Efficacy and Safety Evaluating Study of CT-P6 in Her2 Positive Early Breast Cancer
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| ClinicalTrials.gov Identifier: NCT02162667 |
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Recruitment Status :
Completed
First Posted : June 13, 2014
Results First Posted : October 29, 2019
Last Update Posted : August 3, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HER2-positive Carcinoma of Breast | Drug: Trastuzumab | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 562 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | June 2014 |
| Actual Primary Completion Date : | May 26, 2016 |
| Actual Study Completion Date : | October 2018 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: CT-P6 |
Drug: Trastuzumab
Trastuzumab 6mg/kg is ongoing to be administered for both arms after 8mg/kg loading dose.
Other Name: Herceptin |
| Active Comparator: Trastuzumab |
Drug: Trastuzumab
Trastuzumab 6mg/kg is ongoing to be administered for both arms after 8mg/kg loading dose.
Other Name: Herceptin |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162667
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| Responsible Party: | Celltrion |
| ClinicalTrials.gov Identifier: | NCT02162667 |
| Other Study ID Numbers: |
CT-P6 3.2 2013-004525-84 ( EudraCT Number ) |
| First Posted: | June 13, 2014 Key Record Dates |
| Results First Posted: | October 29, 2019 |
| Last Update Posted: | August 3, 2022 |
| Last Verified: | October 2019 |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases |
Skin Diseases Trastuzumab Antineoplastic Agents, Immunological Antineoplastic Agents |