A Prospective Clinical Trial for Managing Chemotherapeutic Options in Breast Cancer

IpsogenSAS, a French biotechnology company and a group of comprehensive cancer centres leaded by Institut Paoli-Calmettes (IPC) has announced that the clinical trial SA02 is open.

This trial is aimed at studying a genomic signature to predict the likelihood of relapse of node positive breast cancer patients treated with chemotherapy regimen.

The trial concerns 375 women and is planned over a two year period with the primary objective to confirm the results obtained from retrospective studies establishing the correlation between a genomic signature of breast tumors and the chemosensitivity of aggressive breast cancers.

The genomic signature is obtained by using scale gene expression analysis of tumor cells to calculate a risk score from a defined set of genes.

This trial is part of a project, jointly initiated five years ago by IPC and Ipsogen, to bring personalized medicine into routine clinical practice.

“The launch of this first clinical trial is a major milestone for our long term medical and scientific collaboration with Ipsogen. The discovery of a robust gene signature predictive of disease evolution of breast cancer patients under chemotherapy could help physicians identifying the best therapeutic options for each patient.” said Patrice Viens Head of Clinical Research at IPC.

Ipsogen’s CEO, Mr Vincent Fert stated: “We are very pleased to initiate the clinical phase of our breast cancer project in close collaboration with our clinical partners. The gene signature technology we use has been rigorously validated in independent patient cohorts and take advantage of industry standard gene expression devices i.e., Affymetrix® GeneChip® arrays, in order to guarantee state-of-the art analytical performances”.