NCT00912080

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 375 (estimated)
• Sponsor: Institut Paoli-Calmettes · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
GENETIC	genomic signature	genomic signature analysis

Timeline

• Start date: 2007-04-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2009-06-03
• Last updated: 2013-03-20

Locations

4 sites across 1 country: France