UMIN ID: UMIN000000513
Registered date:06/11/2006
Prospecitve study of radiotherapy without surgery after AC followed by weekly paclitaxel and trastuzumab for inflammatory breast cancer with HER2 over expression
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Inflammatory breast cancer |
| Date of first enrollment | 2006/11/01 |
| Target sample size | 20 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | The chemotherapy of AC consisted of 60mg/m2 of doxorubicin and 600mg/m2 of cyclophosphamide every 21 days four cycles. Paclitaxel dose of 80 mg/m2 was given weekly for 12 weeks and trastuzumab for 52 weeks. Whole-breast radiotherapy with an optional boost was initiated after the completion of chemotherapy whose total dose was 5000 to 6000cGy in 25 to 30 fractions.20 |
Outcome(s)
| Primary Outcome | TTP (Time To Progression) |
|---|---|
| Secondary Outcome | Overall survival Toxicity Clinical response rate Pathological response rate |
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 castor 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 | 1550 Katayanagi, Minuma-ku, Saitama-shi, Saitama 337-0024 Japan |
| Telephone | 048-686-7155 |
| 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 |