Abstract
13047 Background: Taxol+Bevacizumab (B) has clinical activity in Her/2 negative chemotherapy naive MBC with a PFS (11.4 mo), RR (29.9%), and OS (28.4 mo). We are conducting a single arm Phase 2 trial to assess the efficacy of Docetaxel (D)+B. Primary endpoint: time to progression. Secondary endpoints: response rate (CR + PR), response duration, overall survival and safety. Methods: Eligibility criteria: MBC with no prior therapy; Her/2 negative by FISH, ECOG PS 0 or 1; measurable disease by RECIST, Hgb ≥ 9 g/dL, ANC ≥ 1.5 × 109/L, Platelet count ≥ 100 × 109/L, Creatinine ≤ 2.0 mg/dL, Total bilirubin ≤ 1.0 × upper limit of normal, no CNS metastasis, no MI or stroke within 6 mo, no GI perforation, no major surgery within 28 d, and no bleeding diathesis or coagulopathy. Pts receive B 15 mg/kg IV and D 75 mg/m2 IV Q 3 wk. Response assessed radiographically Q 3 cycles. Treatment is until disease progression or unacceptable toxicity. Results: Since Apr 2005, 43 of the planned 75 pts have been enrolled. 21 pts have had at least one assessment resulting in approximately 40% response rate. Common Gr3/4 AE’s have been neutropenia, febrile neutropenia, hypertension. Gr3 LVEF decline seen in one pt. No treatment related deaths occurred. Conclusions: D+ B is well tolerated, with no new safety concerns and manageable toxicities. D+B appears active in MBC. Updated efficacy and safety data will be presented. Study supported by Genentech, Inc. San Francisco, CA. No significant financial relationships to disclose.
Published Version
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