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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
562
Trastuzumab 6mg/kg is ongoing to be administered for both arms after 8mg/kg loading dose.
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.
Time frame: After Neo-adjuvant therapy and Surgery (up to 30 weeks)
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.
Time frame: 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.
Time frame: 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.
Time frame: After Neo-adjuvant therapy (up to 24 weeks)
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Buenos Aires, Argentina
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Córdoba, Argentina
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Quilmes, Argentina
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Rosario, Argentina
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San Salvador de Jujuy, Argentina
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Santa Rosa, Argentina
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Brest, Belarus
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Minsk, Belarus
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Minsk, Belarus
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Sarajevo, Bosnia and Herzegovina
...and 88 more locations
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pre-infusion of cycles 1 to 8 during neoadjuvant period