drugset / Trial / NCT01262274
Randomized Phase II Trial of Anastrozole Plus Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Breast Cancer
Phase 2
Terminated
57 enrolled
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Department of breast and endocrine surgery graduate school of Medicine Osaka University · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The Aim of this study is to validate a treatment of anastrozole in combination with tegafur-uracil as pre-operative therapy for postmenopausal primary breast cancer. Although pre-operative hormone therapy is a novel therapeutic approach, only hormone therapy has limitation in terms of efficacy. Metronomic chemotherapy, which is the frequent administration of low-dose cytotoxic agents, is not only target tumor cells but also inhibiting angiogenesis. Because there was a report that efficacy of hormone therapy add to metronomic chemotherapy as pre-operative therapy, a randomized phase II trial of anastrozole (ANA) in combination with/without metronomic tegafur-uracil (UFT) as neo-adjuvant for postmenopausal breast cancer will be conducted.
Timeline
- Start
- 2010-12
- Primary completion
- 2013-06
- Completion
- 2014-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Anastrozole | Other / unclassified | 1 mg | — |
| Subject | tegafur-uracil | Small molecule | 270 mg/m2 | — |