A Phase I/II Study of Vinorelbine plus Trastuzumab in Patients with Advanced/Recurrent Breast Cancer Previously Treated with Anthracyclines and Taxanes
Phase 1
- Conditions
- Breast cancer
- Registration Number
- JPRN-C000000447
- Lead Sponsor
- Kyushu Breast Cancer Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
1.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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method