| JaLCDOI | 10.18926/AMO/54607 |
|---|---|
| FullText URL | 70_5_425.pdf |
| Author | Tamura, Tomoki| Hirata, Taizo| Tabata, Masahiro| Hinotsu, Shiro| Hamada, Akinobu| Motoki, Takayuki| Iwamoto, Takayuki| Mizoo, Taeko| Nogami, Tomohiro| Shien, Tadahiko| Taira, Naruto| Matsuoka, Junji| Doihara, Hiroyoshi| |
| 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 |
| Publication Title | Acta Medica Okayama |
| Published Date | 2016-10 |
| 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 | English |
| Copyright Holders | CopyrightⒸ 2016 by Okayama University Medical School |
| File Version | publisher |
| Refereed | True |
| PubMed ID | 27777441 |
| Web of Science KeyUT | 000388098700018 |
| Author | Mizoo, Taeko| Taira, Naruto| Nishiyama, Keiko| Nogami, Tomohiro| Iwamoto, Takayuki| Motoki, Takayuki| Shien, Tadahiko| Matsuoka, Junji| Doihara, Hiroyoshi| Ishihara, Setsuko| Kawai, Hiroshi| Kawasaki, Kensuke| Ishibe, Youichi| Ogasawara, Yutaka| Komoike, Yoshifumi| Miyoshi, Shinichiro| |
|---|---|
| Published Date | 2013-12-01 |
| Publication Title | BMC Cancer |
| Volume | volume13 |
| Content Type | Journal Article |
