Conditions: HER2-positive Carcinoma of Breast
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 562
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Trastuzumab
Intervention descriptions: intervention 1: Trastuzumab 6mg/kg is ongoing to be administered for both arms after 8mg/kg loading dose.

Protocol document: