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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
Hinotsu, Shiro Center for Innovative Clinical Medicine, Okayama University Hospital
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
Iwamoto, Takayuki Department of Breast and Endocrinological Surgery, Okayama University Hospital
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
Taira, Naruto Department of Breast and Endocrinological Surgery, Okayama University Hospital
Matsuoka, Junji Department of Breast and Endocrinological Surgery, Okayama University Hospital
Doihara, Hiroyoshi Department of Breast and Endocrinological Surgery, Okayama University Hospital
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.
Keywords
breast cancer
phase I trial
docetaxel
Amo Type
Clinical Study Protocols
Published Date
2016-10
Publication Title
Acta Medica Okayama
Volume
volume70
Issue
issue5
Publisher
Okayama University Medical School
Start Page
425
End Page
427
ISSN
0386-300X
NCID
AA00508441
Content Type
Journal Article
language
英語
Copyright Holders
CopyrightⒸ 2016 by Okayama University Medical School
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publisher
Refereed
True
PubMed ID
Web of Sience KeyUT