Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE)
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ClinicalTrials.gov Identifier: NCT01077154 |
Recruitment Status
:
Active, not recruiting
First Posted
: February 26, 2010
Last Update Posted
: November 30, 2017
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Tracking Information | ||||
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First Submitted Date ICMJE | February 4, 2010 | |||
First Posted Date ICMJE | February 26, 2010 | |||
Last Update Posted Date | November 30, 2017 | |||
Actual Study Start Date ICMJE | June 2, 2010 | |||
Actual Primary Completion Date | August 31, 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Bone metastasis-free survival [ Time Frame: 7 years, 3 months ] | |||
Original Primary Outcome Measures ICMJE |
Bone metastasis-free survival [ Time Frame: 6 years, 3 months ] | |||
Change History | Complete list of historical versions of study NCT01077154 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE) | |||
Official Title ICMJE | 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 | Rationale: For women with early-stage breast cancer, bone is a frequent site of relapse, and most women with advanced breast cancer will eventually develop disease in the bone. Denosumab, a fully human monoclonal antibody that specifically inhibits RANK ligand, may have the potential to interrupt the hypothetical "vicious cycle" of cancer-induced bone destruction and tumor cell expansion through the bone. It is not yet known if denosumab may prevent disease recurrence in the bone or in any other part of the body. Purpose: 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. |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Breast Cancer | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Actual Enrollment ICMJE |
4509 | |||
Original Estimated Enrollment ICMJE |
4500 | |||
Estimated Study Completion Date | August 24, 2022 | |||
Actual Primary Completion Date | August 31, 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Definitive treatment must be planned to be completed within approximately 9 months of randomization
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Latvia, Malaysia, Mexico, Netherlands, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Slovenia, South Africa, Spain, Taiwan, Turkey, United Kingdom, United States | |||
Removed Location Countries | Czech Republic | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01077154 | |||
Other Study ID Numbers ICMJE | 20060359 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Amgen | |||
Study Sponsor ICMJE | Amgen | |||
Collaborators ICMJE | Daiichi Sankyo, Inc. | |||
Investigators ICMJE |
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PRS Account | Amgen | |||
Verification Date | November 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |