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Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy

NCT00256698 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 514

Last updated 2012-08-01

Study results available
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Summary

The purpose of this study is to determine the efficacy of anastrozole monotherapy versus maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared with in treatment of hormone receptor positive women with first relapse of breast cancer.

Conditions

Interventions

DRUG

Fulvestrant

intramuscular injection 250 mg loading dose (LD) regimen

DRUG

Anastrozole

1 mg oral tablet

Sponsors & Collaborators

Principal Investigators

  • Roger Henriksson, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2009-04-30
Completion
2012-02-29

Countries

  • Canada
  • Costa Rica
  • Finland
  • France
  • Germany
  • Guatemala
  • Iceland
  • Italy
  • Norway
  • Portugal
  • Sweden
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT00256698 on ClinicalTrials.gov