UMIN ID: UMIN000000802
Registered date:18/08/2007
Assessment of the Efficacy of Preoperative Exemestane Therapy for Endocrine-sensitive Postmenopausal Breast Cancer (SBCCSG-10)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Postmenopausal breast cancer |
| Date of first enrollment | 2007/08/01 |
| Target sample size | 23 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Exemestane (25 mg Tablet) is internally administered once a day everyday. |
Outcome(s)
| Primary Outcome | Time To Progression |
|---|---|
| Secondary Outcome | 1.Maximum efficacy period 2.Rate of tumor reduction 3.Relationship between pathological response rate and capacity of cell proliferation, activity of aromatase and functional analysis of estrogen receptor of breast cancer cells 4.Time To Treatment Failure 5.Adverse events 6.Changes in bone mineral density |
Key inclusion & exclusion criteria
| Age minimum | 60years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Female |
| Include criteria | |
| Exclude criteria | 1.Patients under chemotherapy and hormone therapy (for tumors) 2.Patients under treatment with the drugs (including HRT) that may influence on the conditions of sex hormone 3.Patients with a past history of breast cancer or with double cancer |
Related Information
| Primary Sponsor | Saitama Breast Cancer Clinical Study Group (SBCCSG) |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | none |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Toshihiro Kai |
| Address | 3F, Capital Bldg. 4-261-1, Kishiki-cho, Omiya-ku, Saitama-City 330-0843, Saitama Prefecture Japan |
| Telephone | 048-600-1722 |
| toshikai@nyc.odn.ne.jp | |
| Affiliation | Saitama Breast Cancer Clinical Study Group (SBCCSG) Executive office(c/o: Shin-toshin Ladies' Clinic) |
| scientific contact | |
| Name | Toshio Tabei |
| Address | 818 Komuro Ina Kitaadachi, Saitama 362-0806 Japan |
| Telephone | 048-722-1111 |
| Affiliation | Saitama Cancer Center Breast and Medical Oncology |