Phase II Study of Dasatinib (BMS-354825) for Advanced ‘Triple-negative’ Breast Cancer+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 2.0 dated 16-Aug-06)+ Pharmacogenomics Tissue Sample Amendment Number 02 - Site Specific - (version 1.0 dated 16-Aug-06)
- Conditions
- Recurrent or progressive locally-advanced or metastatic 'triple-negative' breast cancer
- Registration Number
- EUCTR2006-002045-36-FR
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 45
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 [<10% of cells stained] and for Her2/neu [IHC 0-1+ or CISH/FISH-negative]
3) A paraffin-embedded tissue block from prior surgery must be available
4) Measurable, recurrent or progressive, locally-advanced or metastatic disease assessed within 28 days prior to study drug start (see Protocol section 3.2). At least one target lesion (see Protocol section 3.3.2) must be identified.
5) Prior chemotherapy with an anthracycline, a taxane, or both (adjuvant or metastatic)
6) Zero or one chemotherapy regimen in the locally-advanced or metastatic setting
7) Recovered to Grade =1 from toxicities of prior therapy (except alopecia)
8) Performance status (ECOG) 0 – 1
9) Adequate organ function (CTCAE v.3.0 severity grading):
a) Hepatic enzymes (AST, ALT), Total bilirubin all Grade 0 – 1
b) Serum Ca2+ = Lower Limit of Normal (LLN)
c) Serum K+, Mg2+, Phosphate all Grade 0 – 1
d) Creatinine Grade 0 – 2
e) Hemoglobin, Neutrophil count, Platelets, PT, PTT all Grade 0 – 1
Age and Sex
10) Females, age = 18 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method