Genetic Testing in Predicting Response to Paclitaxel in Women With Breast Cancer
This study is currently recruiting participants.
Verified June 2012 by Georgetown University
Sponsor:
Georgetown University
Collaborator:
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT00088829
First received: August 4, 2004
Last updated: June 21, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: paclitaxel Genetic: microarray analysis Procedure: biopsy Procedure: neoadjuvant therapy Drug: Paclitaxel |
Phase 2 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Paclitaxel
U.S. FDA Resources
Further study details as provided by Georgetown University:
Primary Outcome Measures:
- Overall response [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2001 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Paclitaxel
Paclitaxel given before surgery
|
Drug: paclitaxel
subjects will receive paclitaxel neoadjuvantly
Genetic: microarray analysis
subjects will have a biopsy to collect tissue for gene microarray analysis
Procedure: biopsy
All subjects will have a biopsy to collect tissue
Procedure: neoadjuvant therapy
paclitaxel is given neoadjuvantly
Drug: Paclitaxel
All patients will receive paclitaxel neoadjuvantly
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00088829
Locations
| United States, District of Columbia | |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Minetta C. Liu, MD 202-444-5537 liumc@georgetown.edu | |
Sponsors and Collaborators
Georgetown University
Investigators
| Principal Investigator: | Minetta C. Liu, MD | Lombardi Cancer Research Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Georgetown University |
| ClinicalTrials.gov Identifier: | NCT00088829 History of Changes |
| Other Study ID Numbers: | CDR0000368453, P50CA058185, P30CA051008, GUMC-00310 |
| Study First Received: | August 4, 2004 |
| Last Updated: | June 21, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Georgetown University:
|
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer |
stage IA breast cancer stage IB breast cancer HER2-negative breast cancer HER2-positive breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Tubulin Modulators |
Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013