Utilization of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer (SA02)

March 19, 2013 updated by: Institut Paoli-Calmettes

Utilisation of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer: A Prospective Cohort Study.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

375

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
      • Lyon, France
        • Centre léon bérard
      • Marseille, France
        • Institut Paoli-Calmettes
      • Nice, France
        • Centre Antoine Lacassagne
      • Toulon, France
        • Chu Font-Pre

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

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: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: good signature
Patients who have a "good signature" for the genomic analysis. They will receive the standard chemotherapy.
Genetic: genomic signature
genomic signature analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Estimation of metastasis free survival at 5 years of the patients who had a good genomic signature. The metastasis free survival is defined by the time between the histological diagnosis of the breast cancer and the apparition of the first metastasis.
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Time between collection for the genomic signature study and the beginning of the chemotherapy.
Time Frame: 6 weeks
6 weeks
Seric and histological proteomic exploratory studies with SELDI-TOF MS to: search correlation with histo-clinical or/and molecular parameter and to identify one or few proteic signature with a prognosis value.
Time Frame: 6 weeks
6 weeks
Overall survival.
Time Frame: 5 years
5 years

Collaborators and Investigators

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

Sponsor

Institut Paoli-Calmettes

Investigators

  • Principal Investigator: Jean-Marc EXTRA, MD, Institut Paoli-Calmettes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

April 1, 2007

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

May 1, 2015

Study Registration Dates

First Submitted

May 29, 2009

First Submitted That Met QC Criteria

June 2, 2009

First Posted (Estimate)

June 3, 2009

Study Record Updates

Last Update Posted (Estimate)

March 20, 2013

Last Update Submitted That Met QC Criteria

March 19, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SA02/IPC 2006-003

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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