A Randomized, Phase 2 Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 37
- 主要终点
- Number of Participants With Pathologic Complete Response (pCR) (Rate of pCR)
研究概览
简要总结
To demonstrate whether addition of MM-121 to paclitaxel is more effective than treatment with paclitaxel alone, when administered as part of the neoadjuvant treatment in Her2 negative locally advanced operable breast cancer patients.
详细描述
This is a multicenter, open-label, randomized, Phase II study of preoperative MM-121 with paclitaxel in HER2-negative breast cancer. Patients will be randomized to receive paclitaxel with or without MM-121 for 12 weeks followed by 4 cycles of doxorubicin plus cyclophosphamide and subsequent surgery.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histological confirmation of ER positive, HER2 negative invasive breast cancer (Group 1) or invasive triple-negative breast cancer (Group 2)
- •Free of metastatic disease
- •≥ 18 years old
- •Had no prior treatment for any cancer
- •Eligible for treatment with paclitaxel, doxorubicin and cyclophosphamide
排除标准
- •Have a history of severe allergic reactions to paclitaxel or other drugs formulated in Cremaphor® EL
- •Are pregnant or breastfeeding
研究组 & 干预措施
MM-121 (SAR256212) + paclitaxel
2 week run-in of MM-121 followed by MM-121 + dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
干预措施: MM-121 (Drug)
MM-121 (SAR256212) + paclitaxel
2 week run-in of MM-121 followed by MM-121 + dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
干预措施: Paclitaxel (Drug)
Paclitaxel only
Standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Number of Participants With Pathologic Complete Response (pCR) (Rate of pCR)
时间窗: At time of surgery, an expected average of 24-26 weeks
Pathologic Complete Response was defined as the absence of invasive cancer in the breast and lymph nodes following completion of neoadjuvant systemic therapy and reported according to the current AJCC staging system for neoadjuvant clinical studies. The endpoint was to determine the pathologic Complete Response (pCR) rates associated with weekly treatment of MM-121 plus paclitaxel followed by the combination treatment of doxorubicin plus cyclophosphamide compared with weekly paclitaxel alone followed by the combination treatment of doxorubicin plus cyclophosphamide in patients with human epidermal growth factor receptor 2 (HER2)-negative primary breast cancer.
次要结局
未报告次要终点