemaciclib + ET ± LHRH and baseline is no longer than 2 weeks (14 days) prior to written informed consent for this study.\n\nBaseline = for ribociclib + AI ± LHRH cohort: date of therapy start; for abemaciclib + ET ± LHRH cohort: date of therapy start; for ET mono ± LHRH cohort: within 4 weeks after therapy start or within 4 weeks after last non-endocrine based therapy, whichever is last.\n\n* ≥18 years of age\n* Written informed consent\n\nExclusion Criteria:\n\n\\- Patient is simultaneously participating in any investigational trial or simultaneously participating in another Novartis-sponsored non-interventional study with ribociclib.","100 Years",{"count":496,"type":22},3250,"This non-interventional observational study evaluates the real-world effectiveness and safety profile of ribociclib in combination with an aromatase inhibitor for adjuvant treatment in patients with HR+\u002FHER2- early breast cancer at high risk of recurrence, as well as patient compliance and quality of life.",[28],[500,501,277,502,503,504,505,506,507],"Non-interventional study","NIS","early breast cancer","HR+","HER-","ribociclib","real world evidence","adjuvant therapy","2026-07-29",{"date":478,"type":33},{"date":511,"type":33},"2025-02-20",{"date":513,"type":22},"2030-06-30",{"name":515,"class":40},"Novartis Pharmaceuticals",287,{"id":518,"slug":519,"hasResults":12,"nctId":520,"briefTitle":521,"officialTitle":522,"acronym":523,"eligibilityCriteria":524,"healthyVolunteers":102,"sex":49,"minAge":19,"maxAge":4,"enrollmentInfo":525,"targetDuration":4,"studyType":299,"phases":4,"briefSummary":526,"conditions":527,"keywords":534,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":345},"100649958","methylation-profile-test-methylscape-in-body-fluids-for-multi-cancer-detection-and-monitoring-in-colombia-100649958","NCT07741435","Methylation Profile Test (Methylscape) in Body Fluids for Multi-Cancer Detection and Monitoring in Colombia","Evaluation of a Rapid Test for the Detection of Methylation Profiles (Methylscape) in Various Body Fluids as a Universal Biomarker for Cancer Detection and Monitoring","METHYLSCAPE-CO","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Willing and able to participate and to provide the required samples (blood, urine, saliva) and demographic information (age, sex, race\u002Fethnicity, BMI).\n* Able to provide written informed consent for participation and for use of biological samples. For CTIC Biobank samples, prior research-use consent is verified.\n* Demographic\u002Fanthropometric comparability (race, ethnicity, BMI) with other participants; race\u002Fethnicity by self-identification (WHO and national census categories); BMI per WHO categories.\n\nInclusion - Cancer cohort:\n\n* Cancer diagnosis confirmed within 90 days prior to sample collection.\n* Biopsy-proven malignancy with radiological staging.\n* No anticancer treatment at the time of collection or within the previous 3 years.\n* Inclusion - Cancer-free (healthy) cohort:\n* No cancer diagnosis or treatment in the previous 3 years (ICD-O-3 behavior code 2 or 3).\n* Not under evaluation for suspected cancer (verified by medical record review or additional medical evaluation).\n* Subjects with benign tumors (code 0) or tumors of uncertain behavior (code 1) may be included if there is no clinical evidence of progression or malignancy.\n\nAdditional criteria - tumor-burden monitoring (Sub-study 2b):\n\n* Biopsy-confirmed cancer.\n* ECOG performance status ≤ 2.\n\nExclusion Criteria (both cohorts):\n\n* Failure to meet the general or cohort-specific inclusion criteria.\n* Pregnancy.\n* Organ transplant recipients.\n* Use of demethylating agents (azacitidine, decitabine) or cytotoxic agents (including for autoimmune\u002Finflammatory conditions).\n* Prior or ongoing anticancer therapy: cancer surgery beyond that needed for diagnosis; local, regional, or systemic chemotherapy (including chemoembolization); targeted therapy; immunotherapy (including cancer vaccines); hormonal therapy; or radiotherapy.",{"count":496,"type":22},"DNA methylation changes occur early and broadly during carcinogenesis. Methylscape is a rapid assay that detects global DNA methylation patterns in body fluids (blood, urine, and saliva) and may detect a cancer signal and predict the cancer signal origin (CSO) from a single fluid sample, using the differential interaction between methylated and unmethylated DNA and gold nanoparticles.\n\nThis prospective observational study evaluates the diagnostic performance (sensitivity and specificity) of the Methylscape test in Colombian patients with various biopsy-confirmed solid tumors compared with age- and sex-matched cancer-free (healthy) volunteers. The study is conducted in three parts: Phase 1 validates the assay in 250 patients with cancer; Sub-study 2a compares 1,500 patients with cancer against 1,500 matched cancer-free volunteers; and Sub-study 2b uses serial blood and urine sampling in 300 patients with early-stage disease to assess detection of disease relapse during follow-up, in parallel with standard imaging.\n\nThe study also estimates positive and negative predictive values (PPV\u002FNPV) and projects the budget impact and cost-effectiveness of Methylscape as a multi-cancer early detection (MCED) tool in an upper-middle-income Latin American setting.",[113,528,28,529,84,530,81,531,532,234,533],"Solid Tumor","Lung Neoplasms","Uterine Cervical Neoplasms","Urologic Neoplasms","Head and Neck Neoplasms","Neoplasm Recurrence, Local",[535,536,537,538,539,540,541,542,543,544],"DNA methylation","Liquid biopsy","Cell-free DNA (cfDNA)","Multi-cancer early detection (MCED)","Methylscape","Cancer signal origin","Minimal residual disease","Methylation biomarker","Cancer screening","Colombia","2026-07-28",{"date":447,"type":33},{"date":548,"type":33},"2025-06-05",{"date":550,"type":22},"2028-01-15",{"name":552,"class":127},"Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo",{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":559,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":49,"minAge":19,"maxAge":4,"enrollmentInfo":561,"targetDuration":4,"studyType":299,"phases":4,"briefSummary":563,"conditions":564,"keywords":574,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":587,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":592,"locationsCount":345},"100649713","benchmarking-large-language-models-against-tumour-boards-for-oncology-treatment-recommendations-100649713","NCT07739121","Benchmarking Large Language Models Against Tumour Boards for Oncology Treatment Recommendations","Benchmarking AI for Clinical Oncology decisioNmaking (BEACON): A Prospective, Multicentre, Blinded Evaluation of Frontier Large Language Models Against Multidisciplinary Tumour Board Recommendations in Oncology Treatment Planning","BEACON","Inclusion Criteria:\n\n* Synthetic oncology case within one of the five predefined localisations (breast, lung, urological, digestive, gynaecological).\n* Complete structured schema: UICC 8th-edition stage, biomarkers, ECOG performance status, comorbidities and a standardised clinical question.\n* A clinically answerable treatment-planning question that is mappable to the locked guideline matrix.\n\nExclusion Criteria:\n\n* Case outside the five predefined localisations.\n* Incomplete, internally inconsistent or ambiguous schema.\n* Duplicate or near-duplicate of an existing case in the set.\n* Question not resolvable by current guidelines.",{"count":562,"type":22},100,"BEACON (Benchmarking AI for Clinical Oncology decisioNmaking) is a prospective, multicentre, comparative, blinded, non-interventional benchmark evaluating the treatment recommendations of five frontier large language models (LLMs) against the recommendations of multidisciplinary tumour boards (RCP) in oncology treatment planning. One hundred standardised synthetic cases (20 per localisation, across breast, lung, urological, digestive and gynaecological cancers) are submitted as identical structured input to two independent tumour boards per localisation and to five frontier LLMs. Each recommendation - human or model - is decomposed into five predefined decision domains (intent, surgery, radiotherapy, systemic therapy, work-up and biomarkers) and scored 0\u002F1\u002F2 for concordance against a two-tier reference: the consensus of the two tumour boards, complemented by an a priori locked guideline matrix (ESMO, NCCN). The primary endpoint is domain-level concordance between LLM and RCP consensus, expressed as a linearly weighted Cohen's kappa. A co-primary safety endpoint captures the proportion of recommendations carrying serious harm potential, because concordance alone can conceal dangerous errors. Because expert boards may disagree with one another on identical cases, model performance is always interpreted against the human consensus. BEACON is designed as reusable, openly licensed, pre-registered infrastructure: all synthetic cases, evaluation rubrics, the locked guideline matrix, scoring algorithms and verbatim prompts are released for full reproducibility.",[28,529,531,565,566,567,568,569,570,571,572,573],"Prostatic Neoplasms","Urinary Bladder Neoplasms","Kidney Neoplasms","Digestive System Neoplasms","Genital Neoplasms","Artifical Intelligence","Large Language Models","Decision Making","Decision Support Systems, Clinical",[571,575,576,573,577,578,579,113,580,581,582,583,584,585,586],"Artificial Intelligence","Clinical Decision support","Multidisciplinary tumour board (RCP)","Patient Care Team","Medical oncology","Benchmark","Benchmarking","Concordance","Weighted kappa","Synthetic data","Patient safety","Reproductibility",{"date":445,"type":33},{"date":589,"type":33},"2026-05-01",{"date":591,"type":22},"2026-10-01",{"name":593,"class":127},"Assistance Publique - Hôpitaux de Paris",{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":600,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":299,"phases":4,"briefSummary":603,"conditions":604,"keywords":605,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":607,"startDateStruct":608,"completionDateStruct":610,"leadSponsor":611,"locationsCount":612},"100598333","screening-tool-artificial-intelligence-based-for-predicting-the-genetic-risk-of-breast-cancer-100598333","NCT07070128","Screening Tool Artificial Intelligence-based for Predicting the Genetic Risk of BREAST Cancer","Screening Tool Artificial Intelligence-based for Predicting the Genetic Risk of BREAST Cancer (STAR-BREAST)","STAR-BREAST","Inclusion Criteria:\n\n* female patients,\n* aged 18 years or older,\n* identified as high genetic risk by breast surgeons,\n* referred to a geneticist, and\n* who agree to participate in the study.\n\nExclusion Criteria:\n\n* male patients,\n* absence of complete information in the medical records,\n* patients unaware of their biological family history, and\n* patients who do not agree to participate in the study.",{"count":51,"type":22},"It is a retrospective observational study that will include female patients aged 18 years or older, who were treated between 2017 and 2024, in both public and private institutions, and identified as at high genetic risk by breast specialists and referred to a geneticist. The artificial intelligence-based tool to be used in this study is developed by the startup WeConecta, which will collect data via WhatsApp about the patients' family cancer history with the aim of predicting the genetic risk of developing breast cancer.",[28],[111,575,606],"Genetic Risk",{"date":508,"type":33},{"date":609,"type":33},"2025-08-20",{"date":280,"type":22},{"name":313,"class":40},3,{"id":614,"slug":615,"hasResults":12,"nctId":616,"briefTitle":617,"officialTitle":618,"acronym":4,"eligibilityCriteria":619,"healthyVolunteers":12,"sex":18,"minAge":203,"maxAge":4,"enrollmentInfo":620,"targetDuration":4,"studyType":23,"phases":622,"briefSummary":623,"conditions":624,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":627,"lastUpdatePostDateStruct":628,"startDateStruct":630,"completionDateStruct":632,"leadSponsor":634,"locationsCount":345},"100245694","phase-2-endocrine-treatment-alone-for-elderly-patients-with-estrogen-receptor-positive-operable-breast-cancer-and-low-recurrence-score-100245694","NCT02476786","Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score","Endocrine Treatment Alone as Primary Treatment for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score","Inclusion Criteria:\n\n* Newly diagnosed histologically or cytologically confirmed operable invasive breast cancer defined as cT1 or T2, N0-1, and M0.\n* Disease must be ER+ and HER2-.\n* Ki67 score\u002Fproliferative index ≤ 30% or low to intermediate mitotic index\n* Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) by ultrasound or mammogram.\n* 70 years of age or older.\n* ECOG performance status ≤ 3\n* Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).\n\nExclusion Criteria:\n\n* Prior surgery for this cancer\n* A history of other malignancy ≤ 5 years previous which would preclude endocrine treatment of their cancer.\n* Currently receiving any other investigational agents.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the agents used in the study.\n* Uncontrolled intercurrent illness as determined by their treating physician which would limit compliance with study requirements.\n* Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with endocrine therapies. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.",{"count":621,"type":22},50,[25],"Multiple neoadjuvant endocrine trials demonstrate that women with good prognosis tumors can be identified. These trials have also demonstrated that there are not adverse effects on overall outcome if women are treated with neoadjuvant endocrine therapy for several months prior to definitive treatment. A new standard of care needs to be defined for elderly women with good prognosis estrogen receptor (ER)+ tumors, since these women may benefit from endocrine therapy alone to treat their cancer without compromising local and distant control. The investigators hypothesize that endocrine therapy alone provides adequate local and systemic control of breast cancer in a subpopulation of women 70 or older with ER+ breast cancer and low Ki67 scores.",[111,625,28,626],"Cancer of Breast","Cancer of the Breast","2026-07-24",{"date":629,"type":33},"2026-07-27",{"date":631,"type":33},"2017-01-17",{"date":633,"type":22},"2032-07-31",{"name":635,"class":127},"Washington University School of Medicine",{"id":637,"slug":638,"hasResults":12,"nctId":639,"briefTitle":640,"officialTitle":641,"acronym":4,"eligibilityCriteria":642,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":643,"targetDuration":4,"studyType":299,"phases":4,"briefSummary":644,"conditions":645,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":647,"lastUpdatePostDateStruct":648,"startDateStruct":650,"completionDateStruct":652,"leadSponsor":654,"locationsCount":657},"100645532","pre-treatment-dce-mri-ai-models-predict-neoadjuvant-chemotherapy-response-in-hrher2--breast-cancer-100645532","NCT07702708","Pre-Treatment DCE-MRI AI Models Predict Neoadjuvant Chemotherapy Response in HR+\u002FHER2- Breast Cancer","A Multicenter Prospective Observational Cohort Study: Predicting Neoadjuvant Chemotherapy Response Using Pre-Treatment DCE-MRI-Based AI Models in HR+\u002FHER2- Breast Cancer","Inclusion Criteria:\n\n1. Female patients aged ≥ 18 years old.\n2. Histopathologically confirmed invasive breast carcinoma.\n3. Hormone receptor positive (ER and\u002For PR ≥1%), HER2-negative status (IHC 0-1+, or IHC 2+ with negative FISH result).\n4. Clinical stage II-III breast cancer per the 8th AJCC staging system, with clinical indication for neoadjuvant chemotherapy or primary surgery.\n5. Standard pre-treatment breast DCE-MRI performed before neoadjuvant chemotherapy, with image quality eligible for AI model analysis.\n6. ECOG performance status 0 or 1; adequate function of major vital organs to tolerate planned clinical treatment.\n7. Voluntary participation with written informed consent obtained.\n\nExclusion Criteria:\n\n1. Prior systemic anti-tumor therapy for breast cancer other than planned neoadjuvant chemotherapy.\n2. Inflammatory breast cancer or distant metastatic disease (M1).\n3. Concurrent active malignant tumors of other origins.\n4. Contraindications to MRI examination or unqualified MRI images that cannot support model analysis.\n5. Severe comorbidities incompatible with neoadjuvant chemotherapy or surgical resection.\n6. Any other conditions judged ineligible for enrollment by the investigator.",{"count":562,"type":22},"This study is a multicenter, prospective, observational cohort study to evaluate the predictive performance of pre-treatment DCE-MRI-based artificial intelligence (AI) models for neoadjuvant chemotherapy benefit in HR+\u002FHER2- breast cancer. The study plans to enroll eligible HR+\u002FHER2- breast cancer patients receiving routine standard neoadjuvant chemotherapy and stratify participants into high-benefit and low-benefit subgroups via the established AI model based on baseline breast DCE-MRI images.\n\nAll enrolled patients will undergo systematic collection of baseline clinical-pathological data, pre-treatment DCE-MRI scans, neoadjuvant chemotherapy regimens, postoperative residual cancer burden (RCB) classification, objective response rate (ORR), and long-term survival endpoints including disease-free survival (DFS) and overall survival (OS). The primary objective compares the rate of RCB 0-1 between AI-defined high-benefit patients and published historical control data; secondary analyses compare ORR, RCB 0-1 proportion, DFS and OS between AI-stratified high-benefit and low-benefit subgroups to comprehensively verify the clinical value of this imaging AI model for individualized neoadjuvant chemotherapy selection.",[646,28],"HR+\u002FHER2- Breast Cancer","2026-07-13",{"date":649,"type":33},"2026-07-14",{"date":651,"type":33},"2026-06-01",{"date":653,"type":22},"2027-06-30",{"name":655,"class":656},"Fujian Cancer Hospital","OTHER_GOV",5,{"id":659,"slug":660,"hasResults":12,"nctId":661,"briefTitle":662,"officialTitle":663,"acronym":4,"eligibilityCriteria":664,"healthyVolunteers":102,"sex":18,"minAge":665,"maxAge":666,"enrollmentInfo":667,"targetDuration":4,"studyType":23,"phases":669,"briefSummary":670,"conditions":671,"keywords":4,"overallStatus":209,"whyStopped":4,"lastUpdateSubmitDate":672,"lastUpdatePostDateStruct":673,"startDateStruct":674,"completionDateStruct":676,"leadSponsor":678,"locationsCount":345},"100645556","ultrasound-screening-for-early-detection-of-breast-cancer-in-elderly-women-a-mixed-cluster-individual-rct-100645556","NCT07698366","Ultrasound Screening for Early Detection of Breast Cancer in Elderly Women: A Mixed Cluster-Individual RCT","A Multicenter, Open-label, Mixed Cluster-Individual Randomized Controlled Study on the Efficacy of Breast Cancer Ultrasound Screening","Inclusion Criteria:\n\n* Female participants aged 65-80 years.\n* Local residents living in participating communities for ≥6 months.\n* Signed informed consent and willingness to participate.\n\nExclusion Criteria:\n\n* History of breast cancer or previous breast cancer treatment.\n* Breast cancer screening within the past 2 years.\n* Severe comorbid conditions that may affect study participation or follow-up.\n* Acute breast disease or conditions requiring immediate treatment.\n* Unable to cooperate with screening procedures due to physical or cognitive limitations.","65 Years","80 Years",{"count":668,"type":22},82440,[108],"This multicenter study aims to evaluate whether active breast ultrasound screening can improve the early diagnosis rate of breast cancer in women aged 65 to 80 years, compared with routine elderly health management. The study uses a mixed cluster-individual randomized design based on community implementation capacity. A subgroup of pilot communities will simultaneously collect ultrasound AI data for research performance analysis only, without affecting clinical diagnosis.",[28,234],"2026-07-12",{"date":649,"type":33},{"date":675,"type":22},"2026-07-10",{"date":677,"type":22},"2029-12-31",{"name":679,"class":127},"The First Affiliated Hospital with Nanjing Medical University",{"id":681,"slug":682,"hasResults":12,"nctId":683,"briefTitle":684,"officialTitle":685,"acronym":686,"eligibilityCriteria":687,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":688,"targetDuration":4,"studyType":23,"phases":689,"briefSummary":690,"conditions":691,"keywords":694,"overallStatus":209,"whyStopped":4,"lastUpdateSubmitDate":702,"lastUpdatePostDateStruct":703,"startDateStruct":704,"completionDateStruct":705,"leadSponsor":707,"locationsCount":345},"100646126","augmented-reality-icg-fluorescence-second-look-for-residual-nodal-disease-after-axillary-dissection-in-breast-cancer-100646126","NCT07696754","Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer","Mapping of Lymph Nodes Using Augmented-reality\u002FVirtual-reality Goggles in Patients With Breast Cancer","AR4SLN","Inclusion Criteria:\n\n* Histologically proven breast cancer\n* Age 18 years or older\n* Undergoing radical surgery (mastectomy or quadrantectomy) with complete axillary lymph node dissection\n* Provides written informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Neoadjuvant chemotherapy\n* Prior breast surgery\n* Iodine or seafood allergy\n* Indocyanine green (ICG) allergy\n* Declines or is unable to provide informed consent",{"count":398,"type":22},[108],"This study tests whether special imaging goggles can help surgeons find lymph nodes that may be left behind during breast cancer surgery. The goggles show a fluorescent dye (indocyanine green, ICG) that is given during the operation and collects in lymph nodes.\n\nIn breast cancer surgery, the surgeon removes lymph nodes from the armpit (axilla) to check whether the cancer has spread. Some nodes can be difficult to see and may remain after the surgeon believes the removal is complete. This study looks at whether the goggles can reveal such remaining nodes after the surgeon has declared the axillary surgery finished.\n\nThirty patients having breast cancer surgery with removal of the axillary lymph nodes will take part. After the surgeon states the planned removal is complete, the surgeon will briefly re-examine the area using the goggles and the ICG signal. If additional glowing tissue is seen, the surgeon will decide-using normal surgical judgment-whether it is safe and appropriate to remove it. Any tissue removed this way is examined under the microscope to determine whether it is a lymph node and whether it contains cancer.\n\nThe study measures how often this additional examination finds cancer-containing nodes that would otherwise have remained, where these nodes are located, whether the finding changes the cancer stage, and how much extra time the examination takes. The study also records any side effects. The results will help determine whether this approach should be studied in a larger trial.",[111,28,692,693],"Sentinel Lymph Node","Lymphatic Metastasis",[695,696,697,698,699,700,701,277],"indocyanine green","near-infrared fluorescence","fluorescence-guided surgery","augmented reality","axillary lymph node dissection","residual nodal disease","sentinel lymph node","2026-07-06",{"date":675,"type":33},{"date":675,"type":22},{"date":706,"type":22},"2027-12-31",{"name":708,"class":127},"Ss. Cyril and Methodius University of Skopje"]