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NCT04567420 · ClinicalTrials.gov registry record · Phase 2

DNA-guided Second Line Adjuvant Therapy for High Residual Risk, Estrogen Receptor Positive, HER-2 Negative Breast Cancer (DARE)

A Phase 2 study of Breast Cancer, sponsored by Criterium.

Recruiting
Registry status
Phase 2
Development phase
70
Enrollment target
19
Study locations

NCT04567420 is a Phase 2 study of Breast Cancer that is actively recruiting participants, run by Criterium. The registered enrollment target is 70 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 19 study locations across 16 states.

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The verdict

NCT04567420, a Phase 2 study of Breast Cancer, is actively recruiting participants, sponsored by Criterium.

RECRUITING
Registry status
Phase 2
Development phase
70 participants
Enrollment target
19
Study locations

Study Summary

A randomized, Phase II trial of circulating tumor DNA-guided second line Adjuvant therapy for high Residual risk, Estrogen Receptor positive, HER-2 negative breast cancer (DARE)

Conditions Studied

Interventions

  • DRUG Fulvestrant
  • DRUG Palbociclib
  • DRUG Adjuvant Therapy

Study Locations (19)

California

  • USC/Norris Comprehensive Cancer Center - Los Angeles
  • Cedars-Sinai Medical Center - Los Angeles

Colorado

  • University of Colorado Cancer Center - Aurora
  • Intermountain - Golden

New York

  • Icahn School of Medicine at Mount Sinai - New York
  • Stony Brook University Cancer Center - Stony Brook

Arizona

  • University of Arizona Cancer Center - Tucson

Connecticut

  • Yale Cancer Center - New Haven

Georgia

  • Winship Cancer Institute of Emory University - Atlanta

Louisiana

  • Louisiana State University Health Sciences Center- New Orleans - New Orleans

Nebraska

  • Cancer Partners of Nebraska - Lincoln

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2021-02-09
Est. Completion 2028-12-31
Phase Phase 2

Sponsor

Criterium

11 total trials

What the Registry Record Tells You About NCT04567420

The ClinicalTrials.gov registry entry for NCT04567420 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The listed sponsor is Criterium, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Fulvestrant is the first listed.

NCT04567420 reports 19 study locations spanning 16 distinct geographic areas - top geographies include California, Colorado, New York.

Frequently Asked Questions

What is clinical trial NCT04567420 about?

NCT04567420 is a clinical study titled "DNA-guided Second Line Adjuvant Therapy for High Residual Risk, Estrogen Receptor Positive, HER-2 Negative Breast Cancer (DARE)". A randomized, Phase II trial of circulating tumor DNA-guided second line Adjuvant therapy for high Residual risk, Estrogen Receptor positive, HER-2 negative breast cancer (DARE)

What is the current status of trial NCT04567420?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2021-02-09. Estimated completion is 2028-12-31.

What conditions does trial NCT04567420 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT04567420?

The interventions under investigation include: Fulvestrant (DRUG), Palbociclib (DRUG), Adjuvant Therapy (DRUG).

Who is sponsoring clinical trial NCT04567420?

This trial is sponsored by Criterium, which has 11 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04567420 being conducted?

This trial has 19 study locations across Arizona, California, Colorado, Connecticut, Georgia. 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

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.