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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 is a Phase 3 study that was terminated before completion, run by Amgen. The registered enrollment target is 4,509 participants.

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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.

Interventions

  • DRUG Placebo
  • DRUG Denosumab

Trial Details

FieldValue
Enrollment Target 4,509 participants
Start Date 2010-06-02
Est. Completion 2018-03-26
Phase Phase 3

Sponsor

Amgen

558 total trials

What the Registry Record Tells You About NCT01077154

The ClinicalTrials.gov registry entry for NCT01077154 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 4,509 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01077154 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.