Studying Biopsy Samples in Women Undergoing First-Line Chemotherapy for Metastatic Breast Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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 clinical trial is studying biopsy samples in women who are receiving first-line chemotherapy for metastatic breast cancer.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Jean Perrin

Criteria

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