Key clinical point: Neoadjuvant endocrine therapy with fulvestrant or anastrozole + fulvestrant led to an endocrine-sensitive disease rate (ESDR) comparable to anastrozole alone in postmenopausal women with estrogen receptor (ER)-rich, human epidermal growth factor receptor 2-negative ( ERBB2−) breast cancer (BC).
Major finding: Both f ulvestrant and anastrozole + fulvestrant vs anastrozole alone demonstrated no significant improvement in the ESDR at 6 months (22.8% and 20.5% vs 18.7%, respectively; Wald test, P ≥ .98) and median percentage change in Ki67 at 4 weeks ( −79.1% and −83.5% vs − 80.6%, respectively; P ≥ .15).
Study details: Findings are from the phase 3 ALTERNATE trial, which included 1298 treatment-naive postmenopausal women with ER-rich/ ERBB2− BC who were randomly assigned to receive anastrozole, fulvestrant, or anastrozole + fulvestrant for 6 months in a neoadjuvant setting.
Disclosures: This study was supported by the US National Institutes of Health (NIH)/National Cancer Institute (NCI) and other sources. Several authors declared receiving grants, personal fees, or research support or having other ties with various sources, including NIH/NCI.
Source: Ma CX, Suman VJ, Sanati S, et al. Endocrine-sensitive disease rate in postmenopausal patients with estrogen receptor-rich/ ERBB2-negative breast cancer receiving neoadjuvant anastrozole, fulvestrant, or their combination: A phase 3 randomized clinical trial. JAMA Oncol. 2024 (Jan 18). doi: 10.1001/jamaoncol.2023.6038 Source