Phase 3
Completed N=475
Demonstrate Efficacy and Safety of Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT01084876 ↗Enrolled (actual)
475
Serious AEs
15.4%
Results posted
Feb 2025
Primary outcomePrimary: Objective Response Rate — 138; 143 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of the study is to demonstrate equivalence
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 | — |
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. Informational only — not medical advice.