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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:
NCT00912080
First received: May 29, 2009
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

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.

Condition Intervention
Breast Cancer
Genetic: genomic signature

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Utilisation of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer: A Prospective Cohort Study.

Resource links provided by NLM:


Further study details as provided by Institut Paoli-Calmettes:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time between collection for the genomic signature study and the beginning of the chemotherapy. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Overall survival. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 375
Study Start Date: April 2007
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00912080

Locations
France
Centre Léon BERARD
Lyon, France
Institut PAOLI-CALMETTES
Marseille, France
Centre Antoine LACASSAGNE
Nice, France
Chu Font-Pre
Toulon, France
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
Principal Investigator: Jean-Marc EXTRA, MD Institut Paoli-Calmettes
  More Information

Additional Information:
No publications provided

Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT00912080     History of Changes
Other Study ID Numbers: SA02/IPC 2006-003
Study First Received: May 29, 2009
Last Updated: March 19, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Paoli-Calmettes:
genomic signature
lymph nodes
no metastases

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014