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Fulvestrant (Faslodex) + Anastrozole (Arimidex) vs Anastrozole

NCT00543127 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 870

Last updated 2023-03-10

Study results available
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Summary

Postmenopausal women with hormone receptor positive and negative Her2 tumours.

Before randomization, the patients will be stratified according to the center, positive nodes (0 vs. 1-3 vs. ≥4), previous chemotherapy (yes vs no) and hormonal receptors status.

Conditions

Interventions

DRUG

Fulvestrant

500 mg Im Fulvestrant day 0, 250 mg days 14 and 28(charge dose); later 250 mg each 28 days during 3 years plus 1 mg oral Anastrozole per day during 5 years.

DRUG

Anastrozole

1 mg oral Anastrozole per day during 5 years.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Spanish Breast Cancer Research Group

    lead OTHER

Principal Investigators

  • Study Director · Hospital General Universitario Gregorio Marañón

  • Study Director · Centro Oncológico de Galicia

  • Study Director · Hospitales Universitarios Virgen del Rocío

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Spain

Study Locations

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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 NCT00543127 on ClinicalTrials.gov