[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-invasive-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-invasive-breast-cancer":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,73,109],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100650844","diagnostic-prediction-model-for-de-novo-metastatic-breast-cancer-100650844",false,"NCT07752238","Diagnostic Prediction Model for De Novo Metastatic Breast Cancer","Development of a Diagnostic Prediction Model for de Novo Metastatic Breast Cancer Using Routinely Available Baseline Parameters","Inclusion Criteria:\n\n* Female sex, aged 18 years or older.\n* Newly diagnosed invasive breast cancer.\n* Case reviewed by the Multidisciplinary Tumour Board at the study site during the inclusion period (between October 1, 2018, and July 31, 2025).\n* No history of prior or synchronous invasive malignancies, except for synchronous bilateral breast cancer.\n* Intent for primary treatment and clinical management at the study site.\n* Availability of longitudinal clinical records throughout the 12-month follow-up period or until death.\n\nExclusion Criteria:\n\n-Absence of baseline systemic staging.","FEMALE","18 Years",{"count":19,"type":20},925,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to create a tool to estimate the risk of macroscopic distant tumor spread in women with newly diagnosed breast cancer. The main question it aims to answer is:\n\n• Can a model, which combines routine medical information collected at diagnosis, accurately predict if a patient has metastasis large enough to be found during systemic imaging? Researchers will review the past medical records of participants who were treated at a university hospital. Because this study looks at past data, participants will not be asked to do any new tasks, take new tests, or change their medical care.",[24,25],"Breast Cancer","Metastatic Invasive Breast Cancer",[27,28,29],"de novo metastasis","breast cancer","predictive modelling","RECRUITING","2026-08-10",{"date":33,"type":34},"2026-08-12","ACTUAL",{"date":31,"type":34},{"date":37,"type":20},"2027-02-28",{"name":39,"class":40},"Markusovszky University Teaching Hospital os County Vas","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":41},"100611241","promoting-active-living-among-people-with-metastatic-breast-cancer-100611241","NCT07238023","Promoting Active Living Among People With Metastatic Breast Cancer","Testing the Feasibility and Acceptability of a Remotely Delivered Program to Promote Active Living Among People With Metastatic Breast Cancer","Inclusion Criteria:\n\n* having been diagnosed with metastatic breast cancer\n* medical clearance from healthcare provider to participate in this study\n* life expectancy of at least 6 months as per the participant's healthcare provider\n* Eastern Cooperative Oncology Group performance status of or 0 or 1\n* being willing and able to use a smartphone and web interface with or without assistance; if assistance is needed, it must be readily available\n* adequate visual and hearing acuity to use a smartphone and web interface as indicated by self-report\n* adequate motor capacity to use a smartphone and web interface as indicated by self-report\n* willingness to download and use study-specific app(s), the Fitbit mobile application (this requires use of a Google Gmail account), and other mobile applications for study purposes as needed\n* completed baseline survey\n\nExclusion Criteria:\n\n* contraindications to physical activity (e.g., uncontrolled hypertension or cardiac disease noted by the patient's treating healthcare provider)\n* presence of bone metastases deemed unstable by the treating healthcare provider.\n* untreated brain metastases\n* history of dementia or other major neurocognitive disorder\n* received a diagnosed of Major Depressive Disorder within the previous 6 months\n* received a diagnosis of a major psychiatric conditions such as bipolar disorder, psychosis, schizophrenia, or alcoholism that could affect the ability to understand and\u002For complete the study\n* currently hospitalized\n* enrolled in hospice\n* inability to speak, read, and write in English at the 7th grade level","ALL","99 Years",{"count":52,"type":20},38,"INTERVENTIONAL",[55],"NA","Individuals with metastatic breast cancer are living longer but often face persistent fatigue, functional decline, and psychological distress. Physical activity is generally safe for this population and may alleviate symptom burden. Yet, limited interventions are tailored to the unique and needs and preferences of this population. This study aims to evaluate the acceptability and feasibility of a mindfulness- and acceptance-based physical activity program designed to support mental, social, and spiritual well-being among people with metastatic breast cancer. A single group, pretest-posttest trial (N=38) will be conducted to inform scalable strategies to promote active living and enhance quality of life among people with advanced cancer.",[25],[59,60,61,62,63],"aerobic physical activity","muscle strengthening physical activity","mindfulness","acceptance","telehealth","2026-07-28",{"date":66,"type":34},"2026-07-30",{"date":68,"type":34},"2026-02-27",{"date":70,"type":20},"2026-12",{"name":72,"class":40},"University of Oklahoma",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":53,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":41},"100648914","phase-2-neu-direction-testing-the-efficacy-of-adding-her-inhibition-to-standard-of-care-in-metastatic-mlh1-low-endocrine-resistant-erher2--breast-cancer-100648914","NCT07729046","Neu Direction: Testing the Efficacy of Adding HER Inhibition to Standard of Care in Metastatic MLH1-low Endocrine-resistant ER+\u002FHER2- Breast Cancer","Neu Direction: A Single Center Phase II Randomized Clinical Trial to Assess the Efficacy of Adding HER Inhibition to Standard of Care in Patients With Metastatic MLH1-low Endocrine-resistant ER+\u002FHER2- Breast Cancer","Inclusion Criteria:\n\n1. Female over the age of 18 at the time of study enrollment\n2. Not pregnant, planning to become pregnant or breast feeding\n3. Metastatic ER+\u002FHER2- breast cancer that has progressed on 1st line therapy including endocrine therapy +\u002F- CDK4\u002F6 inhibitors\n4. At least one metastatic lesion visible on imaging (including FDG-PET)\n5. At least one metastatic lesion must be biopsied and confirmed ER+ and HER2- by immunohistochemistry within 6 months of study screening (HER2 equivocal disease will be confirmed HER2- by FISH)\n6. Tumors must be MLH1-low defined by \\\u003C50% tumor cells positive for nuclear MLH1 expression on immunohistochemistry\n7. Standard of care next line endocrine therapy can include any endocrine therapy\n8. Performance status ECOG \\> 3\n9. Life expectancy \\> 1 year\n10. Ability to get serial imaging studies\n\nExclusion Criteria:\n\n1. History of concurrent use of other HER2-targeted therapy\n2. Concurrent use of other targeted systemic therapy\n3. History of other cancers other than non-melanoma skin cancer\n4. Actionable mutations on tumor genomic sequencing will be ineligible, and those participants encouraged to proceed with the relevant targeted therapy\n5. Participants where there is not at least one imaging apparent lesion that has not been treated with prior targeted therapy (for example palliative radiation or cryoablation)\n6. Contraindications to Neratinib use including allergy or hypersensitivity\n7. Baseline grade 3+ diarrhea",{"count":81,"type":20},150,[83],"PHASE2","The goal of this clinical trial is to learn if neratinib, an FDA-approved oral pan-HER2\u002F3\u002F4 inhibitor, improves disease control for participants with metastatic endocrine-resistant ER+\u002FHER2-negative breast cancer. Neratinib is already approved for the treatment of HER2-postive breast cancers. The study will also learn about the safety of adding this drug to standard of care treatments. The main questions it aims to answer are:\n\n1. Does adding neratinib to standard of care systemic therapy improve disease control for patients with metastatic hormone-driven breast cancer that is resistant to endocrine therapy?\n2. What side effects do participants have when adding neratinib to standard of care therapy? Researchers will compare standard of care endocrine therapy regimens with and without neratinib to see if neratinib improves control of treatment-resistant metastatic breast cancer that has continued to progress while eon first line endocrine therapy.\n\nParticipants will:\n\n1. Take standard of care endocrine therapy for metastatic endocrine-resistant breast cancer as determined by their medical oncologist or standard of care therapy with neratinib daily\n2. Visit the clinic every 3 months for checkups, tests and imaging studies",[25,86,87],"Resistant Breast Cancer","ER+, HER2-, Metastatic Breast Cancer",[89,90,91,92,93,94,95,96,97,98],"endocrine-resistant","DNA mismatch repair","MLH1","dMMR","metastatic breast cancer","ER+ breast cancer","endocrine-resistance","HER2 negative","HER2-","neratinib","NOT_YET_RECRUITING","2026-07-22",{"date":102,"type":34},"2026-07-27",{"date":104,"type":20},"2027-07",{"date":106,"type":20},"2035-06",{"name":108,"class":40},"University of California, San Diego",{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":53,"phases":119,"briefSummary":121,"conditions":122,"keywords":123,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":4},"100648088","phase-3-rising-ctdna-to-tailor-endocrine-therapy-switch-in-patients-with-erher2--metastatic-breast-cancer-100648088","NCT07717450","Rising ctDNA to Tailor Endocrine Therapy Switch in Patients With ER+\u002FHER2- Metastatic Breast Cancer.","TAILORswitch (PADA-2): Rising ctDNA to Tailor Endocrine Therapy Switch in Patients With ER+\u002FHER2- Metastatic Breast Cancer.","TAILORswitch","Inclusion Criteria:\n\nRelated to Step #1\n\n1. First written informed consent (ICF#1) prior to any trial specific procedures. When the participant is physically unable to give his written consent, an impartial witness, independent from the investigator and the sponsor, can confirm in signing the participant's consent;\n2. Men or women ≥ 18 years of age;\n3. Eastern Cooperative Oncology Group performance status of 0 or 1;\n4. ER+ HER2- advanced (metastatic or locally advanced inoperable) breast adenocarcinoma (ER-positivity threshold: ≥10% tumor cells; HER2-negative tumour is defined as an immunohistochemical (IHC) score of 0 or 1+, or an IHC score of 2+ with negative in situ hybridization (ISH) (HER2\u002FCEP17 ratio \\\u003C2 or, for single probe assessment, HER2 copy number \\\u003C4, according to the most recent available results), not amenable to resection or radiation therapy with curative intent;\n5. Eligible to (per investigator assessment) or currently receiving for up to 3 years, AI (+\u002F- LH-RH agonist) and CDK4\u002F6i (palbociclib or ribociclib) as first line therapy with adequate cardiac, renal, hematological and hepatic functions per investigator assessment;\n6. Evaluable disease (RECIST v1.1) before the start of AI+CDK4\u002F6i and, in participants currently receiving AI and CDK4\u002F6i, no evidence of clinical or radiological progression since AI+CDK4\u002F6i initiation;\n7. Must have an adequate archival tumor tissue sample available (with a cellularity \\> 30%) for centralized WGS analysis to design the ctDNA test. Requirements:\n8. Pre\u002Fperimenopausal women and fertile men must agree to use adequate contraception methods during the study:\n\n   * Female participants must be using highly effective standard-of-care non-hormonal contraceptive measures from the time of screening until 3 weeks after exiting from Step #1 (a highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly); or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening: (a) Post-menopausal, defined as women with: (i) Cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; (ii) Cessation of regular menses for at least 6 consecutive months with no alternative pathological or physiological cause AND with serum estradiol and follicle stimulating hormone level within the laboratory's reference range for post-menopausal females; (iii) Previous bilateral surgical oophorectomy.\n   * Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile or using an acceptable method of contraception until at least one week after the last treatment administration.\n9. Women of childbearing potential must have a negative serum or urine pregnancy test done within 28 days before inclusion;\n10. Minimum life expectancy of at least 6 months;\n11. Participants must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan and other study procedures including follow-up;\n12. Participants must be affiliated with a social security scheme or a beneficiary of such a scheme (or equivalent);\n\n    Additional criteria to be part of the imaging de-escalation sub-study in Step #1:\n13. Additional written informed consent (ICF#2). When the participant is physically unable to give his written consent, an impartial witness, independent from the investigator and the sponsor, can confirm in signing the participant's consent;\n14. Participants must have received at least 6 months (from 22 weeks authorized) of treatment with AI + CDK4\u002F6 inhibitor, with no evidence of ctDNA rising in STEP #1 (at the current visit or, if current results are pending, at the previous visit), and no disease progression on imaging at the current visit as per RECIST v1.1.\n15. ctDNA detected at study entry and no rising ctDNA;\n16. No history of venous thrombo-embolic event, interstitial lung disease or any pre-existing condition that may impair participant's respiratory function (per investigator assessment);\n17. Willingness and ability to comply with scheduled visits;\n\n    Related to Step #2:\n18. Additional written informed consent (ICF#3). When the participant is physically unable to give his written consent, an impartial witness independent from the investigator and the sponsor, can confirm in signing the participant's consent;\n19. Rising ctDNA (as defined in the protocol) detected during Step #1 (centrally determined);\n20. Having received at least 6 months of AI + CDK4\u002F6i;\n21. Adequate bone marrow reserve and organ function as follows:\n\n    1. Hemoglobin ≥9.0g\u002FdL (90 g\u002FL).\n    2. Absolute neutrophil count ≥1000\u002Fmm3 (1.0×10\\^9\u002FL) or documented institutional normal range for starting abemaciclib.\n    3. Total bilirubin ≤1.5×ULN or ≤3×ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia).\n    4. ALT and AST ≤3×ULN; for participants with hepatic metastases, ALT and AST ≤5×ULN.\n    5. Alkaline phosphatase ≤2.5×ULN (≤ 5.0×ULN if bone or liver metastases present).\n    6. Serum creatinine ≤ 1.5×ULN or calculated creatinine clearance ≥ 30 mL\u002Fmin as determined by Cockcroft-Gault (using actual body weight).\n22. Female participants must have a negative highly sensitive serum pregnancy test during the screening period if they are of childbearing potential and agree to use highly effective contraceptive methods to prevent pregnancy during the study and for 4 weeks following the last dose of camizestrant (if applicable) and\u002For for 3 weeks after the last dose of CDK4\u002F6inhibitor or must have evidence of nonchildbearing potential. In addition, female participants must refrain from egg cell donation and breastfeeding during this same period.\n\n    1. Non-sterilized male partners of a participant who is a woman of childbearing potential must use a male condom plus spermicide from the time of screening throughout the total duration of the study until 4 weeks after last dose of camizestrant.\n    2. Non-sterilised male participants (including males sterilised by a method other than bilateral orchidectomy, eg, vasectomy) who intend to be sexually active with a Female Of ChildBearing Potential (FOCBP) must be using an acceptable method of contraception, such as male condom plus spermicide (condom alone in countries where spermicides are not approved), from enrolment throughout the study until at least 1 week to avoid conception during treatment. Male participants must not donate or bank sperm during this same period.\n    3. Female partners (of child-bearing potential) of male participants enrolled in this study must also use a highly effective method of contraception from the time of study enrolment of their male partner, throughout their participation in the study, and until at least 1 week after their male partners last dose of camizestrant.\n\nExclusion Criteria:\n\nRelated to step #1:\n\n1. Systemic antineoplastic therapy (except adjuvant therapies) received prior to AI and CDK4\u002F6i;\n2. Known leptomeningeal metastasis and\u002For brain metastasis;\n3. Known contraindication to camizestrant and abemaciclib, per investigator assessment;\n4. Prior exposure to camizestrant, other SERD or investigational endocrine therapy agents;\n5. History of another malignancy, except (i) those treated with curative intent and with no known active disease ≥3 years; (ii) adequately treated non-melanoma cutaneous and in-situ cervix cancer;\n6. History of bone marrow transplantation;\n7. Patients relapsing while on or during the year after the discontinuation of adjuvant CDK4\u002F6 inhibitor.\n8. Pregnant women or women who are breast-feeding or participants not willing to apply highly effective contraception as defined in the protocol;\n9. Participants unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons;\n10. Participation in another clinical study whose procedures interfere with those of the study (within 28 days prior to participant enrolment and for the duration of the study);\n11. Persons deprived of their liberty or under protective custody or guardianship;\n\n    Related to step #2:\n12. Participants with synchronous disease progression per local assessment (tumor imaging performed within 28 days prior to entry in Step #2 RECIST v1.1);\n13. Participants with a contraindication to abemaciclib, as assessed by the investigator;\n14. Participants presenting any cardiovascular conditions (as described in the protocol)\n15. Participants treated within the last 2 weeks before randomization with medications that are sensitive substrates (e.g. omeprazole) or substrates with narrow therapeutic index of CYP2C9 and\u002For CYP2C19 (e.g. warfarin and phenytoin). Strong CYP3A4\u002F5 inducers should be stopped at least 2 weeks before randomization (3 weeks for St John's Wort).\n16. Participant who was treated within the timeframe indicated in the CSP with drugs that are known to prolong the QT interval.\n17. Participant taking medications known to prolong the QT interval and associated with a known risk of Torsades de Pointes\n18. Participant with a known active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), HBV (known positive HBsAg result), and HCV. Participants with past HBV infection or resolved HBV infection (defined as having a negative hepatitis B surface antigen \\[HBsAg\\] test and a positive hepatitis B core antibody \\[HBcAb\\] test, accompanied by a negative HBV DNA test) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA\n19. Participants known to be positive for HIV can be enrolled if they fulfil the criteria recommended by Food and Drug Administration (FDA) and ASCO guidelines (FDA Guidance, Uldrick et al 2017): CD4+ T-cell (CD4+) counts ≥350 cells\u002FµL, AND No history of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections within the past 12 months (prophylactic antimicrobials allowed if no DDI or overlapping toxicities), AND On established anti-retroviral therapy (ART) for at least 4 weeks and have an HIV viral load less than 400 copies\u002FmL before enrolment. Effective ART is defined as a drug, dosage and schedule associated with reduction and control of the viral load",{"count":118,"type":20},370,[120],"PHASE3","Rationale:\n\nIn patients with metastatic breast cancer, fragments of tumor DNA called \"circulating tumor DNA\" or \"ctDNA\" can be detected in the blood. When the level of ctDNA increases, it often means that treatment is no longer effective and that the disease is likely to progress. Previous studies have shown that quickly changing hormone therapy as soon as a specific genetic anomaly (ESR1 mutation) is detected in the blood can improve outcomes for breast cancer patients. This monitoring also allows for earlier action against cells that are resistant to treatment. However, this mutation is only present in about 4 out of 10 women, which limits the use of this method to only some patients.\n\nUnlike previous approaches that targeted only the ESR1 mutation, the TAILORswitch study will assess a change in treatment following an increase in ctDNA, even in the absence of mutation, and before any other signs of disease progression. This change will include a new oral hormone therapy (camizestrant) combined with a targeted treatment that has shown benefits in cases of resistance (abemaciclib). This approach aims to intervene earlier in order to prevent disease progression.\n\nIn summary, TAILORswitch explores a new way to personalize treatment, using more sensitive blood monitoring tools to improve quality of life and patient outcomes.\n\nObjectives:\n\nThe primary objective of this trial is to demonstrate the efficacy of switching to camizestrant-abemaciclib combination therapy in patients with hormone-dependent metastatic breast cancer (ER+ HER2-) receiving targeted therapy combined with hormone therapy as first-line treatment, in cases where ctDNA levels increase without other signs of disease progression (clinical or radiological).\n\nSecondary objectives include:\n\n* The efficacy, safety, and tolerability of the treatment switch\n* The safety and feasibility of reducing the number of imaging exams in patients undergoing ctDNA monitoring every 3 months (optional substudy).\n\nTrial Design:\n\nTAILORswitch is a multi-step phase 3 randomized trial. Step 1 involves recruiting 370 patients with advanced or metastatic hormone-dependent breast cancer who are receiving CDK4\u002F6 inhibitor and aromatase inhibitor therapy as their first treatment.\n\nOptional: some patients included in Step 1 will be offered to participate in a sub-study to evaluate imaging follow-up de-escalation. These patients will be allocated in of the following groups:\n\n* Group A: maintenance of standard imaging every 3 to 4 months.\n* Group B: reduction to imaging once per year at most, with a return to the standard frequency in case of clinical, radiological, biological, or ctDNA-based signs of progression.\n\nStep 2 involves patients who are initially eligible and show an increase in ctDNA levels without radiological progression. These patients will be allocated to one of the following groups:\n\n* Group experimental: switch to the combination of camizestrant + abemaciclib until progression.\n* Group control: continuation of standard treatment (AI + CDK4\u002F6i) until progression.\n\nThe recruitment period is 30 months, with the aim of including 156 patients in Step 2. Each participant will be followed for 30 months after inclusion.",[25],[124,125,126,127,93],"ctDNA monitoring","ER+ HER2- advanced breast cancer","de-escalate serial tumor imaging","watch and switch","2026-07-16",{"date":130,"type":34},"2026-07-21",{"date":132,"type":20},"2026-09-25",{"date":134,"type":20},"2032-06-25",{"name":136,"class":40},"UNICANCER"]