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A randomized, placebo-controlled, double-blind phase 2 study of docetaxel compared to docetaxel plus zosuquidar (LY335979) in women with metastatic or locally recurrent breast cancer who have received one prior chemotherapy regimen.

Author(s): Ruff P, Vorobiof DA, Jordaan JP, Demetriou GS, Moodley SD, Nosworthy AL, Werner ID, Raats J, Burgess LJ

Affiliation(s): Division of Medical Oncology, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa. pruff@iafrica.com

Publication date & source: 2009-09, Cancer Chemother Pharmacol., 64(4):763-8. Epub 2009 Feb 25.

Publication type: Clinical Trial, Phase II; Multicenter Study; Randomized Controlled Trial

PURPOSE: To determine if concomitant administration of docetaxel plus zosuquidar.3HC1 can prolong progression-free survival in patients with metastatic breast cancer. METHODS: A randomized, double-blind, multicenter, placebo-controlled clinical trial comparing docetaxel plus 500 mg zosuquidar.3HCl (DZ) with docetaxel plus placebo (DP). RESULTS: A total of 170 patients were enrolled and randomly assigned to treatment. The median age was 53 years (range, 31-74 years). 81.7% of patients had prior chemotherapy in the adjuvant setting and 18.3% in the neoadjuvant setting. The median progression-free survival time was statistically different between groups [7.2 months (DZ) vs. 8.3 months (DP)]. Once the stratification factor relative to progression following prior chemotherapy was considered, no significant treatment difference existed. CONCLUSION: The combination of zosuquidar.3HCl plus docetaxel is safe. The analysis of efficacy data is complex, but it can be concluded that there is no difference in progression-free survival, overall survival, or response rate in the study as a whole.

Page last updated: 2009-10-20

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