Abstract BACKGROUND Assessment of restoration of ovarian function after chemotherapy is critical with respect to the initiation of different types of endocrine treatment in young high risk breast cancer patients METHODS In total, 1289 women who remained premenopausal or resumed premenopausal status after chemotherapy were randomized to receive 5 years of tamoxifen or 5 years of tamoxifen plus 2 years of ovarian suppression. The patients who did not resume menstruation were followed up for 2 years with tamoxifen treatment after finishing chemotherapy. Prospectively collected consecutive post-chemotherapy hormone and menstruation data were available for 705 breast cancer patients who enrolled tamoxifen-only treatment group or did not resume menstruation during follow up. This analysis evaluated the proportion of patients with pre-menopausal FSH levels (<30 mIU/ml), E2 levels (340 pg/ml), and menstruation at any time point during treatment with tamoxifen. RESULTS During 5 years of tamoxifen treatment after chemotherapy for premenopausal breast cancer patients, 62% of patients resumed menstruation. Menstruation returned in 92% of patients under 35 years old but only in 31% of patients over 45 years old. Ovarian function, defined by serum FSH and E2 levels, resumed in 94% and 65% of patients, respectively, over 5 years. Most patients achieved ovarian function restoration during the first 2 years after chemotherapy, with 47.1% resuming menstruation and 86.2% and 50.3% achieving pre-menopausal FSH and E2 levels, respectively, in the first 2 years. Clinical factors related to menstruation restoration were younger age (HR = 6.38, 95% CI 1.33-3.47), 6 month hormone profile after chemotherapy (FSH<30: HR=1.67, 95% CI 1.28-2.17; E2 >40: HR=2.96, 95% CI 2.25-3.89), and anthracycline without taxane chemotherapy (HR=1.63, 95% CI 1.25-2.13). CONCLUSIONS During 5 years of tamoxifen treatment after chemotherapy, half of patients experienced menstruation restoration, including most very young patients under 35 years. The majority of patients experienced menstruation restoration in the first 2 years of tamoxifen treatment. Citation Format: Kim HJ, Noh WC, Nam SJ, Park B-w, Lee ES, Im SA, Jung YS, Yoon JH, Kang SS, Park KH, Lee S-J, Jung J, Lee MH, Cho SH, Kim SY, Kim H-A, Han S-H, Han W, Hur MH, Ahn SH. Time course changes in serum FSH, estradiol, and menstruation restoration in premenopausal patients with breast cancer taking adjuvant tamoxifen after completing chemotherapy: A report from the ASTRRA study [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P4-14-04.