Spots Global Cancer Trial Database for Utilization of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer

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Trial Identification

Brief Title: Utilization of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer

Official Title: Utilisation of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer: A Prospective Cohort Study.

Study ID: NCT00912080

Conditions

Breast Cancer

Interventions

genomic signature

Study Description

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.

Detailed Description: