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)

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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Main 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, Korean Cancer Study Group (KCSG) Breast Cancer Committee
Format: Article
Language:English
Published: BMC 2025-08-01
Series:BMC Cancer
Subjects:
Triple negative breast cancer
Neoadjuvant chemotherapy
Residual disease
Atezolizumab
Capecitabine
Online Access:https://doi.org/10.1186/s12885-025-14673-0
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Summary: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).
ISSN:1471-2407

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