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)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Recurrent or progressive locally-advanced or metastatic 'triple-negative' breast cancer
Sponsor: Bristol-Myers Squibb International Corporation
Enrollment: 45
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

November 10, 2006

End Date

September 9, 2008

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•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):

•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