Phase 3
N=475
Demonstrate Efficacy and Safety of Metastatic Breast Cancer
Metastatic Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01084876 ↗Enrolled (actual)
475
Serious AEs
15.4%
Results posted
Feb 2025
Primary outcome: Primary: Objective Response Rate — 138; 143 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CT-P6 (Drug); Herceptin (Drug); Paclitaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Celltrion
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate |
138; 143 | — |
| SECONDARY Time to Progression |
11.07; 12.52; 10.99; 11.25 | — |
| SECONDARY Time to Response |
1.38; 1.38; 1.41; 1.41 | — |
| SECONDARY Progression Free Survival |
10.99; 11.15 | — |
| SECONDARY Overall Survival |
28.82; 26.84 | — |
| SECONDARY Safety Endpoints; Cardiotoxicity |
-4.56; -4.98 | — |
| SECONDARY Safety Endpoints; Immunogenicity |
4; 2; 1; 2; 3; 0 | — |
| SECONDARY Pharmacokinetic Endpoints; Ctroughss |
23.6; 24.2 | — |
Summary
The purpose of the study is to demonstrate equivalence
Eligibility Criteria
Inclusion Criteria
- Are females
- Have Her 2 over-expression
- Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Exclusion Criteria
- Current clinical or radiographic evidence central nervous system (CNS) metastases
- Current Known infection
- Pregnant or nursing mother
Data sourced from ClinicalTrials.gov (NCT01084876). 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.