A new amendment for the IBCSG 18-98 / BIG 1-98 trial is being released in view of translational investigations on formalin-fixed, paraffin-embedded (FFPE) material from BIG 1-98 patients. The translational research planned for the BIG 1-98 material has great potential for improving breast cancer treatments.
IBCSG has completed a program of quality assurance with respect to histologic parameters and endocrine receptors in the years 2005-2006 for patients included in the BIG 1-98 trial. Pathologists at participating sites have provided samples of FFPE tumor material to IBCSG. A central histology review was carried out in the IBCSG Central Pathology Laboratory under the leadership of Prof. G. Viale at the European Institute of Oncology in Milan, Italy. The results have been published and have served to greatly enhance the scientific value of the trial results.
The remaining FFPE material is stored in the IBCSG Tissue Bank at the IBCSG Central Pathology Review office in Milan, Italy. IBCSG is coordinating a program of translational research projects to be carried out with this material. This program will lead towards tailoring the treatment for future patients, by identifying subpopulations with particularly high or low responsiveness to and tolerability of tamoxifen or letrozole. Amendment 6 describes the planned research program and serves to secure the proper patient consent to the translational research program.
The complete documentation has been sent to BIG 1-98 participants and is available in the Members Section.