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 chemothe
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).
Authors
- Jihong Bae (ORCID: https://orcid.org/0000-0002-8518-7016)
- Sung Hoon Sim (ORCID: https://orcid.org/0000-0002-1503-1075)
- Koung Jin Suh (ORCID: https://orcid.org/0000-0002-1881-8738)
- Kyong Hwa Park (ORCID: https://orcid.org/0000-0002-2464-7920)
- Joohyuk Sohn (ORCID: https://orcid.org/0000-0002-2303-2764)
- Dae‐Won Lee (ORCID: https://orcid.org/0000-0001-7133-6669)
- Kabsoo Shin (ORCID: https://orcid.org/0000-0002-6709-0894)
- Keun Seok Lee (ORCID: https://orcid.org/0000-0001-5575-836X)
- In Hae Park (ORCID: https://orcid.org/0000-0001-7894-8772)
- Yoon Jin (ORCID: https://orcid.org/0000-0002-5967-4064)
- Jae‐Ho Jeong (ORCID: https://orcid.org/0000-0002-5544-9572)
- Kyung Hae Jung (ORCID: https://orcid.org/0000-0002-1580-7224)
- Jee Hung Kim (ORCID: https://orcid.org/0000-0002-9044-8540)
- Min Hwan Kim (ORCID: https://orcid.org/0000-0002-1595-6342)
- Hee Kyung Ahn (ORCID: https://orcid.org/0000-0001-7786-7233)
- Gun Min Kim (ORCID: https://orcid.org/0000-0001-9167-8682)
- Jieun Lee (ORCID: https://orcid.org/0000-0002-2656-0650)
- Han Jo Kim (ORCID: https://orcid.org/0000-0002-5721-1728)
- Jiyeon Kim (ORCID: https://orcid.org/0000-0001-7964-5060)
- Jee Hyun Kim (ORCID: https://orcid.org/0000-0003-1336-3620)
- Yeon Hee Park (ORCID: https://orcid.org/0000-0003-4156-9212)
- Kyoung Eun Lee (ORCID: https://orcid.org/0000-0003-1596-8666)
- Seungtaek Lim (ORCID: https://orcid.org/0000-0001-7258-2263)
- Kyung-Hun Lee (ORCID: https://orcid.org/0000-0002-2390-3240)
- Heejung Chae (ORCID: https://orcid.org/0000-0003-3547-3521)
- Moon Hee Lee (ORCID: https://orcid.org/0000-0002-5965-1815)
- Jin Seok Ahn
- Seock Ah Im
- Sung-Bae Kim
Institutions
- Ulsan College (KR)
- Ewha Womans University (KR)
- Yonsei University (KR)
- Soonchunhyang University (KR)
- Korea University Medical Center (KR)
- Asan Medical Center (KR)
- Samsung Medical Center (KR)
- Seoul National University Hospital (KR)
- Seoul National University Bundang Hospital (KR)
- University of Ulsan (KR)
- Gachon University Gil Medical Center (KR)
- Wonju Severance Christian Hospital (KR)
- National Cancer Center (KR)
- Gangnam Severance Hospital (KR)
- Inha University Hospital (KR)
- The Catholic University of Korea Seoul St. Mary's Hospital (KR)
- Korea University (JP)
- Sungkyunkwan University (KR)
Publication Details
- Journal
- BMC Cancer
- Published
- 2025-08-09
- DOI
- https://doi.org/10.1186/s12885-025-14673-0
- Primary Topic
- Breast Cancer Treatment Studies
- Type
- article
- Field-Weighted Citation Impact
- 0.00