UMIN ID: C000000056
Registered date:12/08/2005
Phase III Randomized Adjuvant Study of Tamoxifen Alone Versus Sequential Tamoxifen and Anastrozole in Hormone-Responsive Postmenopausal Breast Cancer Patients
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Hormone-responsive postmenopausal primary breast cancer |
| Date of first enrollment | 2002/11/01 |
| Target sample size | 2500 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | TAM:Tamoxifen alone (total 5 years) ANA:Sequential Tamoxifen and Anastrozole (change after registration, total 5 years) |
Outcome(s)
| Primary Outcome | Disease-Free Survival Adverse Events |
|---|---|
| Secondary Outcome | Relapse-Free Survival Overall Survival Health-Related QOL Efficacy of medical economy |
Key inclusion & exclusion criteria
| Age minimum | 65years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Female |
| Include criteria | |
| Exclude criteria | (1)Invasive carcinoma of other organs (less than 5years after the last treatment) (2)Metachronous or synchronous bilateral breast cancer (3)Past deep venous embolism (4)Osteoporosis needed to be treated or past bone fracture because of osteoporosis (5)Patients judged inappropriate for this study by the physicians |
Related Information
| Primary Sponsor | N-SAS BC 03 executive committee |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Public Health Research Foundation |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Akira Yamao |
| Address | 1-1-7, Nishiwaseda, Shinjyuku-ku, Tokyo, 169-0051 JAPAN Japan |
| Telephone | 03-5287-2633 |
| support@csp.or.jp | |
| Affiliation | Public Health Research Foundation Comprehensive Support Project for Clinical Research |
| scientific contact | |
| Name | Tomohiko Aihara |
| Address | 3-3-20, Makiochi, Minoo-shi, Osaka, 562-0004, Japan Japan |
| Telephone | 072-723-9001 |
| no@mail | |
| Affiliation | Aihara Hospital Department of Breast |