Clinical Trial

. 2025 Aug 9;25(1):1295.

doi: 10.1186/s12885-025-14673-0.

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)

Jieun Lee^#¹, Hee Kyung Ahn^#², Kyung-Hun Lee³, Kyung Hae Jung⁴, Yeon Hee Park², Sung Hoon Sim⁵, Min Hwan Kim⁶, Jee Hyun Kim⁷, Jee Hung Kim⁸, Kyoung Eun Lee⁹, Kyong Hwa Park¹⁰, Jihong Bae¹¹, Moon Hee Lee¹², Seungtaek Lim¹³, Han Jo Kim¹⁴, Dae-Won Lee³, Jae Ho Jeong⁴, Ji-Yeon Kim², Jin Seok Ahn², Keun Seok Lee⁵, Joohyuk Sohn⁶, Koung Jin Suh⁷, Yoon Jin Cha¹⁵, Kabsoo Shin¹, Sung-Bae Kim⁴, Heejung Chae⁵, Gun Min Kim⁶, Seock-Ah Im³, In Hae Park¹⁶; Korean Cancer Study Group (KCSG) Breast Cancer Committee

Affiliations

¹ Division of Medical Oncology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, Catholic University of Korea, Seoul, 06591, Korea.
² Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 06351, Korea.
³ Cancer Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, 03080, Korea.
⁴ Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, 05505, Korea.
⁵ Center for Breast Cancer, National Cancer Center, Goyang, 10408, Korea.
⁶ Division of Medical Oncology, Department of Internal Medicine, Yonsei cancer center, Yonsei University College of Medicine, Seoul, 03722, Korea.
⁷ Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, 13620, Korea.
⁸ Division of Medical Oncology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, 06273, Korea.
⁹ Department of Hematology and Oncology, Ewha Womans University Hospital, Seoul, 07985, Korea.
¹⁰ Division of Hemato-Oncology, Department of Internal Medicine, Korea University College of Medicine, Korea University Anam Hospital, Seoul, 02841, Korea.
¹¹ Division of Medical Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, 21565, Korea.
¹² Department of Internal Medicine, Inha University Hospital, Incheon, 22332, Korea.
¹³ Department of Hemato-Oncology, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, 26426, Korea.
¹⁴ Division of Oncology and Hematology, Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, 31151, Korea.
¹⁵ Department of Pathology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
¹⁶ Division of Hemato-Oncology, Department of Internal Medicine, Korea University College of Medicine, Korea university Guro Hospital, Seoul, 08308, Korea. parkih@korea.ac.kr.

^# Contributed equally.

PMID: 40783751
PMCID: PMC12335778
DOI: 10.1186/s12885-025-14673-0

Clinical Trial

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)

Jieun Lee et al. BMC Cancer. 2025.

. 2025 Aug 9;25(1):1295.

doi: 10.1186/s12885-025-14673-0.

Authors

Affiliations

¹ Division of Medical Oncology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, Catholic University of Korea, Seoul, 06591, Korea.
² Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 06351, Korea.
³ Cancer Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, 03080, Korea.
⁴ Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, 05505, Korea.
⁵ Center for Breast Cancer, National Cancer Center, Goyang, 10408, Korea.
⁶ Division of Medical Oncology, Department of Internal Medicine, Yonsei cancer center, Yonsei University College of Medicine, Seoul, 03722, Korea.
⁷ Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, 13620, Korea.
⁸ Division of Medical Oncology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, 06273, Korea.
⁹ Department of Hematology and Oncology, Ewha Womans University Hospital, Seoul, 07985, Korea.
¹⁰ Division of Hemato-Oncology, Department of Internal Medicine, Korea University College of Medicine, Korea University Anam Hospital, Seoul, 02841, Korea.
¹¹ Division of Medical Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, 21565, Korea.
¹² Department of Internal Medicine, Inha University Hospital, Incheon, 22332, Korea.
¹³ Department of Hemato-Oncology, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, 26426, Korea.
¹⁴ Division of Oncology and Hematology, Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, 31151, Korea.
¹⁵ Department of Pathology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
¹⁶ Division of Hemato-Oncology, Department of Internal Medicine, Korea University College of Medicine, Korea university Guro Hospital, Seoul, 08308, Korea. parkih@korea.ac.kr.

^# Contributed equally.

PMID: 40783751
PMCID: PMC12335778
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.

PubMed Disclaimer

Conflict of interest statement

Declarations. Ethics approval and consent to participate: The study was conducted in compliance with the principles of good clinical practice, adhering to the International Conference on Harmonization guidelines and the ethical principles outlined in the Declaration of Helsinki. Approval for the study was obtained from independent ethics committees or institutional review boards at each participating site (Korea University Guro Hospital IRB number 2019GR0421), and all patients provided written informed consent before participating. Consent for publication: NA. Competing interests: The authors declare no competing interests.

Figures

See this image and copyright information in PMC

References

1. Dent R, Trudeau M, Pritchard KI, et al. Triple negative breast cancer: clinical features and patterns of recurrence. Clin Cancer Res. 2007;13:4429–34. - PubMed
1. Cortazar P, Zhang L, Untch M, et al. Pathological complete response and long term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet. 2014;384:164–72. - PubMed
1. Liedtke C, Mazouni C, Hess K, et al. Response to neoadjuvant therapy and long-term survival in patients with triple negative breast cancer. J Clin Oncol. 2008;26:1275–81. - PubMed
1. Loibl S, Andre F, Bachelot T et al. Early breast cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up. Ann Oncol. 2024;35(2):159–82. - PubMed
1. Gradishar W, Moran M, Abraham J, et al. NCCN guidelines^® insights: breast cancer, version 4.2023. J Natl Compr Canc Netw. 2023;21(6):594–608. - PubMed

Publication types

Actions
Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Substances

Actions
Actions
Actions

Associated data

Actions
- Search in PubMed
- Search in ClinicalTrials.gov

Grants and funding

RS-2022-CC127320/Ministry of Health and Welfare, Republic of Korea

LinkOut - more resources

Full Text Sources
- BioMed Central
- PubMed Central
Medical
- ClinicalTrials.gov
Research Materials
- NCI CPTC Antibody Characterization Program

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

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)

Affiliations

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)

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Substances

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Medical

Research Materials