A randomized phase III trial of anthracyclines followed by taxane versus taxane plus carboplatin as (neo)adjuvant therapy in patients with triple-negative breast cancer: KCSG BR 15-1 PEARLY trial

G M Kim; K H Jung; H C Jeung; J Lee; K S Lee; S A Im; S Y Kang; S H Kim; H J Kim; K H Park; Y S Chae; S J Koh; E K Cho; K U Park; S S Lee; J Y Kim; I S Choi; S K Baek; Y W Moon; S G Kim; S T Lim; K H Lee; H J Kim; M H Kim; K H Kim; S I Kim; S Park; H S Park; J Y Kim; Y B Kim; S B Kim; J H Ahn; J H Jeong; J H Kim; J Jeong; W C Park; S H Sim; K Lee; C M Nam; S Park; S Paik; J Sohn; Korean Cancer Study Group (KCSG)

doi:10.1016/j.annonc.2026.05.703

A randomized phase III trial of anthracyclines followed by taxane versus taxane plus carboplatin as (neo)adjuvant therapy in patients with triple-negative breast cancer: KCSG BR 15-1 PEARLY trial

Ann Oncol. 2026 May 30:S0923-7534(26)00887-2. doi: 10.1016/j.annonc.2026.05.703. Online ahead of print.

Authors

G M Kim¹, K H Jung², H C Jeung³, J Lee⁴, K S Lee⁵, S A Im⁶, S Y Kang⁷, S H Kim⁸, H J Kim⁹, K H Park¹⁰, Y S Chae¹¹, S J Koh¹², E K Cho¹³, K U Park¹⁴, S S Lee¹⁵, J Y Kim¹⁶, I S Choi¹⁷, S K Baek¹⁸, Y W Moon¹⁹, S G Kim¹⁹, S T Lim²⁰, K H Lee²¹, H J Kim²², M H Kim¹, K H Kim¹, S I Kim²³, S Park²³, H S Park²³, J Y Kim²³, Y B Kim²⁴, S B Kim², J H Ahn², J H Jeong², J H Kim³, J Jeong²⁵, W C Park⁴, S H Sim⁵, K Lee⁶, C M Nam²⁶, S Park²⁷, S Paik²⁸, J Sohn²⁹; Korean Cancer Study Group (KCSG)

Affiliations

¹ Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.
² Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
³ Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
⁴ Division of Medical Oncology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
⁵ Department of Internal Medicine, Center for Breast Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Republic of Korea.
⁶ Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.
⁷ Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, Republic of Korea.
⁸ Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.
⁹ Division of Oncology and Hematology, Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Republic of Korea.
¹⁰ Division of Medical Oncology, Department of Internal Medicine, Korea University Anam Hospital, Seoul, Republic of Korea.
¹¹ Department of Oncology/Hematology, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National University, Daegu, Republic of Korea.
¹² Division of Hematology and Oncology, Department of Internal Medicine, Ulsan University Hospital, Ulsan University College of Medicine, Ulsan, Republic of Korea.
¹³ Division of Medical Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Republic of Korea.
¹⁴ Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, Republic of Korea.
¹⁵ Department of Hematology-Oncology, Inje University Haeundae Paik Hospital, Inje University College of Medicine, Busan, Republic of Korea.
¹⁶ Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
¹⁷ Department of Internal Medicine, Seoul Municipal Boramae Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.
¹⁸ Department of Internal Medicine, Kyung Hee University Hospital, Seoul, Republic of Korea.
¹⁹ Hematology and Oncology, Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea.
²⁰ Department of Hematology and Medical Oncology, Wonju Severance Christian Hospital, Wonju, Republic of Korea.
²¹ Internal Medicine Department, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Republic of Korea.
²² Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.
²³ Department of Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea.
²⁴ Department of Radiation Oncology, Yonsei Cancer Center, Heavy Ion Therapy Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
²⁵ Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
²⁶ Department of Public Health, Graduate School, Yonsei University, Seoul, Republic of Korea.
²⁷ Department of Research Support, Songdang Institute for Cancer Research, Yonsei, University College of Medicine, Seoul, Republic of Korea.
²⁸ Department of Medical Oncology, Severance Biomedical Science Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
²⁹ Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea. Electronic address: oncosohn@yuhs.ac.

PMID: 42218963
DOI: 10.1016/j.annonc.2026.05.703

Abstract

Background: Platinum agents have been shown to increase pathologic complete response (pCR) rates when added to neoadjuvant chemotherapy for triple-negative breast cancer (TNBC). The PEARLY multicenter, randomized, phase III trial investigated the efficacy and safety of adding carboplatin to standard anthracycline-based and taxane chemotherapy for patients with early-stage TNBC in the neoadjuvant or adjuvant settings.

Patients and methods: Patients with stage II or III TNBC were enrolled. Patients received either standard therapy with doxorubicin and cyclophosphamide followed by a taxane (control arm) or carboplatin in addition to a taxane following doxorubicin and cyclophosphamide (carboplatin arm). The primary endpoint was event-free survival (EFS). Secondary endpoints included overall survival (OS), invasive disease-free survival (IDFS), distant recurrence-free survival (DRFS), pCR rate, and safety.

Results: Between January 2016 and June 2020, 868 patients across 22 institutions in the Republic of Korea were randomly assigned to either the control arm or carboplatin arm. At a median follow-up of 57.2 months, carboplatin significantly improved EFS compared with the control [hazard ratio 0.67, 95% confidence interval (CI) 0.49-0.92, P = 0.012]. The 5-year EFS rates increased from 75.1% to 82.3% with an absolute 7.2% difference. Secondary endpoints, including OS, IDFS, and DRFS, showed directionally consistent trends favoring the carboplatin arm, though none reached statistical significance. Grade 3 or higher treatment-related adverse event rates were more frequent in the carboplatin arm (74.7%) than in the control arm (56.7%), driven primarily by hematologic toxicity.

Conclusion: The addition of carboplatin to doxorubicin and cyclophosphamide followed by taxane therapy significantly improved EFS in patients with early-stage TNBC. Despite a higher incidence of grade ≥3 adverse events in the carboplatin arm, no clinically meaningful deterioration in quality of life was observed, supporting a favorable risk-benefit profile for carboplatin incorporation into early TNBC treatment.

Keywords: (neo)adjuvant treatment; PEARLY; carboplatin; triple-negative breast cancer.