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TH vs THL in First-Line HER2-Positive Metastatic Breast Cancer
NCT01526369Phase 3
Key facts
- Status
- Completed
- Start
- Feb 2012
- Primary completion
- Nov 2015
- Countries
- 8
- Sponsor
- Cancer Trials Ireland
- Modality
- Small Molecules
- Drugs
- lapatinib
- Conditions
- HER2-positive metastatic breast cancer
01
Overview
Phase 3, randomised, open-label trial of lapatinib in HER2-positive metastatic breast cancer (2 arms), sponsored by Cancer Trials Ireland. Primary endpoint: Progression Free Survival at 9 months. Started Feb 2012; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Paclitaxel + Trastuzumab
Standard of care arm
Paclitaxel + Trastuzumab + Lapatinib
Experimental arm
03
Who it enrols
Adult females with HER2-positive metastatic breast cancer, ECOG 0-1, measurable disease, and adequate organ function. Excludes prior systemic therapy for metastatic disease (except hormonal), prior lapatinib, and CNS metastases.
04
Endpoints
Primary
Progression Free Survival
Secondary
Overall Survival
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