Clinical Trials
H-18251 – A Randomized, Double Blind, Placebo-Controlled, Multicenter, Phase III Study Comparing the Activity of Paclitaxel Plus Trastuzumab Plus Lapatinib to Paclitaxel Plus Trastuzumab Plus Placebo in Women with ERBB2 (HER2) Overexpressing Metastatic Breast Cancer
We look forward to your approval.
This is a multi-center study for patients with HER2 amplified metastatic breast cancer. There are two phases to this trial; the first twenty patients on this study will receive lapatinib in combination with both paclitaxel and trastuzumab. This will determine the safety and tolerability of and determine the clinical activity of lapatinib when administered in combination with paclitaxel and trastuzumab. In the second phase, up to 700 patients will be randomly assigned to receiving paclitaxel plus trastuzumab plus lapatinib OR paclitaxel plus trastuzumab plus placebo. The study will compare time to progression (TTP) in the 2 treatment arms as well as: overall survival, progression-free survival, overall response rate, clinical benefit (CR, PR, and stable disease for 24 weeks), time to response, and duration of response.
- Patient Population:
- Stage IV (Metastatic) HER2+ breast cancer.
- Patients must have tumor tissue available for central testing.
- Prior chemotherapy (and trastuzumab) in the adjuvant setting is allowed.
- Chemotherapy is the metastatic setting is not allowed
- Prior Hormonal therapy in any setting is allowed.
Patients will receive:
Only research related procedures will be covered by the study. The subjects will not be paid for participation and will be responsible for the cost of standard care for metastatic breast cancer.
If interested, contact the study coordinator at 713- 798-1986.