title: A Phase I Trial of 100 mg/m2 Docetaxel in Patients with Advanced or Recurrent Breast Cancer.
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.
authors: Department of Allergy and Respiratory Medicine, Okayama University Hospital, Okayama 700-8558, Japan.
authors: Tomoki
authors: T
authors: Tamura
authors: Taizo
authors: T
authors: Hirata
authors: Masahiro
authors: M
authors: Tabata
authors: Shiro
authors: S
authors: Hinotsu
authors: Akinobu
authors: A
authors: Hamada
authors: Takayuki
authors: T
authors: Motoki
authors: Takayuki
authors: T
authors: Iwamoto
authors: Taeko
authors: T
authors: Mizoo
authors: Tomohiro
authors: T
authors: Nogami
authors: Tadahiko
authors: T
authors: Shien
authors: Naruto
authors: N
authors: Taira
authors: Junji
authors: J
authors: Matsuoka
authors: Hiroyoshi
authors: H
authors: Doihara
mesh_terms: D000328:Adult; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D002985:Clinical Protocols; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D043823:Taxoids / Q000008:administration & dosage / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel