Multicenter phase II trial of trastuzumab deruxtecan for HER2-positive unresectable or recurrent biliary tract cancer: HERB trial-Reference-Cited by-同舟云学术

Multicenter phase II trial of trastuzumab deruxtecan for HER2-positive unresectable or recurrent biliary tract cancer: HERB trial

Published:2022-06 Issue:19 Volume:18 Page:2351-2360
ISSN:1479-6694
Container-title:Future Oncology
language:en
Short-container-title:Future Oncology

Author:

Ohba Akihiro¹^ORCID,Morizane Chigusa¹,Ueno Makoto²,Kobayashi Satoshi²,Kawamoto Yasuyuki³^ORCID,Komatsu Yoshito⁴,Ikeda Masafumi⁵,Sasaki Mitsuhito⁵,Okano Naohiro⁶^ORCID,Furuse Junji⁶,Hiraoka Nobuyoshi⁷,Yoshida Hiroshi⁷,Kuchiba Aya⁸,Sadachi Ryo⁸,Nakamura Kenichi⁹,Matsui Naoko⁹,Nakamura Yoshiaki¹⁰,Okamoto Wataru¹¹,Yoshino Takayuki¹⁰,Okusaka Takuji¹

Affiliation:

1. Department of Hepatobiliary & Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan

2. Division of Hepatobiliary & Pancreatic Oncology, Kanagawa Cancer Center, Yokohama, Japan

3. Department of Gastroenterology & Hepatology, Hokkaido University Hospital, Sapporo, Japan

4. Department of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, Sapporo, Japan

5. Department of Hepatobiliary & Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan

6. Department of Medical Oncology, Kyorin University Faculty of Medicine, Tokyo, Japan

7. Division of Pathology & Clinical Laboratories, National Cancer Center Hospital, Tokyo, Japan

8. Biostatistics Section, Clinical Research Support Office, National Cancer Center Hospital/Biostatistics Division, Center for Research Administration & Support, National Cancer Center, Tokyo, Japan

9. Clinical Research Support Office, National Cancer Center Hospital, Tokyo, Japan

10. Department of Gastroenterology & Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan

11. Cancer Treatment Center, Hiroshima University Hospital, Hiroshima, Japan

Abstract

Trastuzumab deruxtecan (DS-8201) is an antibody–drug conjugate composed of a humanized monoclonal anti-HER2 antibody, a cleavable tetrapeptide-based linker and a potent topoisomerase I inhibitor. The drug’s efficacy has been proven in HER2-positive breast and gastric cancers. The rate of HER2 positivity in biliary tract cancer (BTC) has been reported to be 5–20%, and case reports and clinical trials have suggested that HER2 inhibitors might be active in HER2-positive BTC. Here we describe the rationale and design of the phase II HERB trial that will evaluate the efficacy and safety of trastuzumab deruxtecan in patients with HER2-expressing unresectable or recurrent BTC. The primary end point will be the centrally assessed objective response rate in HER2-positive patients.

Funder

Japan Agency for Medical Research and Development

Daiichi Sankyo Company

Publisher

Future Medicine Ltd

Subject

Cancer Research,Oncology,General Medicine

Link

https://www.futuremedicine.com/doi/pdf/10.2217/fon-2022-0214

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