Phase 2
Completed N=120
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
Source: ClinicalTrials.gov NCT00696072 ↗Enrolled (actual)
120
Serious AEs
13.3%
Results posted
May 2016
Primary outcomePrimary: Number of Participants With Clinical Benefit (CBR) and Number of Participants With CBR Having a Disease Free Interval (DFI) Greater Than 2 Years - Evaluable Population — 40; 40; 20; 20 participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinical Benefit (CBR) and Number of Participants With CBR Having a Disease Free Interval (DFI) Greater Than 2 Years - Evaluable Population |
40; 40; 20; 20; 20; 20 | — |
| SECONDARY Number of Participants With Complete Response, Partial Response, Stable Disease, and Disease Progression |
1; 0; 12; 15; 32; 30 | — |
| SECONDARY Median Progression Free Survival (PFS) - Intent to Treat (ITT) Population |
20.1; 9.9 | — |
| SECONDARY Percentage of Participants Best Overall Response After Change From Letrozole to Letrozole Plus Dasatinib |
34.3; 22.9; 22.9; 20.0; 2.9; 2.9 | — |
| SECONDARY Percentage of Participants With PFS At 6 Months and At 12 Months - ITT Population |
77.2; 66.2; 64.6; 42.9 | — |
| SECONDARY Median Time to Treatment Failure (TTF) - ITT Population |
10.2; 9.2 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) Leading to Discontinuation, Serious Adverse Events (SAEs), and Deaths |
11; 16; 14; 2; 10; 6 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00696072). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.