A Prospective, Multicenter Phase Ⅲ Clinical Trial of Adaptive Chemotherapy for Advanced Breast Cancer After Standard Treatment
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- progression-free survival (PFS)
研究概览
简要总结
The primary objective of this study is to explore the efficacy and safety of adaptive therapy in the treatment of advanced breast cancer progressive after standard treatment.
详细描述
This is a prospective, multicenter phase Ⅲ clinical Trial. The objective of the study is to evaluate the efficacy and safety of adaptive chemotherapy vs. conventional chemotherapy in the treatment of advanced breast cancer progressive after standard treatment. The therapy regimen, primarily including gemcitabine, vinorelbine, or eribulin, will be selected by the investigator based on current guidelines, available treatments, and an assessment of the patient's clinical status, preferences, and financial situation. This study is designed to recruit up to 192 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Understands and voluntarily signs the informed consent form.
- •ECOG PS of 0 or
- •Expected survival: >3 months
- •Histologically or cytologically confirmed advanced invasive breast cancer.
- •Histological type: HR+/HER2- or HR-/HER2-. HR positivity is defined as ER and/or PR expression in ≥1% of tumor cells by IHC. HER2 negativity is defined according to the ASCO-CAP HER2 guidelines: IHC intensity of 0 or 1+, or IHC intensity of 2+ with negative in situ hybridization results.
- •Previous failure of first-line treatment for metastatic disease. For HR+/HER2- patients: at least received endocrine therapy combined with CDK4/6 inhibitors. TNBC patients at least received chemotherapy combined with PD-1 inhibitors (if PD-L1 CPS ≥1), or PARP inhibitor treatment (if germline BRCA mutations), except for TNBC patients with known germline BRCA mutations whom the attending physician deems them unable or unsuitable for PARP inhibitor treatment.
- •At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- •Adequate organ function including bone marrow, renal function, hepatic function, and cardiac reserve.
- •Premenopausal women must use medically acceptable contraception during the study.
- •Compliance with the study protocol.
排除标准
- •The investigator considers that the presence of the following factors would be unfavorable to the subject's participation in the study or may affect protocol compliance, such as uncontrolled hypertension, persistent or active infection, etc.
- •Persistent toxicities caused by previous anti-tumor treatment that have not improved to ≤ Grade 2 or baseline levels.
- •Neoplastic spinal cord compression or active brain metastases.
- •Significant third-space fluid retention (e.g., ascites or pleural effusion).
- •Uncontrolled infection requiring treatment with intravenous antibiotic.
- •Active or uncontrolled hepatitis B or hepatitis C virus infection.
- •Uncontrolled or significant heart disease.
- •Suspected ILD/non-infectious pneumonia.
- •Active autoimmune disease or inflammatory disease (including inflammatory bowel disease.
研究组 & 干预措施
Chemotherapy repeated every 28 days
Chemotherapy regimens, including gemcitabine, vinorelbine, eribulin, or utidelone.
Gemcitabine 1000 mg/m², IV, days 1, 8; or Vinorelbine 25 mg/m², IV, days 1, 8; Vinorelbine 60-80 mg/m², Po., days 1, 8; Eribulin 1.4 mg/m², IV, days 1, 8; Utidelone 30 mg/m², IV, days 1-5; All cycles repeated every 28 days.
干预措施: Gemcitabine, Vinorelbine, Eribulin, or Utidelone (Drug)
Chemotherapy repeated every 21 days
Chemotherapy regimens, including gemcitabine, vinorelbine, eribulin, or utidelone.
Gemcitabine 1000 mg/m², IV, days 1, 8; or Vinorelbine 25 mg/m², IV, days 1, 8; Vinorelbine 60-80 mg/m², Po., days 1, 8; Eribulin 1.4 mg/m², IV, days 1, 8; Utidelone 30 mg/m², IV, days 1-5; All cycles repeated every 21 days.
干预措施: Gemcitabine, Vinorelbine, Eribulin, or Utidelone (Drug)
结局指标
主要结局
progression-free survival (PFS)
时间窗: 12 months
progression-free survival (PFS): The interval time from the date of initiation treatment after recruit to the date of the first documented disease progression or death due to any cause.
次要结局
未报告次要终点
研究者
Zhong-yu Yuan
Sun Yat-sen University Cancer Center
Sun Yat-sen University