Efficacy and Safety Evaluating Study of CT-P6 in Her2 Positive Early Breast Cancer
- Registration Number
- NCT02162667
- Lead Sponsor
- Celltrion
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 562
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Trastuzumab Trastuzumab - CT-P6 Trastuzumab -
- Primary Outcome Measures
Name Time Method The Percentage of Patients Achieving Pathological Complete Response Defined as the Absence of Invasion Tumor Cells in the Breast and in Axillary Lymph Nodes, Regardless of Ductal Carcinoma in Situ (DCIS) After Neo-adjuvant therapy and Surgery (up to 30 weeks) Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period.
The primary endpoint, Pathological complete response, will be assessed using resected bio-specimens collected in breast and axilla during a surgery.
- Secondary Outcome Measures
Name Time Method The Percentage of Patients Achieving Pathological Complete Response (pCR) of the Breast Regardless of DCIS With Positive or Unknown Nodal Status After Neo-adjuvant therapy and Surgery (up to 30 weeks) Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period.
The secondary endpoint, other than pCR of breast and axillary nodes ragardless of DCIS which was primary endpoint, will be assessed using resected bio-specimens collected in breast and axilla during a surgery.Maximum Serum Concentration After Administration (Cmax) in Each Cycle End of each treatment cycles, up to 24 weeks (during neoadjuvant period) Pharmacokinetic samples were collected before study drug (CT-P6 or US-licensed Herceptin) administration (within 15 minutes prior to the beginning of the study drug infusion) and within 15 minutes after the end of the study drug infusion for each cycle during the Neoadjuvant Period. After the completion of treatment, an additional PK sample was collected at the EOT1.
Disease-free Survival Up to 3 years from the day of last patient enrollment (during whole study period) Patients who underwent breast surgery were included in the DFS analysis. Disease-free survival was defined as the interval between the date of breast surgery and disease progression, recurrence, or death from any cause, whichever occurred first. Only a recurrence or progression of disease that occurred before beginning another anticancer therapy was regarded as an event.
Overall Survival Up to 3 years from the day of last patient enrollment (during whole study period) Overall survival was defined as the interval between randomization and death from any cause.
The Number of Patients Who Had Progressive Disease or Recurrence Up to 3 years from the day of last patient enrollment (during whole study period) If recurrence or progression of disease occurred at any time during the study, the progressed tumor site was recorded in the "recurrence or progression of disease" eCRF page as local, regional, or distant, with diagnostic method and whether positive cytology or histology or not.
The resulting recurrence or progression of disease information was summarized as secondary endpoint.The Percentage of Patients Achieving Pathological Complete Response of the Breast and Axillary Nodes With Absence of DCIS After Neo-adjuvant therapy and Surgery (up to 30 weeks) Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period.
The secondary endpoint, other than pCR of breast and axillary nodes ragardless of DCIS which was primary endpoint, will be assessed using resected bio-specimens collected in breast and axilla during a surgery.Overall Response Rate (ORR) From Local Review After Neo-adjuvant therapy (up to 24 weeks) The ORR was defined as the proportion of patients with a BOR of CR or PR as assessed by RECIST guideline Version 1.1 during the Nedadjuvant Period.
Progression-Free Survival Up to 3 years from the day of last patient enrollment (during whole study period) Progression-free survival was defined as the interval between randomization and disease progression, recurrence, or death from any cause, whichever occurred first. Only a recurrence or progression of disease that occurred before beginning another anticancer therapy was regarded as an event.
Trough Serum Concentration (Ctrough) in Each Cycle Pre-infusion of cycles 1 to 8 during neoadjuvant period Pharmacokinetic samples were collected before study drug (CT-P6 or US-licensed Herceptin) administration (within 15 minutes prior to the beginning of the study drug infusion) and within 15 minutes after the end of the study drug infusion for each cycle during the Neoadjuvant Period. After the completion of treatment, an additional PK sample was collected at the EOT1.