A Pilot, Phase II, Multicenter, Open-Label, Prospective Evaluation of Docetaxel and Bevacizumab ± Trastuzumab in the First-Line Treatment of Patients With Metastatic Breast Cancer
The study included:
- Study registration on Day 1: Treatment Cycle 1 was initiated within 14 days of signing
informed consent
- Treatment was administered in 3 week treatment cycles until the participant developed
unacceptable toxicity, had disease progression, withdrew consent, or died
- If participants experienced a complete response (CR), partial response (PR), or stable
disease (SD) at Cycle 8 or beyond or had unacceptable toxicity due to docetaxel, they
could continue on bevacizumab and/or trastuzumab until they developed unacceptable
toxicity, had disease progression, or withdrew consent
- Participants had follow-up assessments within 30 days after discontinuation of
treatment with the last of the study drugs for any reason other than death
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free Survival (PFS) Rate: Percentage of Participants With PFS
PFS was the time from registration to first documentation of progressive disease (PD) based on Response Evaluation Criteria in Solid Tumors (RECIST) - criteria pre-defining changes in lesion size or appearance symptomatic deterioration death due to any cause (in absence of PD). The Percentage of participants with PFS is reported. For the analysis, participants were censored on the last available tumor assessment date on study treatment if they had no PFS event were on anticancer therapy not related to study treatment on the registration date if they did not receive study drug had no post baseline tumor assessment
Up to 6 months and 12 months after treatment initiation
No
Barry Childs, MD
Study Director
Sanofi
United States: Food and Drug Administration
DOCET_L_00712
NCT00364611
August 2006
April 2012
Name | Location |
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Sanofi-Aventis Administrative Office | Bridgewater, New Jersey 08807 |