Breast cancer
Conditions
Interventions
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.
Sponsors
Kyushu Breast Cancer Study Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Advanced/recurrent breast cancer previously treated with anthracyclines and taxanes 2.Her2 positive 3.Mesasuarable or evaluable lesions suitable to RECIST 4.Advanced/recurrent breast cancer who were previously treated with taxanes and no other chemotherapeutic agents (oral fluorinated pyrimidines including capecitabine and TS-1) 5.Expected survival time: more than 3 months 6.Women aged 20 to 75 years at the time of enrollment 7.Performance Status 0-2 8.Adequate functions of major organs 9.Written informed consent
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility and response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, overall survival and adverse events are assessed | — |
Countries
Japan
Contacts
Public ContactKazuo Tamura
Kyushu Breast Cancer Study Group Executive office
Outcome results
None listed