Pilot Study of Docetaxel & Bevacizumab +/- Trastuzumab in First-Line Treatment of Patients With Metastatic Breast Cancer
Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
Participant gender:
Summary
Pilot, phase II, parallel-group, open-label, noncomparative, prospective, multicenter study
designed to evaluate the progression-free survival of docetaxel and bevacizumab ± trastuzumab
for the first-line treatment of participants with metastatic breast cancer. Participants were
stratified according to human epidermal growth factor receptor-2 (HER2) status at the time of
enrollment. HER2 negative participants were assigned to receive docetaxel and bevacizumab
(DB). HER2 positive participants were assigned to receive docetaxel, bevacizumab, and
trastuzumab (DBT).
All participants (except one) were off study treatment on 30 June 2011. All efficacy analysis
and safety analysis was performed using the cut-off date of June 2011. One participant
continued treatment till 11 March 2012. For this participant, adverse events were collected
upto 19 April 2012 and included in the safety analysis.