UMIN ID: C000000260
Registered date:10/10/2005
Evaluation of effectiveness and safety of Capecitabine monotherapy in patients with Anthracycline-pretreated Metastatic Breast Cancer:A multicenter phase2 study
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | Metastatic Breast Cancer |
Date of first enrollment | 2004/11/01 |
Target sample size | 70 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Chemotherapy (Capecitabine 1657mg/m2 day1-21,q4w) |
Outcome(s)
Primary Outcome | Response rete |
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Secondary Outcome | Clinical benefit rete, Progression-free survival, Overall survival, Safety profiles |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | 75years-old |
Gender | Female |
Include criteria | |
Exclude criteria | 1) have capecitabine before 2) Hypersensitivity to drugs 3) severe complication 4) active double cancer 5) in pregnancy or lactation |
Related Information
Primary Sponsor | KBCSG (Kinki Breast Cancer Study Group) |
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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 Surgery (Breast Oncology) |