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 and phase
Completed
Phase 2
Conditions
Metastatic Breast Cancer
Treatments
Drug: Letrozole
Drug: Dasatinib
Details and patient eligibility
About
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
Enrollment
120 patients
Sex
Female
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion 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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
120 participants in 2 patient groups
A1
Active Comparator group
Treatment:
Drug: Dasatinib
Drug: Letrozole
A2
Active Comparator group
Treatment:
Drug: Letrozole
Trial contacts and locations
27
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Data sourced from clinicaltrials.gov
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