Phase 3 Efficacy and Safety Study of CT-P6 and Herceptin as Neoadjuvant and Adjuvant Treatment in Patients With Her2-positive Early Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Celltrion
- 入组人数
- 562
- 主要终点
- The Percentage of Patients Achieving Pathological Complete Response Defined as the Absence of Invasion Tumor Cells in the Breast and in Axillary Lymph Nodes, Regardless of Ductal Carcinoma in Situ (DCIS)
研究概览
简要总结
This study will determine whether CT-P6 and Herceptin are equivalent in patients with early-stage breast cancer undergoing neoadjuvant chemotherapy. Our hypothesis is that the pathologic complete response rate will be equivalent in patients treated with neoadjuvant CT-P6 or Herceptin. Patients will receive 8 cycles of neoadjuvant systemic therapy and up to 10 cycles of therapy in the adjuvant setting.
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
- Double (Participant, Investigator)
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
- •Patient who has histologically confirmed and newly diagnosed breast cancer
- •Patient who has clinical stage I, II, or IIIa operable breast cancer according to AJCC (American Joint Committee on Cancer) Breast Cancer Staging 7th edition
- •Patient who has HER2-positive status confirmed locally, defined as 3+ score by IHC (immuno-histochemistry).
排除标准
- •Patient who has bilateral breast cancer
- •Patient who has received prior treatment for breast cancer, including chemotherapy, biologic therapy, hormone therapy, immunotherapy, radiation or surgery, including any prior therapy with anthracyclines.
研究组 & 干预措施
CT-P6
干预措施: Trastuzumab (Drug)
Trastuzumab
干预措施: Trastuzumab (Drug)
结局指标
主要结局
The Percentage of Patients Achieving Pathological Complete Response Defined as the Absence of Invasion Tumor Cells in the Breast and in Axillary Lymph Nodes, Regardless of Ductal Carcinoma in Situ (DCIS)
时间窗: After Neo-adjuvant therapy and Surgery (up to 30 weeks)
Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period. The primary endpoint, Pathological complete response, will be assessed using resected bio-specimens collected in breast and axilla during a surgery.
次要结局
- The Percentage of Patients Achieving Pathological Complete Response (pCR) of the Breast Regardless of DCIS With Positive or Unknown Nodal Status(After Neo-adjuvant therapy and Surgery (up to 30 weeks))
- Maximum Serum Concentration After Administration (Cmax) in Each Cycle(End of each treatment cycles, up to 24 weeks (during neoadjuvant period))
- Disease-free Survival(Up to 3 years from the day of last patient enrollment (during whole study period))
- Overall Survival(Up to 3 years from the day of last patient enrollment (during whole study period))
- The Number of Patients Who Had Progressive Disease or Recurrence(Up to 3 years from the day of last patient enrollment (during whole study period))
- The Percentage of Patients Achieving Pathological Complete Response of the Breast and Axillary Nodes With Absence of DCIS(After Neo-adjuvant therapy and Surgery (up to 30 weeks))
- Overall Response Rate (ORR) From Local Review(After Neo-adjuvant therapy (up to 24 weeks))
- Progression-Free Survival(Up to 3 years from the day of last patient enrollment (during whole study period))
- Trough Serum Concentration (Ctrough) in Each Cycle(Pre-infusion of cycles 1 to 8 during neoadjuvant period)