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)
OncologiaResumo original em inglês
O que aconteceu
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).
Resumo publicado sob licença CC BY. A tradução para o português ainda não chegou a este estudo.
O estudo original
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, 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 et al.
Descritores MeSH
- Capecitabine
- Antineoplastic Combined Chemotherapy Protocols
- Antibodies, Monoclonal, Humanized
- Triple Negative Breast Neoplasms
- Female
- Humans
- Middle Aged
- Neoplasm Invasiveness
- Treatment Outcome
- Chemotherapy, Adjuvant