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
Status: | Completed |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/2/2013 |
Start Date: | October 2008 |
End Date: | February 2015 |
Contact: | For participation information at a USA site use a phone number below. For site information outside the USA please email: |
Email: | Clinical.Trials@bms.com |
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
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
33
sites
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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Cancer Care Centers of South Texas At Cancer Care Centers of South Texas, we are...
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