Phase 3
Completed N=562
Efficacy and Safety Evaluating Study of CT-P6 in Her2 Positive Early Breast Cancer
HER2-positive Carcinoma of Breast
Source: ClinicalTrials.gov NCT02162667 ↗
Enrolled (actual)
562
Serious AEs
10.6%
Results posted
Oct 2019
Primary outcomePrimary: 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) — 46.77; 50.39 percentage of responders
◆ Published Evidence
Highly cited
123citations · ~14 / year
CT-P6 compared with reference trastuzumab for HER2-positive breast cancer: a randomised, double-blind, active-controlled, phase 3 equivalence trial.
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.
Linked Publications (3)
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CT-P6 compared with reference trastuzumab for HER2-positive breast cancer: a randomised, double-blind, active-controlled, phase 3 equivalence trial.
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Efficacy and safety of CT-P6 versus reference trastuzumab in HER2-positive early breast cancer: updated results of a randomised phase 3 trial.
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Long-term efficacy and safety of CT-P6 versus trastuzumab in patients with HER2-positive early breast cancer: final results from a randomized phase III trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
46.77; 50.39 | — |
| SECONDARY The Percentage of Patients Achieving Pathological Complete Response (pCR) of the Breast Regardless of DCIS With Positive or Unknown Nodal Status |
4.84; 4.69 | — |
| SECONDARY The Percentage of Patients Achieving Pathological Complete Response of the Breast and Axillary Nodes With Absence of DCIS |
39.92; 41.41 | — |
| SECONDARY Overall Response Rate (ORR) From Local Review |
84.27; 83.98 | — |
| SECONDARY Disease-free Survival |
0.95; 0.96; 0.87; 0.89; 0.82; 0.82 | — |
| SECONDARY Progression-Free Survival |
0.99; 0.98; 0.90; 0.93; 0.82; 0.87 | — |
| SECONDARY Overall Survival |
1.00; 1.00; 0.98; 0.98; 0.95; 0.94 | — |
| SECONDARY The Number of Patients Who Had Progressive Disease or Recurrence |
41; 35; 1; 2; 5; 3 | — |
| SECONDARY Maximum Serum Concentration After Administration (Cmax) in Each Cycle |
186.428; 178.567; 145.078; 138.989; 145.183; 141.130 | — |
| SECONDARY Trough Serum Concentration (Ctrough) in Each Cycle |
18.915; 18.905; 17.346; 16.773; 16.796; 17.816 | — |
Eligibility 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).
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.
Data sourced from ClinicalTrials.gov (NCT02162667) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.