NCT07631052招募中2 期
Capecitabine for Targeted Eradication of aRising ctDNA Molecular Residual Disease in ER+/HER2-negative Breast Cancer
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
研究概览
简要总结
This is a Phase 2 study for patients with resected Stage I-III HR+/HER2-negative breast cancer with detected molecular residual disease (MRD+) following standard neo/adjuvant 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients ≥ 18 years of age with histologically confirmed (by local assessment with ASCO/CAP criteria), resected ER-positive/HER2-negative stage I-III breast cancer
- •Evidence of MRD (positive test by the Pathlight assay) despite standard adjuvant therapy
- •No contraindications to capecitabine (including absence of DPYD variants that in the opinion of the investigator are a contraindication to metronomic capecitabine)
- •No clinical or radiographic evidence of recurrent or metastatic disease
- •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 CDK4/6i if indicated, unless not tolerated or declined
- •ECOG performance status of 0-
- •Patient must have adequate organ function as determined by the following:
- •a. Renal function:
- •Serum creatinine < 1.5 x ULN (upper limit of normal range) or a calculated creatinine clearance of > 50mL/min using the Cockcroft-Gault formula
- •b. Bone marrow function (without hematopoietic growth factors or transfusion):
- •Absolute neutrophil count (ANC) > 1.0 x 109/L
- •Hemoglobin > 90 g/L or > 9g/dL
- •Platelets > 75 x 109/L
- •c. Liver function:
- •Total bilirubin ≤ 1.5 × ULN and < 35 uMol/L; OR total bilirubin >1.5 × ULN with indirect bilirubin < 1.5 × ULN.
- •Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) < 2.5 x ULN.
- •Female participants of childbearing potential must have a negative serum β-HCG test result at enrolment.
- •Female participants of childbearing potential must agree to use methods of contraception that are highly effective.
- •Male participants must agree to use methods of contraception that are highly effective.
- •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.
- •Signed written and voluntary informed consent.
排除标准
- •Prior therapy with capecitabine.
- •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.
- •Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following:
- •History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) <6 months prior to screening,
- •Symptomatic chronic heart failure (e.g., New York Heart Association Class ≥ 2), history or current evidence of clinically significant cardiac arrhythmia and/or conduction abnormality <6 months prior to screening except atrial fibrillation and paroxysmal supraventricular tachycardia.
- •Uncontrolled hypertension defined as persistent elevation of systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100mmHg, despite current therapy.
- •Known positive serology for HIV (Human immunodeficiency virus) that is not currently controlled with antiretroviral therapy.
- •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.
- •Impaired gastrointestinal function or disease that may significantly alter the absorption of capecitabine.
- •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.
研究组 & 干预措施
Capecitabine
Experimental
Capecitabine 500 mg
干预措施: Capecitabine (Drug)
研究者
研究点 (1)
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