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New Drug: Sacituzumab govitecan in patients (Pts) with hormone receptor-positive/HER2-negative (HR+/HER2-) advanced breast cancer

New Drug: Sacituzumab govitecan in patients (Pts) with hormone receptor-positive/HER2-negative (HR+/HER2-) advanced breast cancer
Study:
  • Multicenter, randomized, open-label, phase III
  • Unresectable locally advanced or metastatic HR-positive, HER2-negative breast cancer whose disease progressed after a CDK 4/6 inhibitor or endocrine therapy or taxane.
  • Sacituzumab govitecan q21 (n=272) vs TPC (capecitabine, eribulin, vinorelbine, or gemcitabine) (n=271)
Efficacy:
  • mPFS: 5.5 vs.4.0 mos, HR: 0.66, p=0.0003
  • mOS: 13.9 vs. 12.3 mos, HR: 0.84, p=0.143
  • ORR: 21% vs. 14%
Safety:
  • Grade≥3 AEs: Neutropenia (51% vs. 39%), diarrhea (10% vs 1%).

JCO, 2022 (40):17 LBA1001-LBA1001

Rugo S-H et al. ¨ Primary results from TROPiCS-02: A randomized phase 3 study of sacituzumab govitecan (SG) versus treatment of physician’s choice (TPC) in patients (Pts) with hormone receptor–positive/HER2-negative (HR+/HER2-) advanced breast cancer. ¨

http://doi.org/10.1200/JCO.2022.40.17_suppl.LBA1001

Reviewed by Elvin CHALABİYEV, MD on FEB 24, 2023

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