This trial provides a unique opportunity in that it combines genomic, proteomic and pharmacogenomic assessments in patients receiving chemotherapy for advanced breast cancer. To date no other trials have analyzed gene and protein expression at the same time points in the same patient, combined with clinical outcome. Similar to previous attempts to predict response based on expression of a single gene or protein, we expect that neither genomic or proteomic profiling alone will be sufficient to optimize therapy. Rather, we expect an iterative process that combines information gleaned from both platforms, modified to avoid toxicity based on pharmacogenomics.
Primary Outcome Measures:
- To correlate tumor gene expression (genomic profile) with response to paclitaxel + Avastin in patients with advanced breast cancer [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To correlate serum and tumor proteomic profiles with response; To compare serum and tissue proteomic analyses; To compare genomic and proteomic profiles; To correlate toxicity and/or response with drug-specific pharmacogenomic parameters. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Estimated Enrollment: |
40 |
Study Start Date: |
September 2007 |
Estimated Study Completion Date: |
September 2009 |
Estimated Primary Completion Date: |
June 2009 (Final data collection date for primary outcome measure) |
1: Active Comparator
Paclitaxel + Avastin
|
Procedure: Core Biopsy
biopsy
Procedure: Blood Collection
Blood/serum sample
Drug: Paclitaxel
Paclitaxel 90 mg/m2 IV, day 1, 8 and 15
Drug: Avastin
Avastin 10 mg/kg IV, day 1 and 15
|
OUTLINE: This is a multi-center study.
Sample Collection:
ECOG Performance Status of 0 or 1
Life Expectancy: Not specified
Hematopoietic:
- Platelet count > 100,000/mm³
- Absolute neutrophil count > 1200/mm³
- PTT < 1.5 x upper limit of normal
- INR < 1.5 x upper limit of normal
Hepatic:
- Total bilirubin < 1.5 mg/dL
- SGOT (AST) < 2 x upper limit of normal
Renal: Not specified
Cardiovascular:
- Clinically significant cardiovascular or cerebrovascular disease including prior myocardial infarction (within 6 months prior to study entry), unstable angina, Grade II or greater peripheral vascular disease, New York Heart Association (NYHA) Grade II or greater congestive heart failure, hypertensive crises, hypertensive encephalopathy or uncontrolled hypertension (SBP>150, DBP>100).