Utilization of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer (SA02)
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|ClinicalTrials.gov Identifier: NCT00912080|
Recruitment Status : Unknown
Verified March 2013 by Institut Paoli-Calmettes.
Recruitment status was: Active, not recruiting
First Posted : June 3, 2009
Last Update Posted : March 20, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Genetic: genomic signature||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||375 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Utilisation of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer: A Prospective Cohort Study.|
|Study Start Date :||April 2007|
|Estimated Primary Completion Date :||May 2015|
|Estimated Study Completion Date :||May 2015|
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
- 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 ]
- Time between collection for the genomic signature study and the beginning of the chemotherapy. [ Time Frame: 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 ]
- Overall survival. [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912080
|Centre Léon BERARD|
|Centre Antoine LACASSAGNE|
|Principal Investigator:||Jean-Marc EXTRA, MD||Institut Paoli-Calmettes|