(HealthDay News) — For patients with metastatic breast cancer, personalization of therapy is feasible, according to a study published online Feb. 7 in The Lancet Oncology.

For the SAFIR01 trial, Fabrice André, MD, from INSERM Unit U981 in Paris, and colleagues recruited 423 patients with breast cancer with a metastasis accessible for biopsy from 18 centers. Four hundred seven biopsy samples were assessed using comparative genomic hybridization (CGH) array and Sanger sequencing on PIK3CA and AKT1. Therapeutic targets were selected based on the genomic alterations identified.

The researchers found that CGH array was feasible in 67% of patients, and Sanger sequencing was feasible in 70%. In 46% of patients, a targetable genomic alteration was identified, most frequently in PIK3CA, CCND1, and FGFR1 (25%, 19%, and 13% of identified genomic alterations, respectively). 

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Rare genomic alterations (defined as occurring in less than 5% of the general population) were identified in 39% of patients with genomic tests available. Therapy could be personalized for 13% of the 423 patients (55 patients). Of the 43 patients who received personalized therapy, 9% had an objective response and 21% had stable disease for more than 16 weeks. 

Biopsy-related serious adverse events were reported in four enrolled patients.

“Personalization of medicine for metastatic breast cancer is feasible, including for rare genomic alterations,” the researchers wrote.

RELATED: Molecular Profiling: Personalizing Treatment for Breast Cancer

In an accompanying comment, Charles Swanton, MD, FRCP, PhD, of the Cancer Research UK London Research Institute and UCL Cancer Institute and Hospitals, London, UK, noted the significance of these findings.

“In view of the challenges highlighted by SAFIR01, efforts to accelerate genomic analyses for personalized medicine must continue to be embedded within the context of clinical trials, and integrated with scientific and clinical collaborative structures to deliver measurable benefits to patients. The findings of SAFIR01 represent an important first step on this journey,” he wrote.

Several researchers disclosed financial ties to the pharmaceutical industry.


  1. André F, Bachelot T, Commo F, et al. Comparative genomic hybridisation array and DNA sequencing to direct treatment of metastatic breast cancer: a multicentre, prospective trial (SAFIR01/UNICANCER). Lancet. 2014;doi:10.1016/S1470-2045(13)70611-9.
  2. Swanton C. SAFIR01: steps towards precision treatment in breast cancer. Lancet. 2014;doi:10.1016/S1470-2045(14)70003-8.