Status:
COMPLETED
Studying Biopsy Samples in Women Undergoing First-Line Chemotherapy for Metastatic Breast Cancer
Lead Sponsor:
Centre Jean Perrin
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
RATIONALE: Studying biopsy samples in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This cli...
Detailed Description
OBJECTIVES: Primary * Evaluate the effect of first-line chemotherapy on expression of hormone receptors and biomarkers in women with metastatic breast cancer. Secondary * Assess changes in HER1 an...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the breast
- Metastatic disease
- No inflammatory breast cancer
- Measurable disease according to RECIST criteria
- Hormone receptor status:
- Estrogen receptor- and/or progesterone receptor-negative by IHC
- PATIENT CHARACTERISTICS:
- Menopausal status not specified
- WHO performance status 0-2
- Life expectancy \> 3 months
- ANC \> 1.5 x 10\^9/L
- Platelet count \> 100 x 10\^9/L
- Liver transaminases ≤ 3 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 3 times ULN
- Bilirubin ≤ 1.5 times ULN
- Creatinine ≤ 2 times ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No allergy to xylocaine
- No heart failure, or kidney, bone marrow, respiratory, or liver insufficiency
- PRIOR CONCURRENT THERAPY:
- No prior first-line treatment for metastatic disease
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00870168
Start Date
January 1 2006
Last Update
May 16 2011
Active Locations (1)
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1
Centre Jean Perrin
Clermont-Ferrand, France, 63011