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

Study Overview
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Brief Summary
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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.

Official Title
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Phase 3 Efficacy and Safety Study of CT-P6 and Herceptin as Neoadjuvant and Adjuvant Treatment in Patients With Her2-positive Early Breast Cancer

Conditions
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HER2-positive Carcinoma of Breast

Intervention / Treatment
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* Drug: Trastuzumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT-P6<br> | Drug: Trastuzumab<br>* Trastuzumab 6mg/kg is ongoing to be administered for both arms after 8mg/kg loading dose.<br>* Other names: Herceptin;|
| Active Comparator: Trastuzumab<br> | Drug: Trastuzumab<br>* Trastuzumab 6mg/kg is ongoing to be administered for both arms after 8mg/kg loading dose.<br>* Other names: Herceptin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | After Neo-adjuvant therapy and Surgery (up to 30 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Patients Achieving Pathological Complete Response (pCR) of the Breast Regardless of DCIS With Positive or Unknown Nodal Status | 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. | After Neo-adjuvant therapy and Surgery (up to 30 weeks) | 
| The Percentage of Patients Achieving Pathological Complete Response of the Breast and Axillary Nodes With Absence of DCIS | 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. | After Neo-adjuvant therapy and Surgery (up to 30 weeks) | 
| Overall Response Rate (ORR) From Local Review | 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. | After Neo-adjuvant therapy (up to 24 weeks) | 
| Disease-free Survival | 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. | Up to 3 years from the day of last patient enrollment (during whole study period) | 
| Progression-Free Survival | 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. | Up to 3 years from the day of last patient enrollment (during whole study period) | 
| Overall Survival | Overall survival was defined as the interval between randomization and death from any cause. | Up to 3 years from the day of last patient enrollment (during whole study period) | 
| The Number of Patients Who Had Progressive Disease or Recurrence | 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. | Up to 3 years from the day of last patient enrollment (during whole study period) | 
| Maximum Serum Concentration After Administration (Cmax) in Each Cycle | 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. | End of each treatment cycles, up to 24 weeks (during neoadjuvant period) | 
| Trough Serum Concentration (Ctrough) in Each Cycle | 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. | Pre-infusion of cycles 1 to 8 during neoadjuvant period |