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Utilization of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer

NCT00912080 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2013-03-20

No results posted yet for this study

Summary

Method: This multicentric prospective cohort is composed of patients with no metastatic breast cancer selected by tumor's genomic analysis and treated by chemotherapy with Anthracycline without Taxanes (6 cycles of FEC 100).

The patient can be included before or after the surgery and a written consent must be signed for the proteomic and genomic analysis of the tumor.

Patients who have a "good signature" for the genomic analysis will receive the standard chemotherapy.

Primary objective:

* To compare metastasis free survival at 5 years in a cohort of patients with no metastatic breast cancer, who are selected by their genomic profile of the tumor and received a standard chemotherapy containing Anthracycline, with result of retrospectives studies.

Secondary Objectives:

* Overall survival.
* Creation of a circuit (transport-extraction-genomic analysis-result) which allows the beginning of the chemotherapy within 6 weeks following the primary surgery.
* Histological and seric proteomic exploratory studies.

Conditions

Interventions

GENETIC

genomic signature

genomic signature analysis

Sponsors & Collaborators

  • Institut Paoli-Calmettes

    lead OTHER

Principal Investigators

  • Jean-Marc EXTRA, MD · Institut Paoli-Calmettes

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00912080 on ClinicalTrials.gov