Status:
COMPLETED
Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Advanced Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to find out what effect the combination of fulvestrant (Faslodex) and dasatinib (Sprycel) has on advanced breast cancer compared to fulvestrant alone.
Eligibility Criteria
Inclusion
- For more information regarding Bristol-Myers Squibb (BMS) clinical trial participation, please visit www.BMSStudyConnect.com.
- Histologically confirmed hormone receptor positive (HR+) \[(estrogen receptor (ER+) and/or progesterone receptors(PgR+)\] breast cancer according to immunohistochemistry (IHC)
- Measureable or evaluable-only disease
- human epidermal growth factor receptor 2+ (HER2+) or HER2- breast cancer
- Males and females ≥18 years of age
- Females are post menopausal or surgically sterile
- Recurrent or progressive advanced breast cancer (locally-advanced or metastatic), that has progressed: (a) during or within 12 months after completion of adjuvant Aromatase Inhibitor (AI) treatment OR (b) during AI treatment in advanced setting (metastatic therapy)
Exclusion
- Pregnant or breast feeding
- \>1 chemotherapy regimen for advanced disease
- Pleural or pericardial effusion
- Serious cardiac condition
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00754325
Start Date
September 1 2008
End Date
January 1 2014
Last Update
May 26 2016
Active Locations (28)
Enter a location and click search to find clinical trials sorted by distance.
1
Northern Arizona Hematology & Oncology Associates
Sedona, Arizona, United States, 86336-4937
2
Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope
Tucson, Arizona, United States, 85704
3
Florida Cancer Institute - New Hope
Hudson, Florida, United States, 34667-6594
4
Cancer Centers Of Florida, P.A
Ocoee, Florida, United States, 34761