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Anastrozole or Fulvestrant in Treating Postmenopausal Patients With Breast Cancer

NCT00871858 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-02-24

Study results available
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Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by lowering the amount of estrogen the body makes. Fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. Given the lack of clinical data on fulvestrant in patients with large operable or locally advanced hormone-receptor-positive breast cancer, and the potential to identify differences in the mechanism of resistance using the neoadjuvant model,we decided to perform a multicentre randomised phase II clinical trial of anastrozole and fulvestrant.

PURPOSE: The aim of this study was to assess the efficacy of neoadjuvant anastrozole and fulvestrant treatment of large operable or locally advanced hormone-receptor-positive breast cancer not eligible for initial breast-conserving surgery, and to identify genomic changes occurring after treatment.

Conditions

Interventions

DRUG

anastrozole

Given orally

DRUG

fulvestrant

Given intramuscularly

Sponsors & Collaborators

  • National Cancer Institute, France

    collaborator OTHER_GOV

  • Institut Bergonié

    lead OTHER

Principal Investigators

  • Louis Mauriac, MD · Institut Bergonié

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-03-18
Primary Completion
2013-11-30
Completion
2018-07-02

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

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 NCT00871858 on ClinicalTrials.gov