Studying Biopsy Samples in Women Undergoing First-Line Chemotherapy for Metastatic Breast Cancer
|ClinicalTrials.gov Identifier: NCT00870168|
Recruitment Status : Completed
First Posted : March 27, 2009
Last Update Posted : May 16, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: chemotherapy Genetic: gene expression analysis Other: laboratory biomarker analysis Procedure: breast biopsy||Not Applicable|
- Evaluate the effect of first-line chemotherapy on expression of hormone receptors and biomarkers in women with metastatic breast cancer.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Official Title:||Modifications of Hormone Receptors and Biological Parameters of Metastatic Breast Cancer Treated With First-line Chemotherapy. Prospective Biological Study.|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||May 2011|
- Changes in hormone receptor expression
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00870168
|Centre Jean Perrin|
|Clermont-Ferrand, France, 63011|
|OverallOfficial:||Philippe Chollet, MD, PhD||Centre Jean Perrin|