NCT00912080

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
375

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

4 active sites

Status
unknown

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

April 1, 2007

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 3, 2009

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

March 20, 2013

Status Verified

March 1, 2013

Enrollment Period

8.1 years

First QC Date

May 29, 2009

Last Update Submit

March 19, 2013

Conditions

Breast Cancer

Keywords

genomic signaturelymph nodesno metastases

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 years

Secondary Outcomes (3)

  • Time between collection for the genomic signature study and the beginning of the chemotherapy.

    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.

    6 weeks

  • Overall survival.

    5 years

Study Arms (1)

good signature

EXPERIMENTAL

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

Genetic: genomic signature

Interventions

genomic signatureGENETIC

genomic signature analysis

good signature

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Centre Léon BERARD

Lyon, France

Location

Institut PAOLI-CALMETTES

Marseille, France

Location

Centre Antoine LACASSAGNE

Nice, France

Location

Chu Font-Pre

Toulon, France

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jean-Marc EXTRA, MD

    Institut Paoli-Calmettes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2009

First Posted

June 3, 2009

Study Start

April 1, 2007

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

March 20, 2013

Record last verified: 2013-03

Locations

FR(4)