A new amendment for the IBCSG 25-02/BIG 3-02 (TEXT) trial has been released
The amendment allows an increase in accrual by 600 patients and to include translational investigations for new and already-enrolled patients. Accrual to the trial was suspended on November 30, 2007. In 2008, IBCSG was awarded a major research grant from the Susan G Komen for the Cure Foundation and as a result, recruitment to the trial will be reopened.
With TEXT Amendment 2, new translational investigations are introduced to the protocol. The TEXT trial offers an opportunity to investigate tailoring adjuvant endocrine therapy for premenopausal women. Amendment 2 will expand the established tissue bank to a biospecimen bank by collecting a one-time whole blood sample from all enrolled patients to isolate DNA for specified research and to be stored for unspecified future research.
The effect of endocrine therapies on bone mineral density (BMD) in premenopausal women is not fully understood. The TEXT-Bone substudy for newly-enrolling patients will focus translational investigations on the roles of serial serum markers of bone remodeling as predictors of bone side effects of the TEXT treatments. This substudy will only be conducted in selected centers with a high enough accrual rate to ensure target sample sized is reached.
The complete documentation has been sent to TEXT participants and is available in the Members Section.