NIPH Clinical Trials Search

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) studiedMetastatic Breast Cancer
Date of first enrollment2006/05/01
Target sample size42
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Chemotherapy (Capecitabine 1657mg/m2, day1-21, q4w, Paclitaxel 80mg/m2, day1,8,15, q4w)


Primary OutcomeResponse rete
Secondary OutcomeTime to treatment failure, Progression-free survival, Overall survival, Safety profiles

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
Include criteria
Exclude criteria1) 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


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