Abstract Background: Central nervous system (CNS) metastases, including brain metastases (BMs) and leptomeningeal disease (LMD), occur in approximately 20%-40% of patients (pts) with breast cancer during the course of their disease. Triple-negative breast cancer (TNBC) is associated with a high incidence of BMs (up to 34%) and poor survival rates. Sacituzumab Govitecan (SG) has demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS) in pre-treated pts with metastatic TNBC (mTNBC) in the pivotal ASCENT trial. However, data on SG efficacy in pts with TNBC and CNS metastases are limited, as only 32 pts with stable/treated BMs were enrolled in the study, and patients with active BMs or LMD were excluded. This study aimed to provide further insight into the clinical activity of SG in pts with mTNBC and CNS involvement. Methods: Clinical and treatment data of pts with TNBC and BMs who were treated in a real-life setting were retrospectively collected from 14 Italian centers as part of a multicenter, observational study (NCT02284581). CNS treatment response was retrospectively categorized as objective response, stable disease, or progressive disease. Real-world (rw)PFS, rwOS, and CNS-specific progression-free survival (CNS-PFS) were described using the Kaplan-Meier method and reported with a 95% confidence interval. Survival outcomes between groups were compared by log-rank tests. Analysis was carried out with R software (version 4.5.1). Results: A total of 54 pts were included in the analysis. Of these, 46 (85.2%) had treated/stable CNS metastases, 4 (7.4%) had active CNS metastases, and 4 (7.4%) had LMD. The median age at SG initiation was 54 years (range: 31-75). The median time from mTNBC diagnosis to CNS metastasis was 12 months, and the median time from CNS metastasis diagnosis to SG initiation was 5 months. Pts had received a median of 2 prior lines of therapy before CNS involvement. At a median follow-up of 18.2 months, the median rwPFS was 3.75 months (95% CI, 3.06-7.89 months) and the median rwOS was 9.49 months (95% CI, 6.21-15.3). The CNS objective response rate (ORR) was 19.6% among pts with treated/stable BMs, and 25% in both pts with active BMs and those with LMD. The median CNS-PFS in the overall population was 9.26 months (range: 4.8-16.2), with subgroup medians of 12.1 months for stable/treated BMs, 4.8 months for active BMs, and 4.1 months for LMD. The table provides a summary of the efficacy results. Conclusion: To our knowledge, this study represents the largest real-world analysis to date assessing the activity of SG in pts with TNBC and CNS metastases. Our findings are consistent with the efficacy profile observed in the ASCENT trial. These data support the potential role of SG in this difficult-to-treat population, although further studies are warranted to better characterize its activity in pts with mTNBC and CNS involvement. Citation Format: R. Caputo, M. Piezzo, C. Martinelli, G. Di Mauro, V. Granata, M. Pagliuca, A. Botticelli, F. Pantano, F. Giotta, A. Diana, L. S. Stucci, N. Staropoli, S. Turano, E. Bajardi, G. Pernice, M. V. Sanò, A. Caltavituro, L. Orlando, S. Scagnoli, C. De Angelis, A. Fabi, G. Buono, M. De Laurentiis. Real-world outcomes with sacituzumab govitecan in patients with triple-negative breast cancer and central nervous system metastases abstract. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS5-03-15.
Caputo et al. (Tue,) studied this question.
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