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)

BMC Cancer. 2025 Aug 9;25(1):1295. doi: 10.1186/s12885-025-14673-0.

Abstract

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).

Keywords: Atezolizumab; Capecitabine; Neoadjuvant chemotherapy; Residual disease; Triple negative breast cancer.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Comparative Study

MeSH terms

  • Adult
  • Aged
  • Antibodies, Monoclonal, Humanized* / administration & dosage
  • Antibodies, Monoclonal, Humanized* / adverse effects
  • Antibodies, Monoclonal, Humanized* / therapeutic use
  • Antineoplastic Combined Chemotherapy Protocols* / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols* / therapeutic use
  • Capecitabine* / administration & dosage
  • Capecitabine* / adverse effects
  • Capecitabine* / therapeutic use
  • Chemotherapy, Adjuvant / methods
  • Disease-Free Survival
  • Female
  • Humans
  • Middle Aged
  • Neoadjuvant Therapy / methods
  • Neoplasm Invasiveness
  • Neoplasm, Residual / drug therapy
  • Treatment Outcome
  • Triple Negative Breast Neoplasms* / drug therapy
  • Triple Negative Breast Neoplasms* / mortality
  • Triple Negative Breast Neoplasms* / pathology

Substances

  • Capecitabine
  • Antibodies, Monoclonal, Humanized
  • atezolizumab

Associated data

  • ClinicalTrials.gov/NCT03756298