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Pertuzumab retreatment in HER2-positive metastatic breast cancer
NCT02514681Phase 3
Key facts
- Status
- Completed
- Start
- Aug 2015
- Primary completion
- Dec 2018
- Countries
- 1
- Modality
- Monoclonal Antibodies
- Drugs
- pertuzumab
- Conditions
- HER2-positive metastatic breast cancer
01
Overview
Phase 3, randomised, open-label trial of pertuzumab in HER2-positive metastatic breast cancer (2 arms), sponsored by Japan Breast Cancer Research Group. Primary endpoint: Progression-Free Survival (Investigator Assessed) at 4 years. Started Aug 2015; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Trastuzumab + chemotherapy
Trastuzumab + Physician's Choice Chemotherapy
Trastuzumab + pertuzumab + chemotherapy
Trastuzumab + Pertuzumab + Physician's Choice Chemotherapy
03
Who it enrols
Patients with HER2-positive locally advanced or metastatic breast cancer who have previously received pertuzumab, trastuzumab, and chemotherapy (2 or 3 prior regimens).
04
Endpoints
Primary
Progression-Free Survival (Investigator Assessed)
Secondary
Progression-Free Survival (Independent Review)
Progression-Free Survival in patients treated with T-DM1 as latest regimen
Objective Response Rate
Duration of Response
Overall Survival
Patient-Reported Outcomes
Incidence and Grade of Adverse Events
Biomarker Analysis
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