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.
OBJECTIVE
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.


CONCLUSIONS
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.
Ruff
Paul
P
Division of Medical Oncology, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa. pruff@iafrica.com
Vorobiof
D A
DA
Jordaan
J P
JP
Demetriou
G S
GS
Moodley
S D
SD
Nosworthy
A L
AL
Werner
I D
ID
Raats
J
J
Burgess
L J
LJ
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003986:Dibenzocycloheptenes / Q000008:administration & dosage; D018572:Disease-Free Survival; D000077143:Docetaxel; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D010919:Placebos; D011804:Quinolines / Q000008:administration & dosage; D012008:Recurrence; D043823:Taxoids / Q000008:administration & dosage
D003986:Dibenzocycloheptenes; D010919:Placebos; D011804:Quinolines; D043823:Taxoids; D000077143:Docetaxel; C095179:zosuquidar trihydrochloride