Olivia Pagani, MD, Institute of Oncology of Southern Switzerland, Ticino, Switzerland, provides an overview of the prospective POSITIVE (NCT02308085) trial designed to evaluate the safety and pregnancy outcomes of interrupting endocrine therapy for hormone-responsive breast cancer. In this subset of woman, the boost of hormones during pregnancy was considered to be dangerous in the past. The trial additionally addressed the concern for woman at risk of being unable to have a pregnancy after the 5-10 years of endocrine therapy. The inclusion criteria included woman who desired a pregnancy and younger than 42 years old and received at least 18 months of endocrine therapy to ensure an effective endocrine treatment prior to attempting pregnancy. The primary endpoint of POSITIVE was disease-free interval. To provide a comparison, participants in the POSITIVE study were matched to participants in the Phase III SOFT (NCT00066690) and TEXT (NCT00066703) clinical trials, which were studies of different endocrine treatment options for premenopausal woman with early breast cancer. The disease-free interval and distant recurrence rates were similar between participants in the POSITIVE trial compared to the SOFT and TEXT trials. Overall, there was no negative effect of interrupting endocrine therapy to attempt a pregnancy. 74% of woman succeeded in getting pregnant and 64% of woman had at least one live birth. Overall, the trial demonstrated interrupting endocrine therapy is safe for woman with breast cancer trying to get pregnant. This interview took place at the San Antonio Breast Cancer Symposium (SABCS) 2022 in San Antonio, TX.
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