Phase II Study of Dasatinib (BMS-354825) for Advanced 'Triple-negative' Breast Cancer

Bristol-Myers Squibb6 sites in 2 countries55 target enrollmentDecember 2006

ConditionsBreast Cancer Metastasis

InterventionsDasatinib

DrugsDasatinib

Overview

Phase: Phase 2
Intervention: Dasatinib
Conditions: Breast Cancer
Sponsor: Bristol-Myers Squibb
Enrollment: 55
Locations: 6
Primary Endpoint: Number of Participants With Complete Response (CR) or Partial Response (PR)
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced triple-negative breast cancer.

Registry

clinicaltrials.gov

Start Date

December 2006

End Date

September 2008

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Bristol-Myers Squibb

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

Arms & Interventions

1

Intervention: Dasatinib

2

Intervention: Dasatinib

Outcomes

Primary Outcomes

Number of Participants With Complete Response (CR) or Partial Response (PR)

Time Frame: Baseline to end of study drug therapy (up to 65 weeks).

Tumor response was defined as the number of participants whose best response was CR or PR, per the Response Evaluation Criteria in Solid Tumor (RECIST): CR: disappearance of all target/non-target lesions; PR: \>= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD.

Percentage of Participants With Complete Response (CR) or Partial Response (PR)

Time Frame: Baseline to end of study drug therapy (up to 65 weeks).

The percentage of participants whose best response was CR or PR, per the RECIST: CR: disappearance of all target/non-target lesions; PR: \>= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD.

Secondary Outcomes

Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study(Baseline to 16 weeks.)
Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study(Baseline to 16 weeks)
Proportion of Participants With Progression-Free Survival (PFS) at Weeks 9, 17, and 25(Weeks 9, 17, and 25)
Mean Number of Weeks of Complete Response (CR) or Partial Response (PR)(Baseline to end of study drug therapy (up to 53.86 weeks))
Mean Plasma Concentration at Week 3(At pre-dose and 1, 3, 6 and 12 hours after each dose administration)
Mean Plasma Concentration at Week 7(At pre-dose and 1, 3, 6 and 12 hours after each dose administration)
Mean Change in Concentration of Collagen Type IV From Baseline(Baseline, Week 3 and Week 5)
Mean Change in Concentration of Vascular Endothelial Growth Factor Receptor-2 (VEGFR2) From Baseline(Baseline, Week 3 and Week 5)
Percentage Change in Tumor Biomarkers(Baseline)
Profiling of Messenger-ribonucleic Acid (mRNA) Expression: mRNA Signal Intensity(Baseline)
Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs) or Adverse Events (AEs)(From start of study drug therapy up to 30 days after the last dose.)
Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3 AEs and Discontinuations Due to Drug-related AEs(From start of study drug therapy up to 30 days after the last dose.)
Most Frequent Drug-related Adverse Events (AEs)(From start of study drug therapy up to 30 days after the last dose.)
Number of Participants With Grade 3 or 4 Abnormalities in Hematology Measurements(Throughout study, from start of study drug therapy up to 30 days after the last dose.)
Number of Participants With Abnormalities (Grade 1 or 2) in Prothrombin Time (PT)(Throughout study, from start of study drug therapy up to 30 days after the last dose.)
Number of Participants With Abnormalities (Grade 1 or 2) in Partial Thromboplastin Time (PTT)(Throughout study, from start of study drug therapy up to 30 days after the last dose.)
Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase(Throughout study, from start of study drug therapy up to 30 days after the last dose.)
Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Calcium, Potassium, Magnesium and Sodium(Throughout study, from start of study drug therapy up to 30 days after the last dose.)
Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Creatinine, Bicarbonate, Inorganic Phosphorous and Bilirubin (Total).(Throughout study, from start of study drug therapy up to 30 days after the last dose.)
Number of Participants With Identified Electrocardiogram (ECG) Abnormalities(Baseline, Weeks 3, 9, 17 and 25, then every 8 weeks until the end of study treatment (up to 17 weeks).)
Number of Participants With Abnormal Vital Signs Measurements(At each study visit (Week 3, 5, 7, 9, 13, 17 and 25) and end of treatment (up to 17 weeks))