Status:
TERMINATED
Genetic Testing in Predicting Response to Paclitaxel in Women With Breast Cancer
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 tria...
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 neoa...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00088829
Start Date
April 1 2001
End Date
December 1 2012
Last Update
July 11 2018
Active Locations (1)
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1
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007