EUCTR2006-002178-23-FR
Active, not recruiting
Phase 1
Phase II Study of Dasatinib (BMS-354825) for Advanced Estrogen/Progesterone Receptor-Positive or Her2/neu-Positive Breast Cancer+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0 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
- Not specified
- Sponsor
- Bristol-Myers Squibb International Corporation
- Enrollment
- 80
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Signed written informed consent according to institutional guidelines
- •Target population
- •2\) Invasive breast cancer based on previous biopsy with documented amplification of Her2/neu (regardless of ER/PgR status; Group A) or expression of Estrogen and/or Progesterone Receptor (Group B); see Protocol section 3\.2\.1 for details.
- •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 including an anthracycline and a taxane, and with trastuzumab (Group A) and/or hormonal therapy (either Group)
- •6\) One or two chemotherapy regimens in the 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):
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 Protocol 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 (21 days for trastuzumab)
- •7\) Other malignancy requiring radiotherapy or systemic treatment within 3 years
Outcomes
Primary Outcomes
Not specified
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