A Phase ll Trial of Impact of Additional 4 Cycles of Cisplatin (CDDP4) in Patients With Triple Negative Breast Cancer Not Achieving Clinical CR After 4 Cycles of Neoadjuvant Adriamycin Plus Cyclophosphamide
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- pathologic complete response (pCR) rate
研究概览
简要总结
Achievement of pathologic complete response is important prognosticator to predict long term outcome in triple negative cancer. The efficacy of adding 4 cycles of cisplatin (CDDP4) is to be investigated whether addtional pathologic complete response is achieved for those triple negative breast cancer patients who recieved 4 cycles of adriamycin with cyclophosphamide(AC4) but did not reach clinical complete response during the course of neoadjuvant therapy.
详细描述
First outcome measures (analysis) :at the time of surgery,
Second outcome measures:
2019 August, 5 year Overall Survival, Disease free survival
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically proven breast cancer
- •Age, at least 20 years
- •ER/PR/HER2 (negative/negative/negative
- •ER/PR negative: nuclear reaction < 1%, Allred score 0 or 2
- •HER2 negative: HER2; IHC (immunohistochemistry) 0,1+ or FISH/SISH (-) in case of IHC 2+
- •Clinically stage II or III with histologically proven lymph-node involvement (T >1.5 cm or lymph node [LN] >1.5 cm)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •No prior hormonal treatment, chemotherapy or radiotherapy is allowed.
- •Adequate hematologic, liver and kidney function
- •Written informed consent
排除标准
- •Pregnancy or lactation
- •Prior chemotherapy or radiotherapy for any malignancy
- •Stage T4d; inflammatory breast cancer
- •No primary tumor (T0)
- •Documented history of cardiac disease contraindicating anthracyclines
- •Currently active infection
研究组 & 干预措施
adriamycin,cytoxan, cisplatin
4 cycles of Adriamycin 60 mg/m2 and Cyclophosphamide 600 mg/m2 every 3 weeks followed by 4 cycles of cisplatin 75 mg/m2 every 3 weeks
干预措施: AC4-CDDP4 (Drug)
结局指标
主要结局
pathologic complete response (pCR) rate
时间窗: up to 36 weeks
Rate of pCR (as defined by NSABP \[National Surgical Adjuvant Breast and Bowel Project\] criteria - absence of invasive disease in the breast \[ypT0\]) at the time of surgery.
次要结局
- 3 year disease free survival (3yr-DFS)(3 years)
- Complete metabolic response (CMR) rate after 2 cycles of AC(up to 12 weeks)
- Rate of breast conservation(up to 36 weeks)
- Overall response rate (ORR) by radiologic evaluation(up to 36 weeks)
研究者
Sung-Bae Kim
Professor
Asan Medical Center