Utilization of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer (SA02)
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.
- 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.
- 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 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.|
- 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 ]
- 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 ]
|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)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00912080
|Centre Léon BERARD|
|Centre Antoine LACASSAGNE|
|Principal Investigator:||Jean-Marc EXTRA, MD||Institut Paoli-Calmettes|