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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00870168
Recruitment Status : Completed
First Posted : March 27, 2009
Last Update Posted : May 16, 2011
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: chemotherapy Genetic: gene expression analysis Other: laboratory biomarker analysis Procedure: breast biopsy Not Applicable

Detailed Description:



  • 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
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Changes in hormone receptor expression

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • No prior first-line treatment for metastatic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00870168

Centre Jean Perrin
Clermont-Ferrand, France, 63011
Sponsors and Collaborators
Centre Jean Perrin
OverallOfficial: Philippe Chollet, MD, PhD Centre Jean Perrin Identifier: NCT00870168     History of Changes
Other Study ID Numbers: CDR0000626717
JEANP-RH Meta Sein
First Posted: March 27, 2009    Key Record Dates
Last Update Posted: May 16, 2011
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
estrogen receptor-negative breast cancer
progesterone receptor-negative breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases