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A Phase III Randomized Study of TH (Paclitaxel and Trastuzumab) Versus THL (Paclitaxel, Trastuzumab and Lapatinib) in First Line Treatment of HER2-positive Metastatic Breast Cancer (TH V THL)
The proposed phase III randomised trial will compare the efficacy of trastuzumab and paclitaxel with trastuzumab, paclitaxel and lapatinib in first line treatment of HER2 positive metastatic breast cancer. The investigators will also examine potential predictive biomarkers of response to trastuzumab and lapatinib in pre-treatment biopsy samples and serum samples.
Details
| Lead sponsor | Cancer Trials Ireland |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 75 |
| Start date | 2012-02-13 |
| Completion | 2023-02-17 |
Conditions
- Metastatic Breast Cancer
Interventions
- Trastuzumab
- Paclitaxel
- Lapatinib
Primary outcomes
- Progression Free Survival — 9 months
Countries
Finland, France, Germany, Ireland, Israel, Norway, Portugal, Spain