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

May 29, 2009
March 19, 2013
April 2007
May 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00912080 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Utilization of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer
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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Breast Cancer
Genetic: genomic signature
genomic signature analysis
Experimental: good signature
Patients who have a "good signature" for the genomic analysis. They will receive the standard chemotherapy.
Intervention: Genetic: genomic signature
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
375
May 2015
May 2015   (final data collection date for primary outcome measure)

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)
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00912080
SA02/IPC 2006-003
No
Institut Paoli-Calmettes
Institut Paoli-Calmettes
Not Provided
Principal Investigator: Jean-Marc EXTRA, MD Institut Paoli-Calmettes
Institut Paoli-Calmettes
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP