Status:
TERMINATED
Study Evaluating Bosutinib-Exemestane Combination Vs Exemestane Alone in Post Menopausal Women With Breast Cancer
Lead Sponsor:
Pfizer
Conditions:
Advanced Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This is a phase 2, open-label, multicenter, 2-arm study of bosutinib administered in combination with exemestane versus exemestane alone. This is a 2-part study consisting of a safety lead-in phase an...
Detailed Description
This study was terminated on 19 Apr 2010 due to unfavorable risk benefit ratio which did not support continuation in part 2 of the study. Even if the safety profile of the combination of Bosutinib and...
Eligibility Criteria
Inclusion
- Woman aged 18 years or older.
- Confirmed pathologic diagnosis of breast cancer.
- Locally advanced, metastatic, or locoregional recurrent breast cancer not amenable to curative treatment with surgery or radiotherapy.
- Surgically sterile or postmenopausal woman.
- Documented ER+ and/or PgR+ and erbB2- tumor.
- Progression of locally advanced or metastatic disease during treatment with a nonsteroidal AI or tamoxifen, or progression during treatment with (or within 6 months of discontinuation of) an adjuvant nonsteroidal AI.
Exclusion
- Prior exemestane, prior bosutinib, or any other prior anti-Src therapy.
- More than 1 prior endocrine treatment for locally advanced or MBC.
- More than 1 prior cytotoxic chemotherapy regimen in metastatic setting.
- Bone or skin as the only site of disease.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00793546
Start Date
February 1 2009
End Date
June 1 2010
Last Update
November 5 2012
Active Locations (28)
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1
Pfizer Investigational Site
Lake Worth, Florida, United States, 33461
2
Pfizer Investigational Site
Joliet, Illinois, United States, 60435
3
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
4
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115