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
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: US Oncology Research
• Treatments: Dasatinib; Hormones; Letrozole

Criteria

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