MedTrace Logo

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

NCT01262274 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2015-05-21

No results posted yet for this study

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.

Conditions

  • Breast Neoplasms

Interventions

DRUG

Anastrozole

ANA is given 1mg daily for 24 weeks.

DRUG

Anastrozole plus tegafur-uracil

ANA is given 1mg daily for 24 weeks. UFT is given by 270mg/m2 twice a day for 24 weeks.

Sponsors & Collaborators

  • Department of breast and endocrine surgery graduate school of Medicine Osaka University

    collaborator UNKNOWN

  • Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

    lead OTHER

Principal Investigators

  • Shinzaburo Noguchi, M.D., Ph.D. · Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-06-30
Completion
2014-04-30

Countries

  • Japan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01262274 on ClinicalTrials.gov