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) studied | Breast cancer |
| Date of first enrollment | 2006/06/01 |
| Target sample size | 60 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| 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. |
Outcome(s)
| Primary Outcome | Feasibility and response rate |
|---|---|
| Secondary Outcome | Progression free survival, overall survival and adverse events are assessed |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Female |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | Kyushu Breast Cancer Study Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Non-profit Organization Clinical Hematology/Oncology Study Group |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Kazuo Tamura |
| Address | Japan |
| Telephone | |
| Affiliation | Kyushu Breast Cancer Study Group Executive office |
| scientific contact | |
| Name | Shoshu Mitsuyama |
| Address | 1-1, 2-chome, Bashaku, Kokurakita-ku, Kitakyushu Japan |
| Telephone | |
| Affiliation | Kitakyushu Municipal Medical Center Surgery |