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 (TNBC) with residual invasive cancer after neoadjuvant chemotherapy (MIRINAE trial, KCSG-BR18-21).

Authors

null

In Hae Park

Division of Hemato-Oncology, Department of Internal Medicine, Korea University College of Medicine, Guro Hospital, Seoul, South Korea

In Hae Park , Gun Min Kim , Jee Hyun Kim , Hanjo Kim , Kyong Hwa Park , Yeon Hee Park , Sun Kyung Baek , Sung Hoon Sim , Hee Kyung Ahn , Gyeong-Won Lee , Kyoung Eun Lee , Ji Eun Lee , Seungtaek Lim , Kyung Hae Jung , Seock-Ah Im

Organizations

Division of Hemato-Oncology, Department of Internal Medicine, Korea University College of Medicine, Guro Hospital, Seoul, South Korea, Yonsei University Health System Severance Hospital, Seoul, South Korea, Division of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea, Soonchunhyang University Hospital Cheonan, Cheonan, South Korea, Division of Oncology and Hematology, Department of Internal Medicine, Korea University Anam Hospital, Seoul, South Korea, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea, Yeongun Dong Jogno Gu, Kyunggt, South Korea, National Cancer Center, Goyang, South Korea, Gachon University Gil Medical Center, Incheon, South Korea, Division of Hematology and Oncology, Department of Internal medicine, Gyeongsang National University Hospital, Gyeongsang National University College of Medicine, Institute of Health Science, Jinju, South Korea, Department of Hematology and Oncology, Ewha Womans University School of Medicine, Seoul, South Korea, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, South Korea, Department of Hematology-Oncology, Wonju Severance Christian Hospital, Seoul, South Korea, Department of Oncology, University of Ulsan, College of Medicine, Asan Medical Center, Seoul, South Korea, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea

Research Funding

Pharmaceutical/Biotech Company
Roche Korea

Background: Triple negative breast cancer (TNBC), lack of ER, PR and HER2 expression, is known to have aggressive clinical features such as early recurrence, drug resistance, and frequent distant metastasis at the diagnosis. The most effective chemotherapy combinations used for early TNBC include anthracycline, taxanes, and/or platinum agents. Achieving a pathologic complete response (pCR) after neoadjuvant chemotherapy (NAC) provides important prognostic information and is considered as a surrogate endpoint in many clinical trials especially with TNBC. Patients with residual invasive disease after NAC have a high risk for early relapse and worse prognosis compared to those with pCR. Therefore, patients who did not get pCR could be better candidates for additional adjuvant treatment because their risk of recurrence would be higher than those with pCR. The CREATE-X (capecitabine for residual cancer as adjuvant therapy) trial howed that adjuvant capecitabine treatment improved 5-yr rate of disease free survival in TNBC subtype. A recent study indicated that immunosuppressive microenvironment had developed even in early stage of TNBC with increased T cells with a high exhaustion signature which are targets of immune modulating agents. Therefore, earlier cooperation of immune modulating drugs would be beneficial by generating a long-lasting anti-tumor immune response to micrometastatic disease, thus preventing disease relapse or recurrence. Methods: This study is a phase II, multicenter, randomized open label trial of atezolizumab (anti-PD-L1 antibody) and capecitabine compared with capecitabine in patients with TNBC who had residual disease after NAC. 284 patients will be enrolled from 15 sites in Korea with a primary objective to access the 5-yr invasive disease-free survival (IDFS) rate. Secondary objectives include 5-yr IDFS rate in PD-L1 positive population, distant relapse free survival (DRFS), overall survival (OS), and safety. Major inclusion and exclusion criteria are followings; 1) histologically confirmed TNBC, 2) received anthracycline and taxane based NAC followed by complete breast surgery, 3) residual disease after NAC must be ≥1cm in the greatest dimension, and/or have macroscopically positive lymph nodes. The study is open with 13 patients enrolled at the time of submission. Clinical trial information: NCT03756298.

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Abstract Details

Meeting

2020 ASCO Virtual Scientific Program

Session Type

Poster Session

Session Title

Breast Cancer—Local/Regional/Adjuvant

Track

Breast Cancer

Sub Track

Adjuvant Therapy

Clinical Trial Registration Number

NCT03756298

Citation

J Clin Oncol 38: 2020 (suppl; abstr TPS597)

DOI

10.1200/JCO.2020.38.15_suppl.TPS597

Abstract #

TPS597

Poster Bd #

89

Abstract Disclosures