UMIN ID: C000000011
Registered date:22/06/2005
Study of cyclophosphamide, epirubicin and fluoraouracil followed by docetaxel (CEF-DOC) as preoperative chemotherapy in primary operable breast cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Primary breast cancer |
| Date of first enrollment | 2002/06/01 |
| Target sample size | 200 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Primary systemic chemotherapy (cyclophosphamide 500 mg/m2, epirubicin 100 mg/m2 and fluorouracil 500 mg/m2, q3w x 4 cycles, followed by docetaxel 75 mg/m2, q3w x 4 cycles |
Outcome(s)
| Primary Outcome | Clinicl response, pathologic response, safety |
|---|---|
| Secondary Outcome | Breast-conserving rate, overall survival, disease free survival |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 65years-old |
| Gender | Female |
| Include criteria | |
| Exclude criteria | Hypersensitivity for drug Serious coexisting illness Active double cancer Bilateral breast cancer Male breast cancer Pregnant or postpartum women |
Related Information
| Primary Sponsor | Japan Breast Cancer Research Group (JBCRG) |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Osaka Cancer Research Foundation, Advanced Clinical Research Organization |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Katsumasa Kuroi |
| Address | 9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan Japan 103-0016 |
| Telephone | 03-6264-8873 |
| office@jbcrg.jp | |
| Affiliation | JBCRG Head Office |
| scientific contact | |
| Name | 1)Masakazu 2)Yuichi 1)Toi 2)Takatsuka |
| Address | 54 Kawara-cho Shogoin Sakyo-ku, Kyoto, 606-8507 Japan Japan |
| Telephone | 075-751-3660 |
| toi@kuhp.kyoto-u.ac.jp | |
| Affiliation | 1)Graduate School of Medicine Kyoto University 2)Kansai Rosai Hospital 1)Department of Surgery (Breast Surgery) 2)Department of Breast Surgery |