Recurrent or progressive locally-advanced or metastatic 'triple-negative' breast cancer
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Signed written informed consent according to institutional guidelines. Target population 2) Invasive breast cancer based on previous biopsy, documented as negative for expression of Estrogen and Progesterone Receptor [=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Sex and Reproductive Status 1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 12 weeks after the study. 2) Women who are pregnant or breastfeeding 3) Women with a positive pregnancy test on enrollment or prior to study drug administration Target Disease Exceptions 4) Metastatic disease confined to bone only 5) Symptomatic CNS metastasis (see section 7.2.1) Medical History and Concurrent Diseases 6) Any anti-neoplastic therapy, including radiotherapy, or intravenous bisphosphonate within 14 days prior to study drug start 7) Prior administration of any small-molecule ‘targeted’ kinase inhibitor or any investigational agent 8) Other malignancy requiring radiotherapy or systemic treatment within 3 years 9) Concurrent medical condition which may increase the risk of toxicity, including: a) Pleural or pericardial effusion of any grade b) Clinically-significant coagulation or platelet function disorder (e.g. known von Willebrand’s disease) c) Infection requiring intravenous antibiotics d) Requirement for prohibited concomitant therapy (see section 6.4.1) e) Ongoing or recent (=3 months) significant gastrointestinal bleeding f) Clinically-significant cardiovascular disease, including myocardial infarction or ventricular tachyarrhythmia within 6 months, prolonged QTc >450 msec. (Fridericia correction), EF <40% or major conduction abnormality (unless a cardiac pacemaker is present) g) Other medical condition which in the opinion of the Investigator might confer an unacceptable increase in risk Other Exclusion Criteria 10) Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness 11) Inability to take oral medication for any reason 12) Inability to understand the potential risks and provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate objective response rate (ORR) of dasatinib in women with recurrent or progressive locally-advanced or metastatic 'triple-negative' breast cancer.;Secondary Objective: 1. To estimate, by subgroup, Disease Control Rate (DCR) and proportion free of progression at week 9, 17 and 25, Progression-Free Survival (PFS) distribution, and response duration 2. To determine the safety and tolerability of dasatinib in this population 3. To obtain pharmacokinetic (PK) and pharmacodynamic data 4. To obtain exploratory tumor biomarker and pharmacogenomic data;Primary end point(s): Efficacy: Anti-tumor efficacy will be assessed by radiographic or clinical measurement. Primary analysis will be radiographically-defined Objective Response Rate (ORR) by RECIST criteria. Disease control rate (DCR) will be the key secondary efficacy endpoint and basis for interim analysis. Safety/tolerability: Safety and tolerability is a main secondary endpoint. Adverse events will be assessed continuously and graded according to NCI Common Terminology Criteria for Adverse Events version 3.0 (CTCAEv3) for all treated subjects. | — |
Countries
Belgium, France, Italy
Outcome results
None listed