NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000263

Registered date:15/10/2005

First-line Trastuzumab monotherapy in patients with HER2-positive metastatic breast cancer(MBC)- a phase 2 study

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedbreast cancer
Date of first enrollment2003/02/01
Target sample size35
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)chemotherapy(Trastuzumab)

Outcome(s)

Primary Outcomeresponse rate
Secondary OutcomeProgression-free survival(PFS) Overall survival(OS) adverse event(AE)

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderFemale
Include criteria
Exclude criteriaDocumented history of serious hypersensitivity reaction on the medical drugs Severe complication Fever, suspicious of infection Severe pleural fluid and pericardial effusion Symptomatic brain metastasis Active double cancer Interstitial pneumonia or pulmonary fibrosis Neuropathy Grade 2,3 or 4 edema Pregnant or lactating women Doctor' s decision for exclusion

Related Information

Contact

public contact
Name
Address 1-14, 2-chome Hoenzaka, chuou-ku, Osaka-city, Osaka Japan
Telephone 06-6942-1331
E-mail
Affiliation H/D study group on Breast Cancer Executive Office
scientific contact
Name Norikazu Masuda
Address 1-14, 2-chome Hoenzaka, chuou-ku, Osaka-city, Osaka Japan
Telephone 06-6942-1331
E-mail
Affiliation Osaka National Hospital Department of Surgery(Breast Oncology)