Status:
COMPLETED
Randomized Phase II Trial of Letrozole With or Without Dasatinib as First and Second-line Treatment for Hormone Receptor-positive, HER2-negative Post-menopausal Breast Cancer That is Unresectable, Locally Recurrent or Metastatic
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
US Oncology Research
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to find out what effect the combination of letrozole (brand name: Femara) and dasatinib (brand name: Sprycel) has on metastatic breast cancer compared to letrozole alone
Eligibility Criteria
Inclusion
- For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
- Has histologic or cytologic diagnosis of breast cancer; evidence of unresectable locally recurrent or metastatic disease
- Has measurable or evaluable-only disease
- Is female, ≥18 yrs of age, post menopausal or surgically sterile
- HER2 negative, HR+, ER+ and/or PgR+ breast cancer
- 0-1 prior chemotherapy regimen for metastatic disease.
- Prior adjuvant or neoadjuvant chemotherapy completed at least 1 month prior
- Prior tamoxifen therapy is allowed
- No AI therapy for \>1 year without recurrence
Exclusion
- Pregnant or breast feeding
- Prior hormonal therapy for metastatic or locally recurrent disease
- \>1 chemotherapy regimen for metastatic disease
- Pleural or pericardial effusion
- Serious cardiac condition
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00696072
Start Date
August 1 2008
End Date
June 1 2014
Last Update
June 13 2016
Active Locations (27)
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1
Northern Arizona Hematology & Oncology Associates
Sedona, Arizona, United States, 86336
2
Arizona Oncology Associates D.B.A. Hematology Oncology
Tucson, Arizona, United States, 85704
3
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80220
4
Florida Cancer Institute - New Hope
Hudson, Florida, United States, 34667