A Randomized Phase III Trial of Comparing Combination Administration of Paclitaxel and Cisplatin Versus CEF as Adjuvant Chemotherapy in Breast Cancer Patients With Pathological Partial Response and Complete Response to Neoadjuvant Chemotherapy
试验速览
- 阶段
- 3 期
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
This trial will compare the administration of 2 cycles of paclitaxel and cisplatin (DP) versus 4 cycles of CEF as adjuvant chemotherapy for the patients with locally advanced breast cancer and who were pathological partial response to DP as neoadjuvant chemotherapy. Those who had pathological complete response to DP will be randomized to have 2 cycles of DP or have no further chemotherapy.
详细描述
All the patients who had neoadjuvant chemotherapy and had pathological complete response (pCR) or partial response to DP will enrolled in this trial. Those who had pCR will randmized to have two cycles of DP as adjuvant chemotherapy or have no further chemotherapy. Those patients who had PR will be randomized to have two cycles of DP or four cycles of CEF. All the patients with hormonal receptor positive or Her2 overexpress tumors are allowed to accept endocrine therapy or anti-Her2 target therapy.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥18years and ≤70 years;
- •Patients with locally advanced breast caner and had weekly paclitaxel and cisplatin as neoadjuvant chemotherapy.
- •Patients with pathological partial response or pathological complete response to neoadjuvant chemotherapy according to the Response Evaluation Criteria in Solid Tumors (RECIST).
- •Endocrine therapy and trastuzumab were allowed to use.
- •Adequate bone marrow function:WBC≥4.0×109/L, Absolute neutrophil count（ANC）≥1.5×109/L, Platelets（PLT）≥100×109/L, Hemoglobin（Hb）≥90g/L;aspartate aminotransferase(AST),Alanine aminotransferase (ALT)≤1.5 upper normal limit (UNL), creatinine≤1.5 UNL, bilirubin≤1.5UNL;
- •No obvious main organs dysfunction.
排除标准
- •Unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug;
- •Patient is pregnant or breast feeding;
- •Metastatic breast cancer;
- •Any evidence of sense or motor nerve disorders;
- •Patients with medical conditions taht indicate intolerant to neoadjuvant therapy, including uncontrolled cardiovascular disease, severe infection;
- •Any concurrent malignancy other than breast cancer;
- •Know severe hypersensitivity to any drugs in this study.
研究组 & 干预措施
Switch to CEF
Epirubicin 75 mg/m² IV push on day 1 every 3 weeks for 4 cycles. Cyclophosphamide 500 mg/m² IV push on day 1 every 3 weeks. 5-fluoruracil 500 mg/m² IV push on day 1 every 3 weeks.
干预措施: Cyclophosphamide (Drug)
Switch to CEF
Epirubicin 75 mg/m² IV push on day 1 every 3 weeks for 4 cycles. Cyclophosphamide 500 mg/m² IV push on day 1 every 3 weeks. 5-fluoruracil 500 mg/m² IV push on day 1 every 3 weeks.
干预措施: Epirubicin (Drug)
Switch to CEF
Epirubicin 75 mg/m² IV push on day 1 every 3 weeks for 4 cycles. Cyclophosphamide 500 mg/m² IV push on day 1 every 3 weeks. 5-fluoruracil 500 mg/m² IV push on day 1 every 3 weeks.
干预措施: 5-fluoruracil (Drug)
Continue the neoadjuvant regimen
Paclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 16 weeks. Cisplatin: 25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 4 cycles.
干预措施: Paclitaxel (Drug)
Continue the neoadjuvant regimen
Paclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 16 weeks. Cisplatin: 25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 4 cycles.
干预措施: Cisplatin (Drug)
Pathological complete response group with chemotherapy
Paclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 16 weeks. Cisplatin: 25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 4 cycles.
干预措施: Paclitaxel (Drug)
Pathological complete response group with chemotherapy
Paclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 16 weeks. Cisplatin: 25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 4 cycles.
干预措施: Cisplatin (Drug)
结局指标
主要结局
Disease-free survival (DFS)
时间窗: Up to 5 years
次要结局
- local recurrence free survival (LRFS)(5 years)
- overall survival (OS)(Up to 5 years)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(4 months during adjuvant therapy)
- regional recurrence free survival (RRFS)(5 years)
- distant-disease- free survival (DDFS)(5 years)
研究者
Jinsong Lu
Director of Department of Breast Surgery
RenJi Hospital