Trials / Completed
CompletedNCT01526369
A Randomized Study of TH Versus THL in First Line Treatment of HER2-positive Metastatic Breast Cancer
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Cancer Trials Ireland · Network
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Trastuzumab | |
| DRUG | Paclitaxel | |
| DRUG | Lapatinib |
Timeline
- Start date
- 2012-02-13
- Primary completion
- 2015-11-01
- Completion
- 2023-02-17
- First posted
- 2012-02-03
- Last updated
- 2025-05-09
Locations
35 sites across 8 countries: Finland, France, Germany, Ireland, Israel, Norway, Portugal, Spain
Source: ClinicalTrials.gov record NCT01526369. Inclusion in this directory is not an endorsement.