More commonly, it involves the suppression of clinical trial results, especially when they show a drug is no good.
Nevertheless, our review is no exception in that it may have been affected by suppression of negative trial results, or publication bias [ 48].
Two important ongoing randomized phase 3 trials - Suppression of Ovarian Function Trial (SOFT) and Tamoxifen and Exemestane Trial (TEXT) - are evaluating the addition of OvS to tamoxifen and also the role of AIs in pre-menopausal women with ER+ early BC.
This is the subject of several randomized clinical trials, including the Suppression of Ovarian Function Trial (SOFT; NCT00917969).
Two new trials from the International Breast Cancer Study Group TEXTT [Tamoxifen and Exemestane Trial] and SOFT [Suppression of Ovarian Function Trial] [ 2]) will address this issue.
Three important ongoing trials are specifically investigating ovarian function suppression (Suppression of Ovarian Function Trial, or SOFT), an aromatase inhibitor (Tamoxifen and EXemestane Trial, or TEXT), and the need for chemotherapy (Premenopausal Endocrine Responsive CHEmotherapy, or PERCHE) in adjuvant treatment for young patients with hormone receptor-positive breast cancer [ 23].
Although a reasonable alternative to tamoxifen for these women might be an AI in addition to ovarian suppression, no randomized trials have demonstrated equivalence between these two alternatives, although the Suppression of Ovarian Function Trial (SOFT) is currently addressing this question [ 8].
The latter adjusts for publication bias (ie, the suppression of an entire trial depending on results).
BIG, Breast International Group CMFF, cyclophosphamide methotrexate and 5-fluorouracil; HERA, HERceptin® adjuvant; SOFT, Suppression of Ovarian Function Trial; IBCSG, International Breast Cancer Study Group.
The potential benefit of ovarian suppression in addition to tamoxifen for women with hormone receptor-positive breast cancer is currently under active investigation in the Suppression of Ovarian Function Trial.
