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
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
There are no treatments specifically approved after recurrence or progression on a non steroidal aromatase inhibitors (NSAI). In light of the need for new treatment options for postmenopausal women after failure of prior NSAI therapy, the purpose of this Phase III study is to compare efficacy and safety of a treatment with exemestane + everolimus to exemestane + placebo in postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer refractory to NSAI.
Study identification
- NCT ID
- NCT00863655
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 724 participants
Conditions and interventions
Conditions
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 3, 2009 (Actual)
- Primary completion
- Dec 4, 2014 (Actual)
- Completion
- Dec 4, 2014 (Actual)
- Last update posted
- May 2, 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 2, 2017 · Synced Oct 30, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00863655 live on ClinicalTrials.gov.