Phase 2
N=44
A Study of Dasatinib (BMS-354825) in Patients With Advanced 'Triple-negative' Breast Cancer
Breast Cancer · Metastasis
Bottom Line
View on ClinicalTrials.gov: NCT00371254 ↗Enrolled (actual)
44
Serious AEs
31.8%
Results posted
Mar 2011
Primary outcome: Primary: Number of Participants With Complete Response (CR) or Partial Response (PR) — 2; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dasatinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Complete Response (CR) or Partial Response (PR) |
2; 0 | — |
| PRIMARY Percentage of Participants With Complete Response (CR) or Partial Response (PR) |
8.7; 0.0 | — |
| SECONDARY Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study |
3; 1 | — |
| SECONDARY Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study |
13.04; 5.0 | — |
| SECONDARY Proportion of Participants With Progression-Free Survival (PFS) at Weeks 9, 17, and 25 |
0.40; 0.35; 0.32; 0.14; 0.21; 0.00 | — |
| SECONDARY Mean Number of Weeks of Complete Response (CR) or Partial Response (PR) |
31 | — |
| SECONDARY Mean Plasma Concentration at Week 3 |
9.02; 7.14; 2.88; 103.35; 66.41; 35.05 | — |
| SECONDARY Mean Plasma Concentration at Week 7 |
8.87; 4.89; 120.92; 84.36; 37.04; 44.80 | — |
| SECONDARY Mean Change in Concentration of Collagen Type IV From Baseline |
39.51; 26.92; 34.31; 35.18 | — |
| SECONDARY Mean Change in Concentration of Vascular Endothelial Growth Factor Receptor-2 (VEGFR2) From Baseline |
25.07; 18.59; 33.56; 25.12 | — |
| SECONDARY Percentage Change in Tumor Biomarkers |
— | — |
| SECONDARY Profiling of Messenger-ribonucleic Acid (mRNA) Expression: mRNA Signal Intensity |
— | — |
| SECONDARY Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs) or Adverse Events (AEs) |
1; 0; 11; 3; 23; 21 | — |
| SECONDARY Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3 AEs and Discontinuations Due to Drug-related AEs |
5; 1; 23; 19; 12; 8 | — |
| SECONDARY Most Frequent Drug-related Adverse Events (AEs) |
12; 7; 10; 14; 10; 14 | — |
| SECONDARY Number of Participants With Grade 3 or 4 Abnormalities in Hematology Measurements |
3; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Abnormalities (Grade 1 or 2) in Prothrombin Time (PT) |
3; 0; 0; 0 | — |
| SECONDARY Number of Participants With Abnormalities (Grade 1 or 2) in Partial Thromboplastin Time (PTT) |
0; 0 | — |
| SECONDARY Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase |
1; 1; 1; 3; 0; 3 | — |
| SECONDARY Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Calcium, Potassium, Magnesium and Sodium |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Creatinine, Bicarbonate, Inorganic Phosphorous and Bilirubin (Total). |
0; 0; 0; 0; 1; 2 | — |
| SECONDARY Number of Participants With Identified Electrocardiogram (ECG) Abnormalities |
4; 3 | — |
| SECONDARY Number of Participants With Abnormal Vital Signs Measurements |
0; 0 | — |
Summary
This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced triple-negative breast cancer.
Eligibility Criteria
Inclusion Criteria
- females, 18 or older
- recurrent or progressive locally advanced, or 'triple negative' metastatic breast cancer
- paraffin-embedded tissue block must be available
- measurable disease
- prior chemotherapy with an anthracycline, a taxane, or both (neoadjuvant, adjuvant, or metastatic setting)
- 0, 1 or 2 chemotherapies in the metastatic setting
- adequate organ function
Exclusion Criteria
- Metastatic disease confined to bone only
- Symptomatic CNS metastasis
- Concurrent medical condition which may increase the risk of toxicity
- Unable to take oral medication
Data sourced from ClinicalTrials.gov (NCT00371254). 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.