NCT00870168

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Last Updated

May 16, 2011

Status Verified

July 1, 2009

Enrollment Period

5.3 years

First QC Date

March 26, 2009

Last Update Submit

May 13, 2011

Conditions

Breast Cancer

Keywords

stage IV breast cancerestrogen receptor-negative breast cancerprogesterone receptor-negative breast cancer

Outcome Measures

Primary Outcomes (1)

  • Changes in hormone receptor expression

Interventions

chemotherapyDRUG
gene expression analysisGENETIC
laboratory biomarker analysisOTHER
breast biopsyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Drug TherapyGene Expression Profiling

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsGenetic TechniquesInvestigative Techniques

Study Officials

  • Philippe Chollet, MD, PhD

    Centre Jean Perrin

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 26, 2009

First Posted

March 27, 2009

Study Start

January 1, 2006

Primary Completion

May 1, 2011

Last Updated

May 16, 2011

Record last verified: 2009-07

Locations

FR(1)