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A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer.

NCT01602380 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 462

Last updated 2026-02-27

Study results available
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Summary

The purpose of the study is to compare how treatment with Fulvestrant (FASLODEX) or Anastrozole (ARIMIDEX) effects disease progression for women with locally advanced or metastatic breast cancer who have not had prior hormonal treatment.

Conditions

  • Hormone Receptor Positive Breast Cancer

Interventions

DRUG

faslodex 500mg

2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter

DRUG

arimidex 1mg

oral tablet 1 daily

DRUG

faslodex dummy

2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter

DRUG

arimidex dummy

oral tablet 1 daily

Sponsors & Collaborators

Principal Investigators

  • Shankar S, MD · AstraZeneca

  • John Robertson, MD · Graduate Medicine and Health School, University of Nottingham, UK

  • Matthew Ellis, DM · Washington University School of Medicine, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-17
Primary Completion
2016-04-11
Completion
2026-01-16

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • China
  • Czechia
  • Italy
  • Japan
  • Mexico
  • Peru
  • Poland
  • Romania
  • Russia
  • Slovakia
  • South Africa
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT01602380 on ClinicalTrials.gov