[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"er-positive-her2-negative-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:er-positive-her2-negative-breast-cancer":80},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100642722","phase-2-capecitabine-in-erher2-negative-breast-cancer-100642722",false,"NCT07631052","Capecitabine in ER+\u002FHER2-negative Breast Cancer","Capecitabine for Targeted Eradication of aRising ctDNA Molecular Residual Disease in ER+\u002FHER2-negative Breast Cancer","Inclusion Criteria:\n\n* Male or female patients ≥ 18 years of age with histologically confirmed (by local assessment with ASCO\u002FCAP criteria), resected ER-positive\u002FHER2-negative stage I-III breast cancer\n* Evidence of MRD (positive test by the Pathlight assay) despite standard adjuvant therapy\n* No contraindications to capecitabine (including absence of DPYD variants that in the opinion of the investigator are a contraindication to metronomic capecitabine)\n* No clinical or radiographic evidence of recurrent or metastatic disease\n* Previous Therapy requirements: (i) Received at least 24 months of adjuvant endocrine therapy, including 6 months of an aromatase inhibitor and (i) Received at least 12 months of adjuvant CDK4\u002F6i if indicated, unless not tolerated or declined\n* ECOG performance status of 0-1.\n* Patient must have adequate organ function as determined by the following:\n\n  a. Renal function:\n* Serum creatinine \\\u003C 1.5 x ULN (upper limit of normal range) or a calculated creatinine clearance of \\> 50mL\u002Fmin using the Cockcroft-Gault formula\n\n  b. Bone marrow function (without hematopoietic growth factors or transfusion):\n* Absolute neutrophil count (ANC) \\> 1.0 x 109\u002FL\n* Hemoglobin \\> 90 g\u002FL or \\> 9g\u002FdL\n* Platelets \\> 75 x 109\u002FL\n\n  c. Liver function:\n* Total bilirubin ≤ 1.5 × ULN and \\\u003C 35 uMol\u002FL; OR total bilirubin \\>1.5 × ULN with indirect bilirubin \\\u003C 1.5 × ULN.\n* Aspartate aminotransferase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) \\\u003C 2.5 x ULN.\n* Female participants of childbearing potential must have a negative serum β-HCG test result at enrolment.\n* Female participants of childbearing potential must agree to use methods of contraception that are highly effective.\n* Male participants must agree to use methods of contraception that are highly effective.\n* The participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n* Signed written and voluntary informed consent.\n\nExclusion Criteria:\n\n* Prior therapy with capecitabine.\n* Previous or concurrent malignancy within 3 years of study entry, with the following exceptions: adequately treated basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, or other non-invasive or indolent malignancy; other solid tumors treated curatively without evidence of recurrence for at least 3 years prior to study entry.\n* Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following:\n\n  1. History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) \\\u003C6 months prior to screening,\n  2. Symptomatic chronic heart failure (e.g., New York Heart Association Class ≥ 2), history or current evidence of clinically significant cardiac arrhythmia and\u002For conduction abnormality \\\u003C6 months prior to screening except atrial fibrillation and paroxysmal supraventricular tachycardia.\n  3. Uncontrolled hypertension defined as persistent elevation of systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100mmHg, despite current therapy.\n* Known positive serology for HIV (Human immunodeficiency virus) that is not currently controlled with antiretroviral therapy.\n* Has a known history of or is positive for active hepatitis B or hepatitis C unless adequate viral suppression is achieved. Participants who have had definitive treatment for HCV are permitted if HCV RNA is undetectable at Screening Visit.\n* Impaired gastrointestinal function or disease that may significantly alter the absorption of capecitabine.\n* Medical, psychiatric, cognitive, or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol, or complete the study.","ALL","18 Years",{"count":19,"type":20},15,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a Phase 2 study for patients with resected Stage I-III HR+\u002FHER2-negative breast cancer with detected molecular residual disease (MRD+) following standard neo\u002Fadjuvant and locoregional therapy delivered with curative intent. In this study participants will be treated with capecitabine. Capecitabine will be administered orally at a dose of 500 mg 3 times daily for up to 12 months, or until the time of clinical recurrence, discontinuation due to toxicity, or withdrawal of consent. This study will have two stages, stage 1 would enroll up to 8 participants to clear the Minimal Residual Disease (MRD) and Stage 2 will enroll up to 5 participants. The purpose of this study is to determine if this study population would have a better outcome from receiving capecitabine rather than having no change in treatment if MRD is detected.",[26,27,28,29],"ER-positive, HER2-negative Breast Cancer","Breast Cancer Stage I","Breast Cancer Stage II","Breast Cancer Stage III","RECRUITING","2026-06-09",{"date":33,"type":34},"2026-06-11","ACTUAL",{"date":36,"type":20},"2026-06-30",{"date":38,"type":20},"2029-08-01",{"name":40,"class":41},"University Health Network, Toronto","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100642669","phase-3-a-phase-iiib-study-to-evaluate-camizestrant-plus-ribociclib-in-er-positive-her2-negative-advanced-breast-cancer-100642669","NCT07647328","A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer","SERAFA-1: A Single Arm, Open Label, Multicentre, Phase IIIb Study Of Camizestrant Plus Ribociclib in 1st Line Treatment of ER Positive, HER2-negative Advanced Breast Cancer Patients","SERAFA-1","Inclusion Criteria:\n\n1. Capable of giving signed informed consent.\n2. Female or male, must be ≥ 18 years or as per locally allowed age limit for screening.\n\n   Type of Participant and Disease Characteristics\n3. Histologically or cytologically documented diagnosis of ER+, HER2- BC based on local laboratory results and who are not amenable to resection or radiation therapy with curative intent.\n4. Previously untreated with any systemic anti-cancer therapy for their locoregionally recurrent or metastatic ER+ disease.\n5. De novo Stage 4 disease, or recurrence from early CD stage breast cancer after having received standard adjuvant endocrine therapy. Note that at least 12 months must have elapsed since the patient's last dose of adjuvant AI therapy without disease progression on treatment. Note that a 2-week washout period is required after the last dose of tamoxifen prior to randomisation.\n6. ECOG performance status of 0 or 1.\n7. Adequate organ and marrow function. Sex and Contraceptive\u002FBarrier Requirements\n8. For those female or male patients who are not abstinent (in line with their preferred and usual lifestyle choice), and intend to be heterosexually active with a partner:\n\nFemale patients must be using highly effective contraceptive measures from the time of screening until 4 weeks after discontinuation of study treatment, and must have a negative serum pregnancy test before first dose of any study treatment if they are of childbearing potential; or must have evidence of nonchild-bearing potential by fulfilling one of the following criteria at screening:\n\n(a) Post-menopausal, defined as women with cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause: (i) Age ≥ 60 years (ii) Age \\\u003C 60 years with serum estradiol and FSH level within the laboratory's reference range for post-menopausal females (iii) Previous bilateral surgical oophorectomy (iv) Medically confirmed ovarian failure OR (b) Pre\u002Fperi-menopausal, ie, not meeting the criteria for being post-menopausal.\n\n(i) Pre-\u002Fperi-menopausal women can be enrolled if amenable to be treated with monthly LHRH agonists (goserelin or leuprorelin \\[also known as leuprolide\\]). Patients must have concomitant treatment with LHRH agonists (goserelin or leuprorelin \\[leuprolide\\]) before or on the same day as the first dose of study treatment - and must be willing to continue on it for the duration of the study.\n\nNon sterilised male partners of a patient who is a woman of childbearing potential must use a male condom plus spermicide (condom alone in countries where spermicides are not approved) throughout this period.\n\nMale 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 from the time of screening throughout the total duration of the programme and the drug washout period to prevent pregnancy in a partner. Male participants must not donate or bank sperm during this same time period.\n\nMale patients can be enrolled if amenable to be treated with monthly LHRH agonists (goserelin or leuprorelin \\[also known as leuprolide\\]) unless the patients have clear orchiectomy medical history. Willingness to use 2 non-hormonal based methods of contraception throughout the study.\n\nExclusion Criteria:\n\n1. Participants who are not clinically indicated for endocrine therapy in combination with the CDK4\u002F6 inhibitor ribociclib.\n2. No evidence of advanced inoperable disease, or bone only disease with sclerotic\u002Fosteoblastic bone lesions only per standard of care imaging.\n3. Have advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term, and\u002For pulmonary lymphangitis.\n4. Persistent treatment-induced non-haematological toxicities (CTCAE Grade \\> 2).\n5. Known active infection including tuberculosis HBV and HCV.\n6. Known to have tested positive for HIV. Participants with HIV may be enrolled if they fulfil the criteria recommended by FDA and ASCO guidelines.\n7. Any clinically important abnormalities in heart conduction patterns; participants with pacemakers or medically controlled atrial fibrillation are not excluded.\n8. Ongoing symptomatic hypotension.\n9. Pregnant or lactating women or patients not willing to use highly effective contraception as defined in the protocol.","130 Years",{"count":53,"type":20},150,[55],"PHASE3","The purpose of this study is to investigate the efficacy, safety, and tolerability of camizestrant in combination with ribociclib in patients with ER+ HER2- BC who have not received any other systemic treatment for advanced disease. Participants will be treated within the trial until they discontinue the study treatment for any reason.",[58],"ER-Positive HER2-Negative Breast Cancer",[60,61,62,63,64,65,66,67,68],"Metastatic","Breast Neoplasms","Neoplasms by Site","Neoplasms","Breast Diseases","Next Generation Oral SERD","Antineoplastic Agents","Estrogen Receptor Antagonists","Camizestrant","NOT_YET_RECRUITING",{"date":71,"type":34},"2026-06-15",{"date":73,"type":20},"2026-05-26",{"date":75,"type":20},"2034-04-10",{"name":77,"class":78},"AstraZeneca","INDUSTRY",80,"ER Positive, HER2 Negative Breast Cancer"]