A Phase 3, Double Blind, Randomized, Parallel Group, Active Controlled Study to Compare the Efficacy and Safety 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
- 进行中（未招募）
- 入组人数
- 532
- 试验地点
- 12
- 主要终点
- Equivalence to Herceptin as determined by pCR (pathological Complete Response). Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period.
研究概览
简要总结
This is a double-blind, randomized, parallel-group, active-controlled, multicenter, international, prospective Phase 3 study.This is the trial to see the equivalence of CT-P6 and Herceptin determined by pCR (pathological Complete Response) after surgery followed by 8 cycles of Neo-adjuvant therapy. Maximum 10 cycles of adjuvant therapy will be given to patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Patient is a female 18 years of age or older.
- •2.Patient who has Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or
- •3.Patient who has histologically confirmed and newly diagnosed breast cancer.
- •4.Patient who has clinical stage I, II, or IIIa operable breast cancer according to the AJCC Breast Cancer Staging 7th edition.
- •5.Patient who has HER2 positive status confirmed locally, defined as 3 + score by immunohistochemistry (IHC).
排除标准
- •1.Patient who has bilateral breast cancer.
- •2.Patient who is pregnant or lactating.
- •3.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.
结局指标
主要结局
Equivalence to Herceptin as determined by pCR (pathological Complete Response). Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period.
时间窗: After Neo-adjuvant therapy and Surgery (up to 30 weeks)
The primary endpoint, Pathological complete response, will be assessed using resected biospecimens collected in breast and axilla during a surgery.
时间窗: After Neo-adjuvant therapy and Surgery (up to 30 weeks)
次要结局
- The secondary objectives of this study are to evaluate additional efficacy parameters (such as ORR) and to obtain additional PK, Pharmacodynamics, safety, and biomarker data.(For a best overall response of SD, measurements must have met the SD criteria at least once after start of study treatment for a minimum interval of 6 weeks (42 days or more after first administration of study drug).)