An Open-Label, Randomised Phase 1b/2 Study Of PF-04691502 In Combination With Letrozole Compared With Letrozole Alone In Patients With Estrogen Receptor Positive, Her-2 Negative Early Breast Cancer
The study was prematurely discontinued on 09Oct2012 due to the tolerability findings in 2
clinical studies testing PF-04691502 that have prompted the Sponsor to re-evaluate the
strategic goals of the program. In the study B1271003 an unexpected frequency of severe
skin toxicity was observed and in the study B1271004 5 cases of drug induced pneumonitis
were reported.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Change in biopsied tumor tissue from Baseline in Ki-67 (% positive tumor cells) at 6 weeks (Phase 2)
Baseline and Week 6
No
Pfizer CT.gov Call Center
Study Director
Pfizer
United Kingdon: Medicines and Healthcare Products Regulatory Agency
B1271003
NCT01430585
March 2012
December 2012
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