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NCT05467891 · ClinicalTrials.gov registry record · Phase 2

Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer

A Phase 2 study of HER2-Negative Breast Cancer and Hormone Receptor-Positive Breast Cancer, sponsored by Oana Danciu.

Recruiting
Registry status
Phase 2
Development phase
200
Enrollment target
20
Study locations

NCT05467891 is a Phase 2 study of HER2-Negative Breast Cancer and Hormone Receptor-Positive Breast Cancer that is actively recruiting participants, run by Oana Danciu. The registered enrollment target is 200 participants, below the 251-participant average among 49 other HER2-Negative Breast Cancer trials with a reported enrollment target (20% lower). The trial reports 20 study locations across 18 states.

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The verdict

NCT05467891, a Phase 2 study of HER2-Negative Breast Cancer and Hormone Receptor-Positive Breast Cancer, is actively recruiting participants, sponsored by Oana Danciu.

RECRUITING
Registry status
Phase 2
Development phase
200 participants
Enrollment target
20
Study locations

Study Summary

This is an open label, multicenter, single arm phase II study to evaluate the efficacy and safety of ribociclib and ET in patients with locoregional recurrence of HR-positive, HER2-negative breast cancer.

Interventions

  • DRUG Anastrozole
  • DRUG Letrozole
  • DRUG Exemestane
  • DRUG Fulvestrant
  • DRUG Ribociclib

Study Locations (20)

Michigan

  • University of Michigan Health System - Ann Arbor
  • University of Michigan Health-West - Wyoming

Virginia

  • University of Virginia Health System - Charlottesville
  • Virginia Commonwealth University - Richmond

Alabama

  • University of Alabama at Birmingham - Birmingham

Arizona

  • University of Arizona - Phoenix

Florida

  • Orlando Health Cancer Institute - Orlando

Illinois

  • University of Illinois Cancer Center - Chicago

Indiana

  • Parkview Research Center - Fort Wayne

Iowa

  • University of Iowa Hospitals and Clinics - Iowa City

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2022-09-13
Est. Completion 2029-08
Phase Phase 2

Sponsor

Oana Danciu

1 total trials

What the Registry Record Tells You About NCT05467891

The ClinicalTrials.gov registry entry for NCT05467891 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 251-participant average among 49 other HER2-Negative Breast Cancer trials with a reported enrollment target (20% lower). The listed sponsor is Oana Danciu, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with HER2-Negative Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Anastrozole is the first listed.

NCT05467891 reports 20 study locations spanning 18 distinct geographic areas - top geographies include Michigan, Virginia, Alabama.

Frequently Asked Questions

What is clinical trial NCT05467891 about?

NCT05467891 is a clinical study titled "Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer". This is an open label, multicenter, single arm phase II study to evaluate the efficacy and safety of ribociclib and ET in patients with locoregional recurrence of HR-positive, HER2-negative breast cancer.

What is the current status of trial NCT05467891?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2022-09-13. Estimated completion is 2029-08.

What conditions does trial NCT05467891 study?

This clinical trial studies the following conditions: HER2-Negative Breast Cancer, Hormone Receptor-Positive Breast Cancer, Locoregional Recurrence.

What interventions are being tested in trial NCT05467891?

The interventions under investigation include: Anastrozole (DRUG), Letrozole (DRUG), Exemestane (DRUG), Fulvestrant (DRUG), Ribociclib (DRUG).

Who is sponsoring clinical trial NCT05467891?

This trial is sponsored by Oana Danciu, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05467891 being conducted?

This trial has 20 study locations across Alabama, Arizona, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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