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<p>Triple-negative breast cancer (TNBC) is an aggressive subtype with poor prognosis, especially in patients with residual disease post-neoadjuvant chemotherapy. This phase II MIRINAE trial (KCSG-BR18-21) evaluates the efficacy and safety of atezolizumab combined with capecitabine versus capecitabine monotherapy as adjuvant treatment in TNBC patients with residual invasive cancer. The primary endpoint is the 5-year invasive disease-free survival (IDFS) rate. Secondary endpoints include IDFS in PD-L1 positive patients, distant relapse-free survival (DRFS), and overall survival (OS). This study addresses the limitations of KEYNOTE-522 by providing data on post-neoadjuvant therapies, potentially establishing a new standard of care for TNBC.</p><p><b>Trial registration</b> This trial is registered at ClinicalTrials.gov (NCT03756298).</p>

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Randomized, phase II trial to evaluate the efficacy and safety of atezolizumab plus capecitabine adjuvant therapy compared to capecitabine monotherapy for triple receptor-negative breast cancer with residual invasive cancer after neoadjuvant chemotherapy (MIRINAE trial, KCSG-BR18-21)

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年8月9日

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  • Jieun Lee,
  • Hee Kyung Ahn,
  • Kyung-Hun Lee,
  • Kyung Hae Jung,
  • Yeon Hee Park,
  • Sung Hoon Sim,
  • Min Hwan Kim,
  • Jee Hyun Kim,
  • Jee Hung Kim,
  • Kyoung Eun Lee,
  • Kyong Hwa Park,
  • Jihong Bae,
  • Moon Hee Lee,
  • Seungtaek Lim,
  • Han Jo Kim,
  • Dae-Won Lee,
  • Jae Ho Jeong,
  • Ji-Yeon Kim,
  • Jin Seok Ahn,
  • Keun Seok Lee,
  • Joohyuk Sohn,
  • Koung Jin Suh,
  • Yoon Jin Cha,
  • Kabsoo Shin,
  • Sung-Bae Kim,
  • Heejung Chae,
  • Gun Min Kim,
  • Seock-Ah Im,
  • In Hae Park

摘要

Triple-negative breast cancer (TNBC) is an aggressive subtype with poor prognosis, especially in patients with residual disease post-neoadjuvant chemotherapy. This phase II MIRINAE trial (KCSG-BR18-21) evaluates the efficacy and safety of atezolizumab combined with capecitabine versus capecitabine monotherapy as adjuvant treatment in TNBC patients with residual invasive cancer. The primary endpoint is the 5-year invasive disease-free survival (IDFS) rate. Secondary endpoints include IDFS in PD-L1 positive patients, distant relapse-free survival (DRFS), and overall survival (OS). This study addresses the limitations of KEYNOTE-522 by providing data on post-neoadjuvant therapies, potentially establishing a new standard of care for TNBC.

Trial registration This trial is registered at ClinicalTrials.gov (NCT03756298).