National Cancer Institute
U.S. National Institutes of Health | www.cancer.gov

NCI Home
Cancer Topics
Clinical Trials
Cancer Statistics
Research & Funding
News
About NCI
Clinical Trials (PDQ®)
Patient Version   Health Professional Version
Page Options
Print This Page
E-Mail This Document
Quick Links
Director's Corner

Dictionary of Cancer Terms

NCI Drug Dictionary

Funding Opportunities

NCI Publications

Advisory Boards and Groups

Science Serving People

Español
NCI Highlights
Virtual and Standard Colonoscopy Both Accurate

Denosumab May Help Prevent Bone Loss

Past Highlights
Amgen Protocol No. 20060362 - A Study of AMG 479 With Exemestane or Fulvestrant in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase II


Treatment


Active


18 and over


Pharmaceutical / Industry


20060362
NCT00626106

Trial Description

Summary

This is a randomized, double-blind, placebo-controlled, phase 2 study. Subjects will include postmenopausal women with confirmed HR-positive, locally advanced or metastatic breast cancer, who have disease progression during or within 12 months after completing prior adjuvant endocrine therapy or during the first prior endocrine therapy for metastatic disease.

Eligibility Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed carcinoma of the breast with locally advanced or metastatic disease
  • Confirmation of hormone receptor (HR) positive disease status
  • Amenable to receive endocrine therapy
  • Disease progression while receiving prior endocrine therapy for locally advanced or metastatic breast cancer
  • Postmenopausal woman ≥ 18 years old

Exclusion Criteria:

  • HR-unknown or HR-negative disease
  • Not amenable to endocrine therapy
  • Central nervous system metastasis

Trial Contact Information

Trial Lead Organizations/Sponsors

Amgen, Incorporated

MDStudy Director

Amgen Call CenterPh: 866-572-6436

Trial Sites

U.S.A.
Arizona
  Chandler
 Research Site
California
  Anaheim
 Research Site
  Beverly Hills
 Research Site
  Montebello
 Research Site
  Pleasant Hill
 Research Site
Connecticut
  Stanford
 Research Site
Florida
  Boca Raton
 Research Site
  Boynton Beach
 Research Site
  Coral Springs
 Research Site
  Gainesville
 Research Site
  Lake Worth
 Research Site
Georgia
  Atlanta
 Research Site
Illinois
  Chicago
 Research Site
New Hampshire
  Lebanon
 Research Site
New Jersey
  Mountain Lakes
 Research Site
North Carolina
  High Point
 Research Site
Pennsylvania
  Hershey
 Research Site
Tennessee
  Memphis
 Research Site
Utah
  American Fork
 Research Site
Washington
  Tacoma
 Research Site
Australia
  Footscray
 Research Site
  Geelong
 Research Site
  Melbourne
 Research Site
New South Wales
  Waratah
 Research Site
South Australia
  Woodville
 Research Site
Canada
British Columbia
  Vancouver
 Research Site
Ontario
  Ottawa
 Research Site
  Toronto
 Research Site
France
  Le Mans
 Research Site
  Montpellier cedex 5
 Research Site
  Paris
 Research Site
  St Herblain
 Research Site
Ireland
  Dublin
 Research Site
Spain
  Barcelona
 Research Site
  L'Hospitalet de Llobregat (Barcelona)
 Research Site
  Madrid
 Research Site
  Sabadell
 Research Site
Switzerland
  Chur
 Research Site
  Luzern 16
 Research Site
  Zurich
 Research Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00626106
Information obtained from ClinicalTrials.gov on October 03, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

Back to Top

A Service of the National Cancer Institute
Department of Health and Human Services National Institutes of Health USA.gov