Clinical Trials List
Protocol NumberCT-P6 3.2
NCT Number(ClinicalTrials.gov Identfier)NCT02162667
2014-12-01 - 2018-11-30
Phase III
Terminated7
ICD-10C50.919
Malignant neoplasm of unspecified site of unspecified female breast
A Phase 3, Double-Blind, Randomized, Parallel-Group, Active-Controlled Study to Compare the Efficacy and Safety of CT-P6 and Herceptin as Neoadjuvant and Adjuvant Treatment in Patients with HER2-Positive Early Breast Cancer
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Trial Applicant
PPD DEVELOPMENT (HK) LIMITED
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Sponsor
CELLTRION, Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 林正耀 Division of Hematology & Oncology
- Shang-Wen Chen Division of Hematology & Oncology
- 黃文聰 Division of Hematology & Oncology
- Shang-Hung Chen Division of Hematology & Oncology
- 林明賢 Division of Hematology & Oncology
- 陳威宇 Division of Hematology & Oncology
- 曹朝榮 Division of Hematology & Oncology
- 林建良 Division of Hematology & Oncology
- 陳昭勳 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Liang-Chih Liu Division of General Surgery
- Chih-Jung Chen Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 甘蓉瑜 Division of General Surgery
- Fang-Ming Chen Division of General Surgery
- Fu Ouyang Division of General Surgery
- Chieh-Han Chuang Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- YEN-SHEN LU Division of Hematology & Oncology
- 郭文宏 Division of General Surgery
- 林璟宏 Division of Hematology & Oncology
- MING-YANG WANG Division of General Surgery
- 張端瑩 Division of Hematology & Oncology
- SUNG-HSIN KUO Division of Hematology & Oncology
- 陳怡君 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
HER2-Positive Early Breast Cancer
Objectives
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.
Test Drug
CT-P6
Active Ingredient
Trastuzumab
Dosage Form
Injection
Dosage
400
Endpoints
Primary Outcome Measures :
1. 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) [ Time Frame: 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 :
1. The Percentage of Patients Achieving Pathological Complete Response (pCR) of the Breast Regardless of DCIS With Positive or Unknown Nodal Status [ Time Frame: 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.
2. The Percentage of Patients Achieving Pathological Complete Response of the Breast and Axillary Nodes With Absence of DCIS [ Time Frame: 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.
3. Overall Response Rate (ORR) From Local Review [ Time Frame: 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.
4. Disease-free Survival [ Time Frame: 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.
5. Progression-Free Survival [ Time Frame: 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.
6. Overall Survival [ Time Frame: 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.
7. The Number of Patients Who Had Progressive Disease or Recurrence [ Time Frame: 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.
8. Maximum Serum Concentration After Administration (Cmax) in Each Cycle [ Time Frame: 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.
9. Trough Serum Concentration (Ctrough) in Each Cycle [ Time Frame: 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.
1. 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) [ Time Frame: 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 :
1. The Percentage of Patients Achieving Pathological Complete Response (pCR) of the Breast Regardless of DCIS With Positive or Unknown Nodal Status [ Time Frame: 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.
2. The Percentage of Patients Achieving Pathological Complete Response of the Breast and Axillary Nodes With Absence of DCIS [ Time Frame: 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.
3. Overall Response Rate (ORR) From Local Review [ Time Frame: 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.
4. Disease-free Survival [ Time Frame: 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.
5. Progression-Free Survival [ Time Frame: 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.
6. Overall Survival [ Time Frame: 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.
7. The Number of Patients Who Had Progressive Disease or Recurrence [ Time Frame: 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.
8. Maximum Serum Concentration After Administration (Cmax) in Each Cycle [ Time Frame: 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.
9. Trough Serum Concentration (Ctrough) in Each Cycle [ Time Frame: 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.
Inclution Criteria
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).
• 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
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.
• 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.
The Estimated Number of Participants
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Taiwan
20 participants
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Global
532 participants
