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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2015-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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good signature

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

Group Type EXPERIMENTAL

genomic signature

Intervention Type GENETIC

genomic signature analysis

Interventions

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genomic signature

genomic signature analysis

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* Women aged between 18 and 70
* Patient with life condition \< 2 (WHO scale)
* One-sided breast adenocarcinoma with a histological evidence (all type)
* Clinical presentation which allowed a complete surgery with healthy limits
* Absence of metastasis detectable at clinical examination or radiology
* Histological evidence for homolateral axillary ganglionic invasion, whatever is the number of node invaded (N \> 1)
* The beginning of the chemotherapy within 6 weeks following the primary surgery

Exclusion Criteria

* All metastatic affect
* Tumor classed \>= T4a: cutaneous invasion, deep adherence, inflammatory breast
* All chemotherapy, hormonotherapy or radiotherapy before surgery
* Tumoral residue not removed
* Any suspect clinic or radiologic lesion, in the contralateral breast, which is not controlled
* History of invasive neoplasm, mammary or other (except in situ carcinoma of cervix uteri and epithelioma)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No