Halle Moore, MD, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH, details the results of the prospective POSITIVE (NCT02308085) trial which was designed to evaluate the oncologic safety and pregnancy outcomes of interrupting endocrine therapy for hormone responsive breast cancer. The trial enrolled young woman with hormone receptor-positive (HR+) breast cancer who desired a pregnancy and had been taking adjuvant endocrine therapy for 18-36 months. Participants ceased endocrine treatment for at least 3 months prior to attempting pregnancy and were followed for pregnancy and breast cancer-related outcomes. The intent was for patients to be off of endocrine therapy for a 2-year interval whilst attempting to conceive, during pregnancy and when nursing, if desired. The primary endpoint was disease-free interval (DFS). 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 rate of disease-free interval events at 3 years was 8.9%, similar to the event rate observed in the SOFT and TEXT trial, where the disease-free interval event rate was 9.2%. These results confirms that, in the short-term, interrupting endocrine treatment to attempt pregnancy appears to be safe. Additionally, 74% of participants became pregnant at the time of data analysis and 64% of participants had at least one live birth. This interview took place at the San Antonio Breast Cancer Symposium (SABCS) 2022 in San Antonio, TX.
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