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) studied | breast cancer |
| Date of first enrollment | 2003/02/01 |
| Target sample size | 35 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | chemotherapy(Trastuzumab) |
Outcome(s)
| Primary Outcome | response rate |
|---|---|
| Secondary Outcome | Progression-free survival(PFS) Overall survival(OS) adverse event(AE) |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Female |
| Include criteria | |
| Exclude criteria | Documented 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
| Primary Sponsor | H/D study group on Breast Cancer |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | H/D study group on Breast Cancer |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | 1-14, 2-chome Hoenzaka, chuou-ku, Osaka-city, Osaka Japan |
| Telephone | 06-6942-1331 |
| 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 |
| Affiliation | Osaka National Hospital Department of Surgery(Breast Oncology) |