drugset / Trial / NCT01262274

Randomized Phase II Trial of Anastrozole Plus Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Breast Cancer

NCT01262274

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

EvaluationDrugModalityDoseRoute
Comparator Anastrozole Other / unclassified 1 mg
Subject tegafur-uracil Small molecule 270 mg/m2

Indications