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S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer

NCT00075764 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 695

Last updated 2021-01-13

Study results available
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Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using drugs such as anastrozole and fulvestrant may fight breast cancer by blocking the use of estrogen. It is not yet known whether anastrozole is more effective with or without fulvestrant in treating breast cancer.

PURPOSE: This randomized phase III trial is studying giving anastrozole together with fulvestrant to see how well it works compared to anastrozole alone as first-line therapy in treating postmenopausal women with metastatic breast cancer.

Conditions

Interventions

DRUG

anastrozole

Given orally

DRUG

fulvestrant

Given intramuscularly

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • NCIC Clinical Trials Group

    collaborator NETWORK

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Rita S. Mehta, MD · Chao Family Comprehensive Cancer Center

  • Theodore A. Vandenberg, MD · London Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2012-12-31
Completion
2018-10-01

Countries

  • United States
  • Canada

Study Locations

More Related Trials

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 NCT00075764 on ClinicalTrials.gov