Phase 2
Completed N=99
Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor
Source: ClinicalTrials.gov NCT00754325 ↗Enrolled (actual)
99
Serious AEs
26.7%
Results posted
May 2016
Primary outcomePrimary: Number of Participants With Disease Progression (PD) or Death — 35; 40 participants
Summary
The purpose of this study is to find out what effect the combination of fulvestrant (Faslodex) and dasatinib (Sprycel) has on advanced breast cancer compared to fulvestrant alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Disease Progression (PD) or Death |
35; 40 | — |
| SECONDARY Median Time of Progression-free Survival (PFS) |
5.6; 5.3 | — |
| SECONDARY Percentage of Participants With Progression Free Survival (PFS) at 6 Months |
48.1; 44.6 | — |
| SECONDARY Percentage of Participants With Clinical Benefit for At Least 6 Months |
38.0; 42.9 | — |
| SECONDARY Number of Participants With Complete Response (CR) , Partial Response (PR), Stable Disease (SD), and Disease Progression (PD) |
0; 0; 1; 3; 34; 28 | — |
| SECONDARY Number of Participants With Best Overall Response |
1; 2 | — |
| SECONDARY Number of Participants With Serious Adverse Events, Death, and Discontinuation Due to Adverse Events |
14; 11; 15; 16; 7; 6 | — |
Eligibility Criteria
For more information regarding Bristol-Myers Squibb (BMS) clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria
- Histologically confirmed hormone receptor positive (HR+) [(estrogen receptor (ER+) and/or progesterone receptors(PgR+)] breast cancer according to immunohistochemistry (IHC)
- Measureable or evaluable-only disease
- human epidermal growth factor receptor 2+ (HER2+) or HER2- breast cancer
- Males and females ≥18 years of age
- Females are post menopausal or surgically sterile
- Recurrent or progressive advanced breast cancer (locally-advanced or metastatic), that has progressed: (a) during or within 12 months after completion of adjuvant Aromatase Inhibitor (AI) treatment OR (b) during AI treatment in advanced setting (metastatic therapy)
Exclusion Criteria
- Pregnant or breast feeding
- >1 chemotherapy regimen for advanced disease
- Pleural or pericardial effusion
- Serious cardiac condition
Data sourced from ClinicalTrials.gov (NCT00754325). 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.