drugset / Trial / NCT01526369
A Randomized Study of TH Versus THL in First Line Treatment of HER2-positive Metastatic Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2012-02-13
- Primary completion
- 2015-11
- Completion
- 2023-02-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lapatinib | Small molecule | 1000 mg | — |
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | — |
| Subject | Trastuzumab | Monoclonal antibody | 4 mg/kg | — |