Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer: A Systematic Review with Meta-Analysis of

Marcelino Pérez-Bermejo1, Marcelo Mazón-Albalate2, María Teresa Murillo-Llorente1

  • 1SONEV Research Group, Faculty of Medicine and Health Sciences, Catholic University of Valencia San Vicente Mártir, C/Quevedo No. 2, 46001 Valencia, Spain.

Cancers
|June 26, 2026
PubMed
Abstract

Insights

Sacituzumab govitecan (SG) demonstrates significant activity in metastatic triple-negative breast cancer (mTNBC), aligning with both clinical trials and real-world data. This analysis synthesizes evidence to confirm SG

Area of Science:

  • Oncology
  • Clinical Pharmacology
  • Evidence Synthesis

Background:

  • Metastatic triple-negative breast cancer (mTNBC) presents a significant clinical challenge with limited therapeutic options.
  • Sacituzumab govitecan (SG), an antibody-drug conjugate targeting Trop-2, has emerged as a potential treatment.
  • A comprehensive synthesis of randomized and real-world evidence for SG in mTNBC, particularly in diverse patient groups, was needed.

Purpose of the Study:

  • To quantitatively summarize the comparative benefit of sacituzumab govitecan (SG) in metastatic triple-negative breast cancer (mTNBC).
  • To assess the consistency of SG's efficacy observed in clinical trials with its performance in routine clinical practice.
  • To evaluate SG's effectiveness in underrepresented patient subgroups within mTNBC.

Main Methods:

  • Systematic literature review adhering to PRISMA 2020 guidelines, searching PubMed/MEDLINE and Web of Science (January 2017-April 2026).
  • Inclusion of randomized controlled trials and observational cohorts evaluating SG monotherapy in mTNBC.
  • Meta-analysis of single-arm efficacy data (objective response rate, clinical benefit rate, progression-free survival, overall survival) using random-effects models; risk of bias assessment using RoB 2 and ROBINS-I.

Main Results:

  • Nine studies (1242 patients) were included: one randomized trial (ASCENT) and eight real-world studies.
  • In the ASCENT trial, SG significantly improved progression-free survival (PFS) and overall survival (OS) compared to chemotherapy.
  • Pooled real-world data showed objective response rates of 31.1% and median PFS of 4.8 months, consistent with trial findings. Benefit was observed in older patients and Black women but not in those with brain metastases.

Conclusions:

  • Sacituzumab govitecan (SG) exhibits clinically meaningful activity in mTNBC, with consistent efficacy across controlled trials and real-world settings.
  • The comparative advantage of SG over chemotherapy is primarily established by the single ASCENT randomized trial.
  • Pooled single-arm data confirm SG's activity and its consistency in diverse mTNBC patient populations.

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