[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-breast-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,76,106],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100544469","phase-2-a-study-of-alisertib-in-combination-with-endocrine-therapy-in-patients-with-hr-positive-her2-negative-recurrent-or-metastatic-breast-cancer-100544469",false,"NCT06369285","A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer","A Phase 2 Study of Alisertib in Combination With Endocrine Therapy in Patients With HR+, HER2-negative Recurrent or Metastatic Breast Cancer","ALISCA-Breast1","Inclusion Criteria:\n\n* Aged ≥18 years at signing of informed consent.\n* Pathology-confirmed diagnosis of breast cancer with evidence of recurrent or metastatic disease not amenable to curative therapy.\n* Progression on or after treatment with at least two prior lines of endocrine therapy in the recurrent or metastatic setting. a. If metastatic disease recurrence occurs during or within six months of discontinuing adjuvant endocrine therapy, then that endocrine therapy will count as one line of prior therapy.\n* Participants must have received a CDK4\u002F6i in combination with endocrine therapy in the recurrent or metastatic setting.\n* HR-positive and HER2-negative tumor status reported per local laboratory testing. HR and HER2 testing must be performed consistent with current American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) or European Society of Medical Oncology (ESMO) guidelines.\n\nExclusion Criteria:\n\n* Treatment with chemotherapy in the recurrent or metastatic setting, including antibody drug conjugates with a chemotherapeutic payload.\n* Prior treatment with an Aurora Kinase A (AURKA) specific-targeted or pan-Aurora-targeted agent, including alisertib, in any setting.\n\nNote: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.","ALL","18 Years",{"count":20,"type":21},225,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive\u002FHER2-negative metastatic breast cancer (MBC) following progression on or after at least two prior lines of endocrine therapy in the recurrent or metastatic setting. This study is intended to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy. Participants randomized prior to Amendment 4 are randomized 1:1:1 to Arm 1, Arm 2 or Arm 3. Participants randomized under Amendment 4 will be randomized 1:1 to Arm 1 or Arm 2.",[27,28,29],"Hormone Receptor Positive HER-2 Negative Breast Cancer","Metastatic Breast Cancer","Recurrent Breast Cancer",[31,32,29,28],"Hormone receptor positive (HR+)","Human epidermal growth factor receptor 2 negative (HER2-)","RECRUITING","2026-07-24",{"date":36,"type":37},"2026-07-27","ACTUAL",{"date":39,"type":37},"2024-11-19",{"date":41,"type":21},"2029-06-30",{"name":43,"class":44},"Puma Biotechnology, Inc.","INDUSTRY",53,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100585306","phase-1-bortezomib-plus-cisplatin-in-recurrent-or-metastatic-breast-cancer-100585306","NCT06900647","Bortezomib Plus Cisplatin in Recurrent or Metastatic Breast Cancer","Phase I Study to Evaluate the Safety and Preliminary Efficacy of Bortezomib Combined With Cisplatin in Patients With Recurrent or Metastatic Breast Cancer","BOCIS","Inclusion Criteria:\n\n1. Women aged 18 years and above with pathologically confirmed recurrent or metastatic advanced breast cancer ;\n2. The patient has tumor specimens (formalin-fixed, paraffin-embedded or fresh pre-treated recurrent tumor tissue);\n3. Patients who have failed standard treatment in the late stage;\n4. At least one measurable lesion;\n5. ECOG PS : 0-2 points;\n6. Estimated survival period ≥12 weeks;\n7. The function level of major organs meets the following standards:\n\n1\\) The blood routine examination standards must meet: ANC ≥1.5×109\u002FL, PLT ≥75×109\u002FL, Hb ≥85g\u002FL (no blood transfusion and blood products within 14 days, no use of G-CSF and other hematopoietic stimulating factors for correction) 2) Biochemical examinations must meet the following standards: TBIL \\\u003C1.5×ULN, ALT, AST \\\u003C2.5×ULN, ALT, AST \\\u003C5×ULN for patients with liver metastasis, BUN and Cr ≤1×ULN or endogenous creatinine clearance ≥50ml\u002Fmin (Cockcroft-Gault formula); 8. Women of childbearing age must have taken reliable contraceptive measures, or have undergone a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and are willing to use appropriate contraceptive methods during the trial and 8 weeks after the last administration of the trial drug.\n\n9\\. The subjects voluntarily join this study, have good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\nAny of the following will be considered as meeting the exclusion criteria of the study:\n\n1. Patients with acute active hepatitis B or acute active hepatitis C;\n2. Any serious underlying disease, comorbidity and active infection\n3. Currently receiving other anti-tumor treatments;\n4. History of epilepsy or epileptic-induced condition;\n5. Patients who are pregnant or breastfeeding;\n6. Those with poor compliance or unable to undergo normal follow-up;\n7. Allergic to study drugs;\n8. Patients diagnosed with other malignant tumors within 5 years, except for the following: surgically resected non-melanoma skin cancer, adequately treated cervical carcinoma in situ, surgically radically treated ductal carcinoma in situ, or malignant tumors diagnosed 2 years ago with no current evidence of disease and untreated ≤ 2 years before randomization;\n9. The researcher determines other situations that may affect the conduct of the clinical study and the determination of the study results.","FEMALE",{"count":56,"type":21},20,[58],"PHASE1","This a phase 1 study to evaluate the safety and preliminary efficacy of cisplatin combined with bortezomib in patients with recurrent or metastatic breast cancer.",[28,29],[62,63,64],"Breast cancer","Bortezomib","Cisplatin","2025-03-27",{"date":67,"type":37},"2025-04-02",{"date":69,"type":37},"2025-01-01",{"date":71,"type":21},"2028-06-30",{"name":73,"class":74},"Sun Yat-sen University","OTHER",1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":75},"100531616","a-study-of-diffusing-alpha-radiation-therapy-for-patients-with-breast-carcinoma-in-frail-or-elderly-patients-100531616","NCT06202118","A Study of Diffusing Alpha Radiation Therapy for Patients With Breast Carcinoma in Frail or Elderly Patients.","A Pilot Feasibility and Safety Trial of Intratumoral Diffusing Alpha-emitter Radiation Therapy (DaRT) for the Treatment of Newly Diagnosed or Recurrent Breast Carcinoma in Frail or Elderly Patients.","Inclusion Criteria:\n\n* Histologically confirmed invasive breast tumor with no involvement of skin within 12 months.\n* Tumor size ≤ 4 centimeters in the longest diameter.\n* Tumor is not deemed as resectable with radical surgery or the patient does not wish to go through surgery\n* De-novo or recurrent lesions.\n* Single lesion per quadrant per subject.\n* Targeted lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds.\n* Interstitial implant indication validated by multidisciplinary team.\n* ECOG Performance Status ≤3.\n* Life expectancy ≥12 months.\n* Women Age ≥65 or younger if unfit for standard of care.\n* Willing and have the ability to provide signed Informed Consent.\n* Blood tests values:\n\n  * Leucocytes ≥3000mm3,\n  * Absolute neutrophil count ≥1500mm3,\n  * Platelets ≥100,000 mm3,\n  * Total bilirubin ≤ 1.5xULN,\n  * AST, SGOT, SGPT ≤2.5xULN, If Alkaline Phosphatase ≤ 4xULN, then transaminases are normal.\n  * Creatinine ≤ 2.0xULN.\n  * INR or Prothrombin time ≤1.5xULN\n\nExclusion Criteria:\n\n* T4 category with skin involvement.\n* Ductal carcinoma in situ.\n* Inflammatory breast carcinoma.\n* Longest tumor diameter \\>4 cm.\n* Patients with prior radiation to the same area within the past 6 months.\n* Has a known additional malignancy that is progressing or requires active treatment.\n* Patients undergoing immunosuppressive and\u002For systemic corticosteroid treatment except for steroid inhalations for treatment of asthma or lung disease\n* Subjects not willing to sign an informed consent.","65 Years","120 Years",{"count":86,"type":21},10,[88],"NA","A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of newly diagnosed or Recurrent Breast Carcinoma in frail or elderly patients.",[91,29,92],"Breast Cancer","Breast Carcinoma",[94,62,95,96],"Alpha radiation","Newly Diagnosed Breast Carcinoma","Breast carcinoma","2025-02-06",{"date":99,"type":37},"2025-02-07",{"date":101,"type":37},"2024-02-19",{"date":103,"type":21},"2026-06",{"name":105,"class":44},"Alpha Tau Medical LTD.",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":129},"100531627","phase-1-a-study-of-tqb2930-for-injection-monotherapy-or-combination-therapy-in-patients-with-recurrentmetastatic-breast-cancer-100531627","NCT06202261","A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent\u002FMetastatic Breast Cancer","A Phase Ib\u002FII Clinical Trial to Evaluate the Safety and Efficacy of TQB2930 for Injection Monotherapy or in Combination for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Recurrent \u002F Metastatic Breast Cancer","Inclusion Criteria:\n\n* Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0\\~1; The expected survival is over 3 months.\n* Phase Ib\n\n  1. Advanced malignancies confirmed by cytology \u002F histopathology, priority given to subjects with HER2 expression or amplification;\n  2. Subjects with malignant tumors who have failed standard treatment or lack effective treatment;\n  3. Confirmed presence of at least one evaluable lesion according to RECIST 1.1 criteria\n* Phase II\n\n  1. Hormone receptor (HR)-negative, HER2-positive breast cancer confirmed by cytology \u002F histopathology, with evidence of local recurrence or distant metastasis, unsuitable for surgery or radiotherapy for curative purposes:\n  2. Have not received systemic antitumor therapy for metastatic stage; Systemic use of endocrine therapy is permitted, but not exceed 2 lines;\n  3. at least one measurable lesion that meets the RECIST 1.1 criteria.\n* Major organs are functioning normally.\n* Female subjects of reproductive age should agree to use contraceptive methods during the study period and until 6 months after the end of the study; Negative serum pregnancy \u002F urine pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects; Male subjects should agree to use contraception during the study and until six months after the end of the study.\n\nExclusion Criteria:\n\n* Have occured other malignant tumors within 3 years prior to first dose.\n* Unalleviated toxicity above Common Terminology Criteria for Adverse Events (CTCAE) grade 1 due to any prior treatment;\n* Received major surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to the first dose;\n* Long-term unhealed wounds or fractures;\n* Arterial\u002Fvenous thrombosis events occurred within 6 months before the first dose;\n* Have a history of psychotropic drug abuse and can't get rid of it or have mental disorders;\n* Subject with any severe and\u002For uncontrolled disease;\n* Subjects who have been treated with other antitumor agents such as chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first dose, within 5 half-lives of the drug;\n* Have used traditional chinese medicine with anti-tumor indications approved by National Medical Products Administration (NMPA) within 2 weeks before the first dose;\n* Severe bone injury due to bone metastasis;\n* Subjects with untreated active brain metastases or meningeal metastases or cancerous meningitis;\n* In the course of previous HER2-targeted therapy, Left Ventricular Ejection Fractions (LVEF) decreased to \\\u003C50% or absolute LVEF decreased \\>15%;\n* Cumulative doses of anthracyclines exceeded doxorubicin or doxorubicin liposomes \\>360 mg\u002Fm2;\n* Uncontrolled hypercalcemia or symptomatic hypercalcemia requires continued bisphosphonate therapy\n* Patients with severe hypersensitivity after the use of monoclonal antibodies;\n* Has participated in other antitumor clinical trials within 4 weeks prior to the first dose.","75 Years",{"count":115,"type":21},154,[58,24],"This is a phase Ib\u002FII exploratory study. Phase Ib includes the dose escalation and expansion study of monotherapy, as well as the dose escalation study of combination therapy. After determining the maximum tolerated dose (MTD), a dose expansion study is conducted to observe the safety and efficacy in monotherapy. Phase II study is to further observe the safety and efficacy of TQB2930 combined with albumin-paclitaxel (cohort 3), or chemotherapy selected by investigators (cohort 4).",[28,29,119],"Advanced Malignancies","2024-03-10",{"date":122,"type":37},"2024-03-12",{"date":124,"type":37},"2023-04-13",{"date":126,"type":21},"2027-10",{"name":128,"class":44},"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.",2]