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)
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 capec...
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2025-08-01
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| Series: | BMC Cancer |
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| Online Access: | https://doi.org/10.1186/s12885-025-14673-0 |
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| author | 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 Korean Cancer Study Group (KCSG) Breast Cancer Committee |
| author_facet | 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 Korean Cancer Study Group (KCSG) Breast Cancer Committee |
| author_sort | Jieun Lee |
| collection | DOAJ |
| description | 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). |
| format | Article |
| id | doaj-art-caf1d35f91ff4a06b2bc6e8c9b879ec4 |
| institution | Kabale University |
| issn | 1471-2407 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj-art-caf1d35f91ff4a06b2bc6e8c9b879ec42025-08-20T04:03:06ZengBMCBMC Cancer1471-24072025-08-012511710.1186/s12885-025-14673-0Randomized, 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 Lee0Hee Kyung Ahn1Kyung-Hun Lee2Kyung Hae Jung3Yeon Hee Park4Sung Hoon Sim5Min Hwan Kim6Jee Hyun Kim7Jee Hung Kim8Kyoung Eun Lee9Kyong Hwa Park10Jihong Bae11Moon Hee Lee12Seungtaek Lim13Han Jo Kim14Dae-Won Lee15Jae Ho Jeong16Ji-Yeon Kim17Jin Seok Ahn18Keun Seok Lee19Joohyuk Sohn20Koung Jin Suh21Yoon Jin Cha22Kabsoo Shin23Sung-Bae Kim24Heejung Chae25Gun Min Kim26Seock-Ah Im27In Hae Park28Korean Cancer Study Group (KCSG) Breast Cancer CommitteeDivision of Medical Oncology, Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, Catholic University of KoreaDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of MedicineCancer Research Institute, Seoul National University Hospital, Seoul National University College of MedicineDepartment of Oncology, Asan Medical Center, University of Ulsan College of MedicineDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of MedicineCenter for Breast Cancer, National Cancer CenterDivision of Medical Oncology, Department of Internal Medicine, Yonsei cancer center, Yonsei University College of MedicineDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of MedicineDivision of Medical Oncology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of MedicineDepartment of Hematology and Oncology, Ewha Womans University HospitalDivision of Hemato-Oncology, Department of Internal Medicine, Korea University College of Medicine, Korea University Anam HospitalDivision of Medical Oncology, Department of Internal Medicine, Gachon University Gil Medical CenterDepartment of Internal Medicine, Inha University HospitalDepartment of Hemato-Oncology, Wonju Severance Christian Hospital, Yonsei University Wonju College of MedicineDivision of Oncology and Hematology, Department of Internal Medicine, Soonchunhyang University Cheonan HospitalCancer Research Institute, Seoul National University Hospital, Seoul National University College of MedicineDepartment of Oncology, Asan Medical Center, University of Ulsan College of MedicineDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of MedicineDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of MedicineCenter for Breast Cancer, National Cancer CenterDivision of Medical Oncology, Department of Internal Medicine, Yonsei cancer center, Yonsei University College of MedicineDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of MedicineDepartment of Pathology, Gangnam Severance Hospital, Yonsei University College of MedicineDivision of Medical Oncology, Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, Catholic University of KoreaDepartment of Oncology, Asan Medical Center, University of Ulsan College of MedicineCenter for Breast Cancer, National Cancer CenterDivision of Medical Oncology, Department of Internal Medicine, Yonsei cancer center, Yonsei University College of MedicineCancer Research Institute, Seoul National University Hospital, Seoul National University College of MedicineDivision of Hemato-Oncology, Department of Internal Medicine, Korea University College of Medicine, Korea university Guro HospitalAbstract 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).https://doi.org/10.1186/s12885-025-14673-0Triple negative breast cancerNeoadjuvant chemotherapyResidual diseaseAtezolizumabCapecitabine |
| spellingShingle | 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 Korean Cancer Study Group (KCSG) Breast Cancer Committee 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 Triple negative breast cancer Neoadjuvant chemotherapy Residual disease Atezolizumab Capecitabine |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| topic | Triple negative breast cancer Neoadjuvant chemotherapy Residual disease Atezolizumab Capecitabine |
| url | https://doi.org/10.1186/s12885-025-14673-0 |
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