A Multicenter, Randomised, Open-label Phase II Study to Evaluate the Efficacy and Safety of Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Platinum-based Neoadjuvant Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 286
- 试验地点
- 1
- 主要终点
- RFS
研究概览
简要总结
This study will evaluate the efficacy and safety of antharcycline-based adjuvant chemotherapy compared with observation in triple negative breast cancer (TNBC) patients with residual invasive disease after platinum and taxanes based neoadjuvant chemotherapy.
详细描述
This study is a multi-center, randomized, phase II study. TNBC patients with residual invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after platinum and taxanes based neoadjuvant chemotherapy are enrolled (n = 286). Patients are assigned to the chemotherapy group or the observation group at a 1:1 ratio randomly 4-6 weeks after surgery. Patients in the chemotherapy group are given anthracycline combined with cyclophosphamide regimen for 4 cycles. At the same time, the blood and tissue samples are collected for relevant tests. Follow up every 3-6 months and record recurrences and deaths.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed invasive adenocarcinoma of the breast.
- •Triple negative breast cancer: hormone receptor negative (ER < 10% and PgR < 10%) and HER2 negative (IHC 0/1+ or ISH non-amplified), as defined by the local pathology laboratory.
- •Clinical stage at presentation: T1-4, N0-3, M0, with indications for neoadjuvant chemotherapy.
- •Patient must have received platinum and taxanes neoadjuvant chemotherapy for at least 4 cycles and no tumor progression occurred.
- •Patients should have undergone adequate tumor excision in the breast and lymph nodes after neoadjuvant chemotherapy.
- •Residual invasive disease must be ≥1cm in the breast, and/or have positive axillary lymph nodes observed on pathologic exam after neoadjuvant chemotherapy.
- •ECOG Performance Status: 0-
- •Patients without severe heart, lung, liver and kidney disease.
- •Adequate hematologic and end-organ function.
- •No more than 6 weeks may elapse between definitive breast surgery and randomization.
排除标准
- •Previous neoadjuvant chemotherapy with anthracycline or other drugs (except platinum and taxanes).
- •Previous neoadjuvant chemotherapy with platinum or taxanes alone.
- •Patients have received other adjuvant therapy.
- •Comprehensive medical examinations have revealed distant metastases before randomization.
- •Patients who are not suitable for anthracycline evaluated by investigators.
- •Prior history of other malignancy (except carcinoma in situ).
研究组 & 干预措施
Adjuvant chemotherapy
Adjuvant chemotherapy for triple negative breast cancer with residual invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after taxanes and platinum based neoadjuvant chemotherapy.
Adjuvant chemotherapy regiments: Epirubicin 80-90mg/m2 IV or Pirarubicin 50mg/m2 IV + Cyclophosphamide 600mg/m2 IV, q21d*4cycles.
干预措施: Epirubicin or Pirarubicin (Drug)
Adjuvant chemotherapy
Adjuvant chemotherapy for triple negative breast cancer with residual invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after taxanes and platinum based neoadjuvant chemotherapy.
Adjuvant chemotherapy regiments: Epirubicin 80-90mg/m2 IV or Pirarubicin 50mg/m2 IV + Cyclophosphamide 600mg/m2 IV, q21d*4cycles.
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
RFS
时间窗: median 5 years
RFS defined as the time from randomization to the first recurrence event or death through the end of study
次要结局
- OS(median 5 years)
- Percentage of patients with adverse events(2-3 years)
- Changes in patient-reported quality of life(2-3 years)
研究者
Pin Zhang
Clinical Professor
Chinese Academy of Medical Sciences