A new amendment for the IBCSG 27-02/BIG 1-02/NSABP-37 trial is being released to revise the sample size, permit the use of lapatinib and other HER-2 directed therapies and includes removal of quality of life objectives and quality of life assessments respectively.
When this trial was designed in 2002, conservative assumptions were made concerning potential chemotherapy benefit. Since then, data have emerged from overview analysis, other recently reported trials, and longer-term follow up of combination therapies in the adjuvant and metastatic setting suggesting that the true magnitude of the chemotherapy effect may be larger than specified in the original protocol in the case of IBTR or LRR. We therefore postulate a larger chemotherapy benefit than originally planned, which reduces the total number of patients and number of events required to provide meaningful information on the worth of chemotherapy in this clinical setting.
The complete documentation has been sent to 27-02 participants and is available in the Members Section.