This trial is active, not recruiting.

Condition her2-positive carcinoma of breast
Treatment trastuzumab
Phase phase 3
Target HER2
Sponsor Celltrion
Collaborator Nippon Kayaku Co.,Ltd.
Start date June 2014
End date December 2016
Trial size 562 participants
Trial identifier NCT02162667, 2013-004525-84, CT-P6 3.2


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-equivalence study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
trastuzumab Herceptin
Trastuzumab 6mg/kg is ongoing to be administered for both arms after 8mg/kg loading dose.
(Active Comparator)
trastuzumab Herceptin
Trastuzumab 6mg/kg is ongoing to be administered for both arms after 8mg/kg loading dose.

Primary Outcomes

Equivalence to Herceptin as determined by pCR (pathological Complete Response)
time frame: After Neo-adjuvant therapy and Surgery (up to 30 weeks)

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title Phase 3 Efficacy and Safety Study of CT-P6 and Herceptin as Neoadjuvant and Adjuvant Treatment in Patients With Her2-positive Early Breast Cancer
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Celltrion.