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CompletedNCT00870168Updated May 16, 2011

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

An interventional study of chemotherapy and gene expression analysis in Breast Cancer, sponsored by Centre Jean Perrin. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-16.

Sponsored by Centre Jean Perrin · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • stage IV breast cancer
  • estrogen receptor-negative breast cancer
  • progesterone receptor-negative breast cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 60 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Centre Jean Perrin is the lead sponsor of 55 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Enrollment
60 participants (estimated)

Interventions

  • Drugchemotherapy
  • Geneticgene expression analysis
  • Otherlaboratory biomarker analysis
  • Procedurebreast biopsy
06

What researchers measure

Primary outcomes

  1. Changes in hormone receptor expression

07

Study locations

1 site
  • Centre Jean Perrin
    Clermont-Ferrand, 63011, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00870168
Lead sponsor
Centre Jean Perrin
First posted
Mar 27, 2009
Start date
Jan 2006
Primary completion
May 2011
Last update
May 16, 2011

Study contacts

Philippe Chollet, MD, PhD
Centre Jean Perrin
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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