Genetic Testing in Predicting Response to Paclitaxel in Women With Breast Cancer
RATIONALE: Analyzing genes for changes before and after chemotherapy may help doctors predict a patient's response to treatment and help plan the most effective treatment.
PURPOSE: This clinical trial is studying how well genetic testing works in predicting response to paclitaxel in women who have unresected breast cancer.
Genetic: microarray analysis
Procedure: neoadjuvant therapy
|Study Design:||Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Pilot Study to Establish a Standardized Protocol for Gene Microarray Analysis in Patients Receiving Neoadjuvant Chemotherapy for Breast Cancer: Identifying Factors Predictive of a Response to Paclitaxel|
- Overall response [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2001|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Paclitaxel given before surgery
subjects will receive paclitaxel neoadjuvantlyGenetic: microarray analysis
subjects will have a biopsy to collect tissue for gene microarray analysisProcedure: biopsy
All subjects will have a biopsy to collect tissueProcedure: neoadjuvant therapy
paclitaxel is given neoadjuvantlyDrug: Paclitaxel
All patients will receive paclitaxel neoadjuvantly
- Determine the feasibility of accruing women with unresected infiltrating carcinoma of the breast to a clinical trial involving serial breast biopsies and administration of neoadjuvant paclitaxel before formal assessment of axillary lymph node status.
- Determine a standard protocol template for gene microarray analysis, in terms of the timing and method of collecting tissue samples, before and after administration of neoadjuvant paclitaxel in these patients.
- Determine the safety and efficacy of tissue sampling in these patients.
- Identify gene(s) or gene clusters that exhibit significant differences between responding and non-responding tumors before treatment with neoadjuvant paclitaxel in these patients.
- Identify gene(s) or gene clusters that exhibit changes in gene expression before and after the administration of neoadjuvant paclitaxel in these patients.
- Compare significant differences in gene expression between responding and non-responding tumors in patients treated with this drug.
- Develop, preliminarily, a statistical model utilizing individual genes and/or gene clusters that can best predict response to paclitaxel in these patients.
OUTLINE: This is a pilot, multicenter study.
Patients undergo core needle breast biopsy within 14 days before starting neoadjuvant paclitaxel treatment. Patients receive neoadjuvant paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo core needle breast biopsy 48 hours after the first administration of paclitaxel, upon completion of course 1, and either upon completion of the last course (in patients with clinical or radiographic evidence of residual disease) or during definitive breast surgery. Biopsy samples are analyzed for gene expression by gene microarray analysis.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00088829
|United States, District of Columbia|
|Lombardi Comprehensive Cancer Center at Georgetown University Medical Center|
|Washington, District of Columbia, United States, 20007|
|Principal Investigator:||Minetta C. Liu, MD||Lombardi Cancer Research Center|