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RECRUITING Phase 2

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

NCT04567420 · View on ClinicalTrials.gov ↗

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

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04567420

The ClinicalTrials.gov registry entry for NCT04567420 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Criterium, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04567420 reports 19 study locations spanning 16 distinct geographic areas — top geographies include California, Colorado, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04567420?

The interventions under investigation include: Fulvestrant (DRUG), Palbociclib (DRUG), Adjuvant Therapy (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04567420?

This trial is sponsored by Criterium, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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