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)
Year: 2025
Type: article
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).
Source: BMC Cancer
Authors: 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
Institutions: The Catholic University of Korea Seoul St. Mary's Hospital, Catholic University of Korea, Samsung Medical Center, Sungkyunkwan University, Ewha Womans University, Seoul National University, Seoul National University Hospital, National Cancer Center, Ewha Womans University Seoul Hospital, Asan Medical Center, University of Ulsan, Yonsei University, Yonsei Cancer Hospital, Seoul National University Bundang Hospital, Gangnam Severance Hospital, Korea University, Korea University Anam Hospital, Gachon University Gil Medical Center, Inha University, Inha University Hospital, Wonju Severance Christian Hospital, Soonchunhyang University, Soonchunhyang University Hospital Cheonan, Korea University Guro Hospital
Language: English
Subfield: Cancer Research
Domain: Life Sciences
Open Access status: gold
Estimated APC paid: $3,390
Funder: Ministry of Health and Welfare
OpenAlex ID: W4413093996