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Background <p>Metastatic metaplastic triple-negative breast cancer (mMpTNBC) is a rare, aggressive subtype with poor responsiveness to standard therapies. Sacituzumab govitecan (SG) is effective in metastatic TNBC (mTNBC), but data in mMpTNBC are limited to case reports. Patients and methods: This multinational, multicenter, retrospective case series was conducted within the CEBCC-102 real-world evidence project across 18 cancer centers. Female patients with histologically confirmed mMpTNBC treated with ≥ 2L SG outside of clinical trials in Poland, the Czech Republic and Slovakia between August 2021 and June 2025 were included. Clinical data, treatment outcomes, and adverse events (AEs) were collected from medical records and analysed.</p> Results <p>Among 303 patients with mTNBC treated with SG in second and later lines within the CEBCC-102 project, 13 women (4.3%) had mMpTNBC and were included in this analysis. Median age was 58&#xa0;years. PD-L1 CPS ≥ 10 was found in 83% of tested cases. Overall response rate was 36.4%, clinical benefit rate 45.5%, median progression-free survival 3.2&#xa0;months and median overall survival 8.9&#xa0;months. Neutropenia (N = 9, 69%) was the most common AE; no febrile neutropenia or treatment discontinuations due to toxicity occurred.</p> Conclusions <p>This first international real-world series of SG in mMpTNBC shows clinically relevant activity and manageable toxicity, addressing a critical evidence gap and supporting further prospective studies, particularly in PD-L1–positive disease.</p>

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Efficacy and safety of sacituzumab govitecan in patients with metastatic metaplastic triple-negative breast cancer: a multinational retrospective case series from CEBCC-102 study

  • 期刊论文

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  • 发表日期：

    2025年12月9日

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  • Justyna Żubrowska,
  • Małgorzata Pieniążek,
  • Anna Polakiewicz-Gilowska,
  • Miroslava Malejčíková,
  • Miloš Holánek,
  • Renáta Soumarová,
  • Aleksandra Konieczna,
  • Iwona Danielewicz,
  • Maja Lisik-Habib,
  • Aleksandra Łacko,
  • Marcin Kubeczko,
  • Renata Pacholczak-Madej,
  • Zuzana Bielčiková,
  • Mirosława Püsküllüoğlu

摘要

Background

Metastatic metaplastic triple-negative breast cancer (mMpTNBC) is a rare, aggressive subtype with poor responsiveness to standard therapies. Sacituzumab govitecan (SG) is effective in metastatic TNBC (mTNBC), but data in mMpTNBC are limited to case reports. Patients and methods: This multinational, multicenter, retrospective case series was conducted within the CEBCC-102 real-world evidence project across 18 cancer centers. Female patients with histologically confirmed mMpTNBC treated with ≥ 2L SG outside of clinical trials in Poland, the Czech Republic and Slovakia between August 2021 and June 2025 were included. Clinical data, treatment outcomes, and adverse events (AEs) were collected from medical records and analysed.

Results

Among 303 patients with mTNBC treated with SG in second and later lines within the CEBCC-102 project, 13 women (4.3%) had mMpTNBC and were included in this analysis. Median age was 58 years. PD-L1 CPS ≥ 10 was found in 83% of tested cases. Overall response rate was 36.4%, clinical benefit rate 45.5%, median progression-free survival 3.2 months and median overall survival 8.9 months. Neutropenia (N = 9, 69%) was the most common AE; no febrile neutropenia or treatment discontinuations due to toxicity occurred.

Conclusions

This first international real-world series of SG in mMpTNBC shows clinically relevant activity and manageable toxicity, addressing a critical evidence gap and supporting further prospective studies, particularly in PD-L1–positive disease.