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

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

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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

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