Correction to: Trastuzumab, pertuzumab, and eribulin mesylate versus trastuzumab, pertuzumab, and a taxane as a first-line or second-line treatment for HER2-positive, locally advanced or metastatic breast cancer: study protocol for a randomized controlled, non-inferiority, phase III trial in Japan (JBCRG-M06/EMERALD)

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Abstract

Correction to: Trials (2020) 21:391 https://doi.org/10.1186/s13063-020-04341-y Following publication of the original article [1], the authors identified an error in Fig. 1, due to the change of the study protocol version (from 1.1 to 2.0). The following points in Fig. 1 need to be changed: - The end of the registration period will be extended from April 2020 to December 2020. - The duration of registration period will be changed from 33 to 41 months. - The end of the follow-up period will be extended from April 2022 to December 2022. - The end of the survival survey will be extended from October 2023 to June 2024. The same changes apply to the text as well, as follows: Trial Status section - This study opened for recruitment in August 2017, with recruitment expected to be completed by December 2020. The first patient was enrolled in October 2017, and the actual number of patients recruited as of January 31, 2020 was 244. - The current protocol is version 2.0 and was approved on November 5, 2019. Because of delayed registration, the registration and follow-up period for OS will be until December 2020 and June 2024., respectively. Follow-up section - All participants will be followed up until December 2022, i.e., 2 years after the last participant recruitment. The correct Fig. 1 is presented below: Fig. 1 Study design flowchart

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Trastuzumab, pertuzumab, and eribulin mesylate versus trastuzumab, pertuzumab, and a taxane as a first-line or second-line treatment for HER2-positive, locally advanced or metastatic breast cancer: study protocol for a randomized controlled, non-inferiority, phase III trial in Japan (JBCRG-M06/EMERALD)

Toshinari Yamashita, Norikazu Masuda, Shigehira Saji … (2020)

Background Trastuzumab (Tmab), pertuzumab (Pmab), and taxane has been a standard first-line treatment for recurrent or metastatic human epidermal growth factor (HER2)-positive breast cancer (HER2+ mBC) but has some safety issues due to taxane-induced toxicities. This has led to ongoing efforts to seek less toxic alternatives to taxanes that are equally effective when used in combination with Tmab plus Pmab. This study aims to show the non-inferiority of eribulin, a non-taxane microtubule inhibitor, against taxane, as a partner for dual HER2 blockade. Methods/design This multicenter, randomized, open-label, parallel-group, phase III study will involve a total of 480 Japanese women with HER2+ mBC who meet the following requirements: (1) age 20–70 years; (2) no prior cytotoxic chemotherapy (excluding trastuzumab-emtansine) for mBC; (3) ≥ 6 months after prior neoadjuvant or adjuvant cytotoxic chemotherapy; (4) presence of any radiologically evaluable lesion; (5) left ventricular ejection fraction ≥ 50%; (6) Eastern Cooperative Oncology Group performance status score of 0 or 1; (7) adequate organ function; and (8) life expectancy of at least 6 months. They will be randomized 1:1 to receive eribulin (1.4 mg/m2 on days 1 and 8) or taxane (docetaxel 75 mg/m2 on day 1 or paclitaxel 80 mg/m2 on days 1, 8, and 15) in combination with Tmab (8 mg/kg then 6 mg/kg) plus Pmab (840 mg then 420 mg) on day 1 of each 21-day cycle. The treatment will be continued until disease progression or unmanageable toxicity. The primary endpoint is progression-free survival as per investigator according to RECIST v1.1 criteria. Key secondary endpoints include objective response rate, overall survival, quality of life and safety. Non-inferiority will be tested with two margins of 1.33 and 1.25 in a stepwise manner. If non-inferiority is shown with a margin of 1.25, superiority will then be tested. Discussion If this study shows the non-inferiority, or even superiority, of Tmab, Pmab, and eribulin against the existing taxane-containing regimen, this new regimen may become a standard first- or second-line treatment option for HER2+ mBC in Japan. Trial registration ClinicalTrials.gov, ID: NCT03264547. Registered on 28 June 2017.

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Contributors

Toshinari Yamashita: tyamashita@kcch.jp

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 8 June 2020

Publication date PMC-release: 8 June 2020

Publication date Collection: 2020

Volume: 21

Electronic Location Identifier: 503

Affiliations

[1 ]GRID grid.414944.8, ISNI 0000 0004 0629 2905, Department of Breast Surgery, , Kanagawa Cancer Center, ; 2-3-2 Nakao, Asahi-ku, Yokohama-shi, Kanagawa 241-8515 Japan

[2 ]GRID grid.416803.8, ISNI 0000 0004 0377 7966, Department of Surgery, Breast Oncology, , National Hospital Organization Osaka National Hospital, ; 2-1-14 Hoenzaka, Chuou-ku, Osaka, 540-0006 Japan

[3 ]Department of Medical Oncology, Fukeushima Medical University, 1 Hikarigaoka Fukushima, Fukushima, 960-1295 Japan

[4 ]Department of Breast Surgery, Gunma Prefectural Cancer Center, 617-1 Takahayashinishicho, Ota, Gunma 373-8550 Japan

[5 ]GRID grid.486756.e, ISNI 0000 0004 0443 165X, Breast Medical Oncology, Breast Oncology Center, , The Cancer Institute Hospital of JFCR, ; 3-8-31 Ariake Koto-ku, Tokyo, 135-8550 Japan

[6 ]GRID grid.410813.f, ISNI 0000 0004 1764 6940, Department of Medical Oncology, , Toranomon Hospital, ; 2-2-2 Toranomon, Minato-ku, Tokyo, 105-8470 Japan

[7 ]GRID grid.415270.5, Breast Surgery, , NHO Hokkaido Cancer Center, ; 2-3-54 Yonjyo Kikusui Shiraishi-ku, Sapporo-shi, Hokkaido 003-0804 Japan

[8 ]GRID grid.412812.c, ISNI 0000 0004 0443 9643, Department of Medical Oncology, , Showa University Hospital, ; 1-5-8 Hatanodai Shinagawa-ku, Tokyo, 142-8666 Japan

[9 ]GRID grid.505613.4, First Department of Surgery, , Hamamatsu University School of Medicine, ; 1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka 431-3192 Japan

[10 ]GRID grid.252427.4, ISNI 0000 0000 8638 2724, Breast Disease Center, , Asahikawa Medical University Hospital, ; 1-1 Higashi 2-jyo 1-chome, Midorigaoka, Asahikawa-shi, Hokkaido 078-8510 Japan

[11 ]GRID grid.412764.2, ISNI 0000 0004 0372 3116, Department of Breast Surgery, , St. Marianna University School of Medicine Hospital, ; 2-16-1 Sugao Miyamae-ku, Kawasaki-shi, Kanagawa 216-8511 Japan

[12 ]Breast Surgical Oncology, Sagara Hospital, 3-31 Matsubaracho Kagoshima-shi, Kagoshima, 892-0833 Japan

[13 ]GRID grid.412757.2, ISNI 0000 0004 0641 778X, Department of Breast and Endocrine Surgical Oncology, , Tohoku University Hospital, ; 1-1 Seiryocho Aoba-ku, Sendai-shi, Miyagi 980-8574 Japan

[14 ]GRID grid.413111.7, ISNI 0000 0004 0466 7515, Oncology Internal Medicine, , Kindai University Hospital, ; 377-2 Ohnohigashi Sayama-shi Osaka, Osaka, 589-8511 Japan

[15 ]GRID grid.470097.d, ISNI 0000 0004 0618 7953, Breast Surgery, , Hiroshima University Hospital, ; 1-2-3 Kasumi Minami-ku Hiroshima-shi, Hiroshima, 734-8551 Japan

[16 ]GRID grid.497282.2, Department of Breast Surgery, , National Cancer Center Hospital East, ; 6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577 Japan

[17 ]GRID grid.418765.9, ISNI 0000 0004 1756 5390, Eisai Co., Ltd., ; 4-6-10 Koishikawa Bunkyo-ku, Tokyo, 112-8088 Japan

[18 ]GRID grid.258799.8, ISNI 0000 0004 0372 2033, Department of Biomedical Statistics and Bioinformatics, , Graduate School of Medicine Kyoto University, ; 54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, 606-8507 Japan

[19 ]GRID grid.486756.e, ISNI 0000 0004 0443 165X, Breast Oncology Center, , The Cancer Institute Hospital of JFCR, ; 3-8-31 Ariake Koto-ku, Tokyo, 135-8550 Japan

Article

Publisher ID: 4408

DOI: 10.1186/s13063-020-04408-w

PMC ID: 7278203

PubMed ID: 32513251

SO-VID: 86833fcb-7ca9-442d-ad7c-0ec07c1619d7

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Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

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