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

May 13, 2011 updated by: Centre Jean Perrin

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Changes in hormone receptor expression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Jean Perrin

Investigators

  • Philippe Chollet, MD, PhD, Centre Jean Perrin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

March 26, 2009

First Submitted That Met QC Criteria

March 26, 2009

First Posted (Estimate)

March 27, 2009

Study Record Updates

Last Update Posted (Estimate)

May 16, 2011

Last Update Submitted That Met QC Criteria

May 13, 2011

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000626717
  • JEANP-AU-613
  • INCA-RECF0389
  • JEANP-RH Meta Sein
  • PFIZER-JEANP-AU-613

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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