Phase 1
Completed N=31
Phase I Study of Dasatinib (BMS-354825) and Capecitabine for Women With Advanced Breast Cancer
Source: ClinicalTrials.gov NCT00452673 ↗Enrolled (actual)
31
Serious AEs
40.4%
Results posted
Dec 2013
Primary outcomePrimary: Number of Participants With Dose Limiting Toxicities Per Dose Level - Safety Population — 1; 1; 1; 2 participants
Summary
The purpose of this study is to learn about the safety and efficacy of Dasatinib in combination with Capecitabine for patients with advanced breast cancer, and who have received treatment with a taxane and an anthracycline
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicities Per Dose Level - Safety Population |
1; 1; 1; 2 | — |
| SECONDARY Number of Participants With Deaths, Serious Adverse Events, Adverse Events, Adverse Events Leading to Discontinuation and Treatment-related Adverse Events - Safety Population |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Overall Response to Tumor - Efficacy Evaluable Population |
0; 0; 0; 0; 1; 1 | — |
| SECONDARY Objective Response Rate (ORR) and Disease Control Rate - Efficacy Evaluable Population |
50.0; 16.67; 0; 24.0; 75.0; 33.33 | — |
| SECONDARY Number of Participants On-Study With Grade 3 - 4 Hematology Laboratory Test Values in Those Participants With a Baseline Laboratory Value of Grade 0 - Safety Population |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants On-study With Grade 3 - 4 Chemistry Laboratory Values in Those Participants With a Baseline Laboratory Value of Grade 0 - Safety Population |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email [email protected]. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.
Inclusion Criteria
- Female with advanced breast cancer previously treated with a taxane and an anthracycline
- No pleural or pericardial effusion
- Not receiving anticoagulants
Data sourced from ClinicalTrials.gov (NCT00452673). 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.