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

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

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 and HER2 expression during treatment. OUTLINE: This is a multicenter study. Patients receive 6-9 courses of front-line chemotherapy according to the investigator. Patients with estrogen receptor- and/or progesterone receptor-positive disease receive hormone therapy. Patients undergo biopsy prior to and after completion of chemotherapy for examination of hormone receptors and HER1 and HER2 expression. After completion of study treatment, patients are followed every 6 months for 5 years.

Official Title
-----------------
Modifications of Hormone Receptors and Biological Parameters of Metastatic Breast Cancer Treated With First-line Chemotherapy. Prospective Biological Study.

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: chemotherapy
* Genetic: gene expression analysis
* Other: laboratory biomarker analysis
* Procedure: breast biopsy


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: chemotherapy|nan|
|Genetic: gene expression analysis|nan|
|Other: laboratory biomarker analysis|nan|
|Procedure: breast biopsy|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in hormone receptor expression |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage IV breast cancer, estrogen receptor-negative breast cancer, progesterone receptor-negative breast cancer