Center of Excellence for Individualization of Therapy for Breast Cancer
Abstract
The report submitted herein includes reports from subcontractors involved in the COE, which explain in detail the efforts of the COE during the past year. This report will highlight the overall progress made by the Center of Excellence. As discussed in a recent teleconference between the COE team and DOD representatives, the past year has seen a significant change in our overall approach to the Center of Excellence for Therapeutic Individualization for Breast Cancer. Our initial approach, as originally set out, involved obtaining frozen tissue samples for all women entering the trial. Obtaining these tissues in a timely fashion proved more difficult than we initially predicted, due to regulatory issues that delayed trial participation and due to accrual problems at clinical sites. Simultaneously, changes in technology have made it possible to perform high-quality analyses on formalin- fixed, paraffin-embedded tissues. We therefore shifted the focus of clinical trial material from fresh frozen tissues to formalin-fixed, paraffin-embedded tissues (FFPET). This shift in focus has had important consequences for trial performance, accrual, and technology. From a trial performance standpoint, we inaugurated during the past year our COE05 trial. This trial, our "Retrospective-Prospective" trial, has obtained FFPET samples from women who have died of metastatic breast cancer and on whom clinical response and time to treatment failure data were available. To date samples from over 60 patients have been obtained. Because patients may have been exposed to more than one chemotherapy regimen during the course of their disease, patients can provide informative data for multiple agents. We are also currently in negotiation with a prominent medical oncology consortium in Poland (headed by Dr. Jacek Jassem) to obtain additional specimens for COE05; at present this consortium has identified 200 patients who are case-eligible for COE05.
Document Details
- Document Type
- Technical Report
- Publication Date
- Apr 01, 2008
- Accession Number
- ADA487228
Entities
People
- George W. Sledge
Organizations
- Indiana University