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Completed Phase 3 Interventional Results available

Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole

ClinicalTrials.gov ID: NCT00863655

Public ClinicalTrials.gov record NCT00863655. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 23, 2026, 10:45 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized Double-Blind, Placebo-Controlled Study of Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole

Study identification

NCT ID
NCT00863655
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
724 participants

Conditions and interventions

Conditions

Interventions

  • Everolimus Drug
  • Exemestane Drug
  • Everolimus Placebo Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 2, 2009
Primary completion
Dec 3, 2014
Completion
Dec 3, 2014
Last update posted
May 1, 2017

2009 – 2014

United States locations

U.S. sites
63
U.S. states
27
U.S. cities
57
Facility City State ZIP Site status
Ironwood Cancer and Research Centers Chandler Arizona 85224
Highlands Oncology Group DeptofHighlandsOncologyGrp(2) Fayetteville Arkansas 72703
Kaiser Permanente Medical Group Kaiser Permanente-Moanalua M.C Anaheim California 92807
Comprehensive Blood and Cancer Center Dept. of CBCC (3) Bakersfield California 93309
Cancer Care Associates Dept.ofCancerCareAssoc. (2) Fresno California 93720
Grass Valley Hematology Oncology Medical Group Dept. of Grass Valley Hem/Onc Grass Valley California 95945
Scripps Clinic SC La Jolla California 92121
The Angeles Clinic and Research Institute Los Angeles California 90025
USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3 Los Angeles California 90053
Sharp Memorial Hospital SharpClinicalOncologyResearch San Diego California 92123
University of California San Francisco UCSF Medical Center San Francisco California 94101
Premiere Oncology/Pinnacle Oncology Hematology Dept.ofPremiereOncologyAZ Santa Monica California 90404
St Joseph Heritage Healthcare Dept. of RRMG (4) Santa Rosa California 94503
Comprehensive Cancer Center - Boca Raton Deerfield Beach Boca Raton Florida 33248
Florida Cancer Research Institute Davie Florida 33328
Florida Cancer Specialists DeptofFloridaCancerSpecialists Fort Myers Florida 33901
Memorial Hospital Memorial Cancer Institute Hollywood Florida 33021
MD Anderson Cancer Center - Orlando Dept.ofMDACC-Orlando(2) Orlando Florida 32806
Palm Beach Cancer Institute West Palm Beach Florida 33401
Florida Medical Clinic PA Dept.ofFloridaMedicalClinic Zephyrhills Florida 33542
Georgia Cancer Specialists. Drug Ship Decatur Georgia 30033
Rush University Medical Center Study Coordinator Chicago Illinois 60612
Oncology Specialists, SC Dept.of Oncology Specialists Park Ridge Illinois 60068-0736
Hematology Oncology of Indiana Indianapolis Indiana 46260
Horizon Oncology Center Lafayette Indiana 47905
Cancer Center of Kansas Dept.ofCancerCtr.ofKansas Wichita Kansas 67214-3728
University of Louisville / James Graham Brown Cancer Center SC Louisville Kentucky 40202
Hematology Oncology Clinic Hematology Oncology Clinic (2) Baton Rouge Louisiana 70808
Crescent City Research Consortium, LLC Dept of Hem&Onc Specialist - 2 Metairie Louisiana 70006
Anne Arundel Health System Research Institute Wayson Pavilion Annapolis Maryland 21401
Mercy Medical Center Medical Oncology & Hematology Baltimore Maryland 21202
Weinberg Cancer Institute at Franklin Square Hospital Baltimore Maryland 21237-3998
Maryland Hematology/Oncology Associates, P.A. Baltimore Maryland 21237
Frederick Memorial Hospital Dept. of FMH-IRB Frederick Maryland 21701
Holy Cross Hospital Holy Cross Silver Spring Maryland 20910
Lahey Clinic Dept of Lahey Clinic (2) Burlington Massachusetts 01805
Fairview Southdale Medical Oncology Clinic Edina Minnesota 55435
St. Louis Cancer & Breast Institute Dept.ofSt.LouisCancer&Breast St Louis Missouri 63141
Southeast Nebraska Oncology Cancer Center Lincoln Nebraska 68510
Regional Cancer Care Associates Dept. of the CCHD Cherry Hill New Jersey 08003
Trinitas Comprehensive Cancer Center Dept. of Trinitas Elizabeth New Jersey 07207
University of New Mexico Cancer Research Center Dept of UNM Cancer & Research Albuquerque New Mexico 87131
Clinical Research Alliance Dept.ofArenaOncologyAssoc(2) Lake Success New York 11042
ProHealth Care Lake Success New York 11042
Beth Israel Medical Center Dept.ofBeth Israel Med. Ctr(2) New York New York 10003
Weill Cornell Medical College Weill Cornell Med. Ctr. New York New York 10021
Hematology Oncology Association of Rockland Nyack New York 10960
Marion L. Shepard Cancer Center Washington North Carolina 27889
Cancer Centers of Southwest Oklahoma Cancer Research Dept.of Southwest Oklahoma Lawton Oklahoma 73505
Cancer Care Associates SC Tulsa Oklahoma 74136
Penn State University / Milton S. Hershey Medical Center Division of Oncology (2) Hershey Pennsylvania 17033-0850
Medical University of South Carolina -Hollings Cancer Center Dept. MUSC/HollingsCancerCtr Charleston South Carolina 29425
Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(5) Nashville Tennessee 37203
University of Texas Southwestern Medical Center SimmonsComprehensiveCancerCtr. Dallas Texas 75390-8852
The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD(2) Fort Worth Texas 76104
University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(2) Houston Texas 77030-4009
Hope Oncology HOPE Richardson Richardson Texas 75080
Northern Utah Cancer Associates SC Ogden Utah 84403-3105
Central Utah Clinic CRAD001Y2301 Provo Utah 84604
Utah Cancer Specialists Dept.of Utah Cancer Spec. (2) Salt Lake City Utah 84106
University of Utah / Huntsman Cancer Institute Dept.ofHuntsmanCancerInst.(2) Salt Lake City Utah 84112
Medical Oncology & Hematology Associates of Northern VA Med. Onc&Hem Assoc. of No.VA Reston Virginia 20190
University of Wisconsin Hospital & Clinics UW ComprehensiveCancerCtr(2) Madison Wisconsin 53792

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 137 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00863655, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 1, 2017 · Synced Jul 23, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00863655 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →