UMIN ID: UMIN000001736
Registered date:27/02/2009
Neo-adjuvant therapy with paclitaxel followed by FEC fluoraouracil, epirubicin and cyclophosphamide) for primary breast cancer(KBC-SG0801)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Primary breast cancer |
| Date of first enrollment | 2008/09/01 |
| Target sample size | 32 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Paclitaxel 80mg/m2 every week for 12 cycles. 5-FU 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2 on day 1, every 3 weeks for 4 cycles. Operation is to be offered to the patients with breast cancer as a curative intent within 2 months after neoadjuvant chemotherapy. |
Outcome(s)
| Primary Outcome | Pathological complete response rate |
|---|---|
| Secondary Outcome | Safety Clinical efficacy Overall survival Disease free survival Breast-conserving rate |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Female |
| Include criteria | |
| Exclude criteria | 1. Severe medical conditions 2. Suspected infectious disease 3. Alergy to clemohol EL 4. Severe peripheral neuropathy 5. Pregnant or lactating women |
Related Information
| Primary Sponsor | Kyushu Breast Cancer Study Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Non-profit Organization Clinical Hematology/Oncology Study Group |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Kazuo Tamura |
| Address | 1-8-17-204, Watanabe-dori, Chuo-ku, Fukuoka Japan |
| Telephone | 092-406-4166 |
| npo@chotsg.com | |
| Affiliation | Kyushu Breast Cancer Study Group Executive office |
| scientific contact | |
| Name | Maki Tanaka |
| Address | 21 Kushihara-Cho, Kurume Japan |
| Telephone | 0942-33-1211 |
| maki@tanaka.name | |
| Affiliation | Kurume Daiichi Social Insurance Hospital Surgery |