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Terminated Phase 3 Interventional Results available

Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE)

ClinicalTrials.gov ID: NCT01077154

Public ClinicalTrials.gov record NCT01077154. 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 Sep 4, 2026, 9:57 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, Multi-Center Phase 3 Study of Denosumab as Adjuvant Treatment for Women With Early-Stage Breast Cancer at High Risk of Recurrence (D-CARE)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This randomized phase 3 trial is studying the effect of denosumab to see if it can prevent disease recurrence in the bone or in any other part of the body, when it is given as adjuvant therapy for women with early-stage breast cancer, who are at high risk of disease recurrence.

Study identification

NCT ID
NCT01077154
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
Amgen
Industry
Enrollment
4,509 participants

Conditions and interventions

Conditions

Interventions

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 1, 2010
Primary completion
Aug 30, 2017
Completion
Mar 25, 2018
Last update posted
Sep 27, 2021

2010 – 2018

United States locations

U.S. sites
93
U.S. states
35
U.S. cities
84
Facility City State ZIP Site status
Research Site Birmingham Alabama 35205
Research Site Tucson Arizona 85724
Research Site Jonesboro Arkansas 72401
Research Site Alhambra California 91801
Research Site Anaheim California 92801
Research Site Beverly Hills California 90211
Research Site Campbell California 95008
Research Site Fresno California 93720
Research Site Fullerton California 92835
Research Site La Verne California 91750
Research Site Lancaster California 93534
Research Site Long Beach California 90813
Research Site Los Angeles California 90024
Research Site Los Angeles California 90025
Research Site Los Angeles California 90095-1772
Research Site Northridge California 91328
Research Site Redondo Beach California 90277
Research Site Santa Barbara California 93105
Research Site Santa Maria California 93454
Research Site Torrance California 90502
Research Site Denver Colorado 80220
Research Site Grand Junction Colorado 81501
Research Site New Haven Connecticut 06510
Research Site Boynton Beach Florida 33435
Research Site Coral Springs Florida 33065
Research Site Fort Lauderdale Florida 33316
Research Site Hollywood Florida 33021
Research Site Jacksonville Florida 32256
Research Site Melbourne Florida 32901
Research Site Athens Georgia 30607
Research Site Niles Illinois 60714
Research Site Indianapolis Indiana 46260
Research Site Cedar Rapids Iowa 52402
Research Site Hutchinson Kansas 67502
Research Site Wichita Kansas 67214
Research Site Paducah Kentucky 42003
Research Site Annapolis Maryland 21401
Research Site Baltimore Maryland 21201
Research Site Bethesda Maryland 20817
Research Site Columbia Maryland 21044
Research Site Boston Massachusetts 02114
Research Site Danvers Massachusetts 01923
Research Site Ann Arbor Michigan 48109
Research Site Detroit Michigan 48201
Research Site Edina Minnesota 55435
Research Site Minneapolis Minnesota 55407
Research Site Saint Louis Park Minnesota 55426
Research Site Jackson Mississippi 39202
Research Site Jefferson City Missouri 65109
Research Site Lincoln Nebraska 68510
Research Site Henderson Nevada 89052
Research Site Lebanon New Hampshire 03756-0001
Research Site Denville New Jersey 07834
Research Site Hackensack New Jersey 07601
Research Site East Setauket New York 11733
Research Site New York New York 10003
Research Site New York New York 10029
Research Site New York New York 10032
Research Site Nyack New York 10960
Research Site Asheville North Carolina 28806
Research Site High Point North Carolina 27262
Research Site Cincinnati Ohio 45242
Research Site Columbus Ohio 43210
Research Site Tulsa Oklahoma 74136
Research Site Hershey Pennsylvania 17033
Research Site Pittsburgh Pennsylvania 15213
Research Site Pawtucket Rhode Island 02860
Research Site Charleston South Carolina 29414
Research Site Columbia South Carolina 29210
Research Site Hilton Head Island South Carolina 29926
Research Site Sioux Falls South Dakota 57105
Research Site Chattanooga Tennessee 37404
Research Site Germantown Tennessee 38138
Research Site Nashville Tennessee 37203
Research Site Abilene Texas 79606-5208
Research Site Corpus Christi Texas 78463
Research Site Dallas Texas 75230-2510
Research Site Dallas Texas 75246
Research Site Dallas Texas 75390
Research Site El Paso Texas 79902
Research Site Garland Texas 75042
Research Site Houston Texas 77024
Research Site Houston Texas 77030
Research Site Plano Texas 75075
Research Site San Antonio Texas 78217
Research Site San Antonio Texas 78229
Research Site Tyler Texas 75702
Research Site Richlands Virginia 24641
Research Site Richmond Virginia 23230
Research Site Roanoke Virginia 24014
Research Site Seattle Washington 98109-1023
Research Site Seattle Washington 98133
Research Site Tacoma Washington 98405

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 366 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01077154, 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 Sep 27, 2021 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01077154 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →