NIPH Clinical Trials Search

UMIN ID: C000000447

Registered date:13/07/2006

A Phase I/II Study of Vinorelbine plus Trastuzumab in Patients with Advanced/Recurrent Breast Cancer Previously Treated with Anthracyclines and Taxanes

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedBreast cancer
Date of first enrollment2006/06/01
Target sample size60
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Vinorelbine 25 mg/m2 day 1, 8 Trastuzumab at 4 mg/kg for the first dosing and 2 mg/kg days 1, 8 ,15 Continue this regimen every 3 wks after safty profiles and tumor response are acceptable.


Primary OutcomeFeasibility and response rate
Secondary OutcomeProgression free survival, overall survival and adverse events are assessed

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
Include criteria
Exclude criteria1.Significant interstitial pneumonia or pulmonary fibrosis by X-ray or CT scan 2.Acute myocardial infarction within 12 months before enrollment 3.Serious cardiac disease which is not controllable by drugs 4.Drug allergy 5.Uncontrolled diabetes or hypertension 6.Persistent use of systemic steroids 7.Uncontrolled medical complications 8.Metastasis to the central nervous system 9.Woman who are apparently or possibly pregnant or have desire to be come pregnant 10.Double cancer 11.Infection or possible infection associated with clinical symptoms such as fever

Related Information


public contact
Name Kazuo Tamura
Address Japan
Affiliation Kyushu Breast Cancer Study Group Executive office
scientific contact
Name Shoshu Mitsuyama
Address 1-1, 2-chome, Bashaku, Kokurakita-ku, Kitakyushu Japan
Affiliation Kitakyushu Municipal Medical Center Surgery