Genetic Testing in Predicting Response to Paclitaxel in Women With Breast Cancer
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20007
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion:
Histologically confirmed infiltrating carcinoma of the breast
- Unresected disease
High-risk (> 50% risk of relapse) disease, including any of the following high-risk markers:
- Estrogen receptor- and progesterone receptor- negative
- Palpable axillary lymph nodes
- Grade 3 histology
- S phase fraction > 10%
- Ki67 > 30%
- Disease that warrants combination therapy with doxorubicin, cyclophosphamide, and paclitaxel
- HER2/neu negative or positive
Hormone receptor status:
- Not specified
Menopausal status
- Known
Performance status
- ECOG 0-2
- Absolute neutrophil count > 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin ≤ 1. 5 times normal (except for patients with known Gilbert's disease)
- Creatinine ≤ 1.5 times normal
Exclusion:
- uncontrolled congestive heart failure
- myocardial infarction within the past 6 months
- unstable angina
- uncontrolled hypertension
- pregnant or nursing
- serious bacterial, viral, or fungal infection requiring ongoing treatment
- severe peripheral neuropathy
- poor psychiatric risk
- history of any other known serious co-morbid medical or psychiatric condition
- prior cytotoxic therapy for breast cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Paclitaxel
Paclitaxel given before surgery
|
subjects will receive paclitaxel neoadjuvantly
subjects will have a biopsy to collect tissue for gene microarray analysis
All subjects will have a biopsy to collect tissue
paclitaxel is given neoadjuvantly
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Response
Time Frame: 3 months
|
Due to the early termination of the study, this data for this outcome was not collected.
|
3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Minetta C. Liu, MD, Lombardi Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000368453
- P30CA051008 (U.S. NIH Grant/Contract)
- P50CA058185 (U.S. NIH Grant/Contract)
- GUMC-00310
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