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NCT01077154 · ClinicalTrials.gov registry record · Phase 3
Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE)
A Phase 3 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 3
- Development phase
- 4,509
- Enrollment target
NCT01077154: Clinical Trial Phase 3 study, sponsored by Amgen.
NCT01077154 is a Phase 3 study that was terminated before completion, run by Amgen. The registered enrollment target is 4,509 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (484% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01077154, a Phase 3 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 4,509 participants
- Enrollment target
Study Summary
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.
Primary Outcome
BMFS time was defined as the time interval from the randomization date to the first occurrence of bone metastasis or death from any cause, whichever came first. Participants last known to be alive with no bone metastasis were censored at their last assessment date, or at the primary analysis data cut-off date, whichever was first. Participants who had first occurrence of bone metastasis before randomization were censored at their randomization date. Bone metastasis must have been confirmed by c
Interventions
- DRUG Placebo
- DRUG Denosumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,509 participants |
| Start Date | 2010-06-02 |
| Est. Completion | 2018-03-26 |
| Phase | Phase 3 |
Why NCT01077154 stopped before completion
NCT01077154 is an interventional study that assigns participants to a tested intervention. Its 4,509 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (484% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01077154 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01077154 about?
NCT01077154 is a clinical study titled "Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE)". 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.
What is the current status of trial NCT01077154?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 4,509 participants. The study started on 2010-06-02. Estimated completion is 2018-03-26.
What interventions are being tested in trial NCT01077154?
The interventions under investigation include: Placebo (DRUG), Denosumab (DRUG).
Who is sponsoring clinical trial NCT01077154?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01077154's enrollment target sits among peer trials
4,509 55th of 2000 higher than 1,946 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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