Phase 3 N=562 Randomized Double-blind Treatment

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

HER2-positive Carcinoma of Breast

Bottom Line

View on ClinicalTrials.gov: NCT02162667 ↗

Enrolled (actual)

562

Serious AEs

10.6%

Results posted

Oct 2019

Primary outcome: 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 percentage of responders

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Trastuzumab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Celltrion
Primary completion: May 2016

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	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02162667). 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.