Overview

Efficacy and Safety Evaluating Study of CT-P6 in Her2 Positive Early Breast Cancer

Status:
Completed
Trial end date:
2018-10-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Celltrion
Collaborators:
Nippon Kayaku Co., Ltd.
Nippon Kayaku Co.,Ltd.
Treatments:
Trastuzumab