UMIN ID: UMIN000000504
Registered date:30/10/2006
The safety and efficacy trial of sequential administration with AP (Doxorubicin/Paclitaxel) followed by weekly Paclitaxel as preoperative chemotherapy for breast cancer: SBCCSG-07
Basic Information
| Recruitment status | Complete: follow-up continuing |
|---|---|
| Health condition(s) or Problem(s) studied | Primary breast cancer |
| Date of first enrollment | 2005/11/28 |
| Target sample size | 30 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Doxorubicin 50mg/m2, Paclitaxel 150mg/m2, q3Wx4cycles followed by paclitaxel 80mg/m2, q1Wx12cycles |
Outcome(s)
| Primary Outcome | Pathological complete response rate Clinical complete response rate |
|---|---|
| Secondary Outcome | Disease-free survival Overall survival Toxicity Breast conserving rate The rate of completion |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 70years-old |
| Gender | Female |
| Include criteria | |
| Exclude criteria | 1. severe complication 2. suspicious of infection 3. past history of allergic reaction to cremophor EL (polyoxyethylated caster oil) or polysorbate 4. Pregnant or lactating women 5. Doctor's decision for exclusion |
Related Information
| Primary Sponsor | Saitama Breast Cancer Clinical Study Group (SBCCSG) |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Toshihiro Kai |
| Address | 4-261-1 Kishiki-cho, Omiya-ku, Saitama City, Saitama 330-0843 Japan |
| Telephone | 048-600-1722 |
| toshikai@sbccsg.org | |
| Affiliation | Saitama Breast Cancer Clinical Study Group (SBCCSG) Executive office |
| scientific contact | |
| Name | Toshio Tabei |
| Address | 818 Komuro Ina-machi Kitaadachi-gun, Saitama 362-0806 Japan |
| Telephone | 048-722-1111 |
| Affiliation | Saitama Cancer Center Endocrinology |