Status:
TERMINATED
Pre-Operative Study of PF-4691502 With Letrozole Compared To Letrozole Alone In Patients With Early Breast Cancer
Lead Sponsor:
Pfizer
Conditions:
Early Breast Cancer (Phase 2)
Advanced Breast Cancer (Phase 1b)
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
PF-04691502 is an inhibitor of PI3K and mTOR kinase. Published data support the hypothesis that a PI3K/mTOR antagonist in combination with letrozole might mitigate the intrinsic or acquired resistance...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Phase 1 - Postmenopausal women with diagnosis of breast cancer, metastatic disease or locally advanced disease / Estrogen Receptor positive and HER-2 negative / candidate to receive Letrozole
- Phase 2 - Postmenopausal women with newly diagnosed primary breast cancer / Estrogen Receptor positive and HER-2 negative / Ki-67 levels \>10% positive cells
- Phase 1 \& 2 - Glucose control, adequate bone marrow, liver, renal, and cardiac function
Exclusion
- Inflammatory carcinoma / Prior therapy with an agent active on PI3K and/or mTOR / Significant gastrointestinal abnormalities, which may impair intake, transit or absorption of the study drugs / Current or anticipated need for food or drugs that are known inhibitors or inducers of CYP3A4
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01430585
Start Date
March 1 2012
End Date
December 1 2012
Last Update
August 12 2014
Active Locations (5)
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1
Pfizer Investigational Site
Charleroi, Belgium, 6000
2
Pfizer Investigational Site
Milan, Italy, 20132
3
Pfizer Investigational Site
Barcelona, Barcelona, Spain, 08035
4
Pfizer Investigational Site
Gothenburg, Sweden, 413 45