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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00870168
First received: March 26, 2009
Last updated: May 13, 2011
Last verified: July 2009
  Purpose

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 Intervention
Breast Cancer
Drug: chemotherapy
Genetic: gene expression analysis
Other: laboratory biomarker analysis
Procedure: breast biopsy

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Modifications of Hormone Receptors and Biological Parameters of Metastatic Breast Cancer Treated With First-line Chemotherapy. Prospective Biological Study.

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Changes in hormone receptor expression [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2006
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00870168

Locations
France
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Sponsors and Collaborators
Centre Jean Perrin
Investigators
Investigator: Philippe Chollet, MD, PhD Centre Jean Perrin
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00870168     History of Changes
Other Study ID Numbers: CDR0000626717, JEANP-AU-613, INCA-RECF0389, JEANP-RH Meta Sein, PFIZER-JEANP-AU-613
Study First Received: March 26, 2009
Last Updated: May 13, 2011
Health Authority: United States: Federal Government

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
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014