UMIN ID: UMIN000000869
Registered date:30/10/2007
A Phase II Study of Capecitabine plus Paclitaxel Combination Chemotherapy in Patients with Metastatic Breast Cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Metastatic Breast Cancer |
| Date of first enrollment | 2006/05/01 |
| Target sample size | 42 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Chemotherapy (Capecitabine 1657mg/m2, day1-21, q4w, Paclitaxel 80mg/m2, day1,8,15, q4w) |
Outcome(s)
| Primary Outcome | Response rete |
|---|---|
| Secondary Outcome | Time to treatment failure, Progression-free survival, Overall survival, Safety profiles |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Female |
| Include criteria | |
| Exclude criteria | 1) Have Capecitabine before 2) Have Paclitaxel for metastatic lesion before 3) Hypersensitivity to drugs 4) active double cancer 5) severe complication 6) in pregnancy or lactation 7) Symptomatic brain metastasis |
Related Information
| Primary Sponsor | KBCSG (Kinki Breast Cancer Study Group) |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Non profit organization Epidemiological and Clinical Reserch Information Network |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Shinzaburo Noguchi |
| Address | 2-2, yamadaoka, suita-city, Oosaka Japan |
| Telephone | 06-6879-3772 |
| Affiliation | KBCSG (Kinki Breast Cancer Study Group) Executive Office |
| scientific contact | |
| Name | Norikazu Masuda |
| Address | 2-1-14, Hoenzaka, chuou-ku, Osaka-city, Osaka Japan |
| Telephone | 06-6942-1331 |
| Affiliation | OSAKA NATIONAL HOSPITAL Department of Surgery |