A5481008
Research type
Research Study
Full title
A RANDOMIZED, MULTICENTER, DOUBLE BLIND PHASE 3 STUDY OF PD 0332991 (ORAL CDK 4/6 INHIBITOR) PLUS LETROZOLE VERSUS PLACEBO PLUS LETROZOLE FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH ER (+), HER2 (-) BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI CANCER TREATMENT FOR ADVANCED DISEASE.
IRAS ID
127164
Contact name
Catherine Harper-Wynne
Contact email
Sponsor organisation
Pfizer Inc
Eudract number
2012-004601-27
Clinicaltrials.gov Identifier
Research summary
This randomized Phase 3 Study (A5481008) provides the opportunity to confirm the clinical benefit of the combination of PD 0332991 with letrozole observed in the randomized Phase 2 study. This study is designed to demonstrate that the combination of PD-0332991 with letrozole provides superior clinical benefit compared to letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) ABC who have not received any prior systemic anti cancer therapies for their advanced disease. The eligible patients are those who would be suitable for treatment with letrozole and not chemotherapy, i.e. those with limited advanced disease e.g. not involving vital organs.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
13/LO/0740
Date of REC Opinion
9 Aug 2013
REC opinion
Further Information Favourable Opinion