Efficacy and Safety of Atezolizumab Plus Capecitabine Adjuvant Therapy for Triple Receptor-Negative Breast Cancer

Summary

This study will enroll patients who received neoadjuvant therapy for TNBC prior to surgery and did not get pCR. Given the relatively poor prognosis for these patients, this population is considered novel therapeutic as adjuvant treatment. Currently, capecitabine monotherapy could be beneficial to this group of patients according to CREATE-X trial results. The investigators are addressing the effect of anti-PD-L1, atezolizumab combined with capecitabine in patients with TNBC who did not get pCR after neoadjuvant chemotherapy compared to capecitabine monotherapy.

Timeline

Start

2019-01-15

Primary completion

2026-12-31

Completion

2027-12-31

Publications

• Im SA, Park K, Koh J, Park C, Jung KH, Lee J, Ahn HK, Lee A, Sim SH, Kim MH, Kim JH, Kim JH, Lee KE, Park KH, Bae J, Lee MH, Lim S, Kim HJ, Lee DW, Jeong JH, Lee KS, Sohn J, Suh KJ, Kim JY, Cha YJ, Moon J, Ock CY, Kim SB, Shin K, Chae H, Kim GM, Lee KH, Park WY, Park YH, Park IH; Korean Cancer Study Group (KCSG) Breast Cancer Committee. Genomic and transcriptomic analyses of residual invasive triple-negative breast cancer after neoadjuvant chemotherapy in the prospective MIRINAE trial (a randomized phase II trial of adjuvant atezolizumab plus capecitabine compared to capecitabine; KCSG-BR18-21). ESMO Open. 2025 Oct;10(10):105804. doi: 10.1016/j.esmoop.2025.105804. Epub 2025 Sep 24.
• Lee J, Ahn HK, Lee KH, Jung KH, Park YH, Sim SH, Kim MH, Kim JH, Kim JH, Lee KE, Park KH, Bae J, Lee MH, Lim S, Kim HJ, Lee DW, Jeong JH, Kim JY, Ahn JS, Lee KS, Sohn J, Suh KJ, Cha YJ, Shin K, Kim SB, Chae H, Kim GM, Im SA, Park IH; 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. 2025 Aug 9;25(1):1295. doi: 10.1186/s12885-025-14673-0.

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