Overview

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