Clinical Trials
B-44-I BETH Study:
A multicenter phase III randomized trial of adjuvant therapy for patients with HER2-positive node-positive or high risk node negative breast cancer comparing chemotherapy plus trastuzumab with chemotherapy plus trastuzumab plus bevacizumab.
The purpose of the study is to learn if adding bevacizumab to standard treatment with chemotherapy and trastuzumab for HER2-positive breast cancer will prevent breast cancer from returning. We also hope to learn if adding bevacizumab to treatment with chemotherapy and trastuzumab for HER2-positive breast cancer will prevent breast cancer from spreading to other parts of the body.
Subjects will receive docetaxel followed by carboplatin and Herceptin (combination chemotherapy) for 6 cycles (5 months) OR doxetaxel followed by carboplatin plus Herceptin and befacizumab for 6 cycles (5 months). After treatment subjects will be followed for 10 years.
Hormonal therapy is allowed as well as radiation therapy if patient had breast conserving surgery.
Tests covered by the study are: urine test to check for protein, echocardiogram or MUGA (months 15, 24,36 and 60 after start of the study and befacizumab will be provided at no cost.
Contact study coordinators Amy Jackson at 713-798-9143 or Toni Sinclair at 713-798-1911.