UMIN ID: UMIN000001481
Registered date:05/11/2008
Open labelled multicenter randomized comparative trial of high-dose toremifene for non-steroidal aromatase inhibitor resistant breast cancer compared to exemestane
Basic Information
| Recruitment status | Complete: follow-up continuing |
|---|---|
| Health condition(s) or Problem(s) studied | Advanced/recurrent breast cancer |
| Date of first enrollment | 2008/11/01 |
| Target sample size | 90 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | TOR: Toremifene (120mg) is orally administered once a day everyday. EXE: Exemestane (25mg) is orally administered once a day everyday. |
Outcome(s)
| Primary Outcome | clinical benefit rate |
|---|---|
| Secondary Outcome | response rate, time to progression, time to treatment failure, adverse events, presictive factor |
Key inclusion & exclusion criteria
| Age minimum | 30years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Female |
| Include criteria | |
| Exclude criteria | 1. The case with active other malignancies 2. The case with past history of drug allergy or hypersensitivity 3. The case during pregnancy or lactation 4. The case with severe progressive situation with non-indication for the hormone therapy 5. The case judged inappropriate by physicians |
Related Information
| Primary Sponsor | Department of Breast and Endocrine Surgery Graduate School of Medical Sciences, Kumamoto University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Department of Breast and Endocrine Surgery Graduate School of Medical Sciences, Kumamoto University |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Ayako Okabe |
| Address | 1-1-1 Honjo, Kumamoto Japan |
| Telephone | 096-373-5521 |
| bsokabe@kumamoto-u.ac.jp | |
| Affiliation | Graduate School of Medical Sciences Department of Breast and Endocrine Surgery |
| scientific contact | |
| Name | Hirotaka Iwase |
| Address | 1-1-1 Honjo, Chuo-ku Kumamoto Japan |
| Telephone | 096-373-5521 |
| hiwase@kumamoto-u.ac.jp | |
| Affiliation | Graduate School of Medical Sciences, Kumamoto University Department of Breast and Endocrine Surgery |