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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: Recruiting Phase 2 study of Breast Cancer, sponsored by Criterium.
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. According to ClinicalTrials.gov, the official US trial registry.
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)
Primary Outcome
Primary objective of the ctDNA screening (surveillance) phase is to assess the incidence of ctDNA detection (i.e. ctDNA positivity) in patients with ER positive HER2- breast cancer who are receiving standard of care adjuvant endocrine therapy but remain high risk for recurrence.
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
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2021-02-09 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 2 |
What NCT04567420 shows while recruiting
NCT04567420 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
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 lists 19 locations in 16 states (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.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04567420's enrollment target sits among peer trials
70 696th of 1224 higher than 521 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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.
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