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

Celltrion Healthcare

Status and phase

Completed

Phase 3

Conditions

HER2-positive Carcinoma of Breast

Treatments

Drug: Trastuzumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02162667

2013-004525-84 (EudraCT Number)

CT-P6 3.2

Details and patient eligibility

About

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.

Enrollment

562 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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).

Exclusion criteria

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.