ID | 54607 |
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Author |
Tamura, Tomoki
Department of Allergy and Respiratory Medicine, Okayama University Hospital
Hirata, Taizo
Department of Medical Oncology, National Hospital Organization Kure Medical Center
Tabata, Masahiro
Department of Allergy and Respiratory Medicine, Okayama University Hospital
Kaken ID
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Hinotsu, Shiro
Center for Innovative Clinical Medicine, Okayama University Hospital
Kaken ID
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Hamada, Akinobu
Division of Clinical Pharmacology & Translational Research, Exploratory Oncology Research & Clinical Trial Center, National Cancer Center
Motoki, Takayuki
Department of Breast and Endocrinological Surgery, Okayama University Hospital
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Iwamoto, Takayuki
Department of Breast and Endocrinological Surgery, Okayama University Hospital
Kaken ID
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Mizoo, Taeko
Department of Breast and Endocrinological Surgery, Okayama University Hospital
Nogami, Tomohiro
Department of Breast and Endocrinological Surgery, Okayama University Hospital
Shien, Tadahiko
Department of Breast and Endocrinological Surgery, Okayama University Hospital
ORCID
Kaken ID
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Taira, Naruto
Department of Breast and Endocrinological Surgery, Okayama University Hospital
Kaken ID
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Matsuoka, Junji
Department of Breast and Endocrinological Surgery, Okayama University Hospital
Kaken ID
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Doihara, Hiroyoshi
Department of Breast and Endocrinological Surgery, Okayama University Hospital
Kaken ID
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Abstract | Docetaxel is a standard treatment for patients with advanced or recurrent breast cancer. The recommended dose is 60 to 100 mg/m2. Previous study have shown that the tumor response rates of patients who received docetaxel monotherapy at doses of 60, 75, and 100 mg/m2 were 22.1% , 23.3% , and 36.0% , respectively, and there was a significant relationship between the dose and response. In Europe and the United States, docetaxel is approved at a dose of 100 mg/m2, and Japanese guidelines also recommend a dose of 100 mg/m2. However, the approved dose in Japan is up to 75 mg/m2. We have launched a phase I trial evaluating 100 mg/m2 docetaxel in patients with advanced or relapsed breast cancer. The major eligibility criteria are as follows: age ≥20 years, pathologically diagnosed breast cancer, recurrent or advanced breast cancer, a good performance status, and HER2 [human epidermal growth factor receptor 2] negative. The primary endpoint is demonstrated safety of 100 mg/m2 docetaxel. This study will clarify whether 100mg/m2 docetaxel can be administrated safely in Japanese patients with advanced or recurrent breast cancer.
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Keywords | breast cancer
phase I trial
docetaxel
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Amo Type | Clinical Study Protocols
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Publication Title |
Acta Medica Okayama
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Published Date | 2016-10
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Volume | volume70
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Issue | issue5
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Publisher | Okayama University Medical School
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Start Page | 425
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End Page | 427
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ISSN | 0386-300X
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NCID | AA00508441
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Content Type |
Journal Article
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language |
English
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Copyright Holders | CopyrightⒸ 2016 by Okayama University Medical School
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File Version | publisher
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Refereed |
True
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PubMed ID | |
Web of Science KeyUT |