Assessment of Ovarian Function in Phase 3 (Neo)adjuvant Breast Cancer Clinical Trials: A Systematic Evaluation.
Wanyuan Cui, Prudence A Francis, Sherene Loi, Martha Hickey, Catharyn Stern, Lumine Na, Ann H Partridge, Sibylle Loibl, Richard A Anderson, Karla J Hutt, Louise A Keogh, Kelly-Anne Phillips
J Natl Cancer Inst | Published : 2021
BACKGROUND: Loss of ovarian function is a recognized adverse effect of chemotherapy for breast cancer, and of great importance to patients. Little is known about the ovarian toxicity of newer cancer treatments. This study examined whether breast cancer clinical trials include assessment of the impact of trial interventions on ovarian function. METHODS: Eligible trials were phase 3 (neo)adjuvant trials of pharmacologic treatments for breast cancer recruiting between June 2008-October 2019, which included premenopausal women. MEDLINE, EMBASE, Clinicaltrials.gov, EudraCT were searched. Data were extracted from trial publications, protocols, databases, and a survey sent to all trial chairs. Test..View full abstract