Phase II study to investigate the efficacy of trastuzumab biosimilar (Herzuma®) plus treatment of physician's choice (TPC) in patients with heavily pretreated HER-2+ metastatic breast cancer (KCSG BR 18-14/KM10B)

Sung Hoon Sim; Jeong Eun Kim; Min Hwan Kim; Yeon Hee Park; Jee Hyun Kim; Koung Jin Suh; Su-Jin Koh; Kyong Hwa Park; Myoung Joo Kang; Mi Sun Ahn; Kyoung Eun Lee; Hee-Jun Kim; Hee Kyung Ahn; Han Jo Kim; Keon Uk Park; Jae Ho Byun; Jin Hyun Park; Gyeong-Won Lee; Keun Seok Lee; Joohyuk Sohn; Kyung Hae Jung; In Hae Park

doi:10.1016/j.breast.2022.08.002

Phase II study to investigate the efficacy of trastuzumab biosimilar (Herzuma®) plus treatment of physician's choice (TPC) in patients with heavily pretreated HER-2+ metastatic breast cancer (KCSG BR 18-14/KM10B)

Breast. 2022 Oct:65:172-178. doi: 10.1016/j.breast.2022.08.002. Epub 2022 Aug 17.

Authors

Sung Hoon Sim¹, Jeong Eun Kim², Min Hwan Kim³, Yeon Hee Park⁴, Jee Hyun Kim⁵, Koung Jin Suh⁵, Su-Jin Koh⁶, Kyong Hwa Park⁷, Myoung Joo Kang⁸, Mi Sun Ahn⁹, Kyoung Eun Lee¹⁰, Hee-Jun Kim¹¹, Hee Kyung Ahn¹², Han Jo Kim¹³, Keon Uk Park¹⁴, Jae Ho Byun¹⁵, Jin Hyun Park¹⁶, Gyeong-Won Lee¹⁷, Keun Seok Lee¹, Joohyuk Sohn³, Kyung Hae Jung², In Hae Park¹⁸

Affiliations

¹ Center for Breast Cancer, National Cancer Center, Goyang, South Korea.
² Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
³ Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.
⁴ Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
⁵ Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.
⁶ Department of Hematology and Oncology, Ulsan University Hospital, Ulsan University College of Medicine, Ulsan, South Korea.
⁷ Division of Oncology/Hematology, Department of Internal Medicine, Korea University College of Medicine, Anam Hospital, Seoul, South Korea.
⁸ Division of Oncology, Department of Internal Medicine, Haeundae Paik Hospital, Inje University College of Medicine, Busan, South Korea.
⁹ Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, South Korea.
¹⁰ Department of Hematology and Oncology, Ewha Womans University Hospital, Seoul, South Korea.
¹¹ Division of Hematology/Medical Oncology, Department of Internal Medicine, Chung-Ang University Hospital, Seoul, South Korea.
¹² Division of Medical Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, South Korea.
¹³ Division of Oncology and Hematology, Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, South Korea.
¹⁴ Division of Hematology/Oncology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, South Korea.
¹⁵ Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
¹⁶ Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, South Korea.
¹⁷ Division of Hematology and Oncology Department of Internal Medicine Gyeongsang National University College of Medicine, Jinju, South Korea.
¹⁸ Division of Oncology/Hematology, Department of Internal Medicine, Korea University College of Medicine, Guro Hospital, Seoul, South Korea. Electronic address: parkih@korea.ac.kr.

Abstract

We investigated the efficacy and safety of a trastuzumab biosimilar, Herzuma®, in combination with treatment of physician's choice (TPC) in patients with HER2+ metastatic breast cancer (MBC) who had failed at least two HER2 directed chemotherapies.

Keywords: Clinical trial; HER2 positive; Metastatic breast cancer; Trastuzumab biosimilar; ctDNA.

Publication types

Clinical Trial, Phase II

MeSH terms

Antineoplastic Combined Chemotherapy Protocols / therapeutic use
Biosimilar Pharmaceuticals* / therapeutic use
Breast Neoplasms* / pathology
Dioxolanes
Female
Humans
Physicians*
Receptor, ErbB-2
Trastuzumab

Substances

Biosimilar Pharmaceuticals
Dioxolanes
pipoxolan
Receptor, ErbB-2
Trastuzumab