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NCT04852887 · ClinicalTrials.gov registry record · Phase 3
De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)
A Phase 3 study of Stage I Breast Cancer, sponsored by NRG Oncology.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,670
- Enrollment target
- 20
- Study locations
NCT04852887: Recruiting Phase 3 study of Stage I Breast Cancer, sponsored by NRG Oncology.
NCT04852887 is a Phase 3 study of Stage I Breast Cancer that is actively recruiting participants, run by NRG Oncology. The registered enrollment target is 1,670 participants, above the 78-participant average among 11 other Stage I Breast Cancer trials with a reported enrollment target (2041% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04852887, a Phase 3 study of Stage I Breast Cancer, is actively recruiting participants, sponsored by NRG Oncology.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,670 participants
- Enrollment target
- 20
- Study locations
Study Summary
This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy.
Primary Outcome
Time from randomization to any invasive or noninvasive IBTR or last follow-up (expressed as % IBTR-free)
Conditions Studied
Interventions
- OTHER Radiation and Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)
- DRUG Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)
Study Locations (20)
California
- Kaiser Permanente-Anaheim - Anaheim
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- PCR Oncology - Arroyo Grande
- Sutter Auburn Faith Hospital - Auburn
- Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
- Kaiser Permanente-Bellflower - Bellflower
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Tower Cancer Research Foundation - Beverly Hills
- Mercy Cancer Center - Carmichael - Carmichael
- Mercy San Juan Medical Center - Carmichael
- Epic Care-Dublin - Dublin
- Kaiser Permanente Dublin - Dublin
- Mercy Cancer Center - Elk Grove - Elk Grove
Arizona
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
- Mayo Clinic Hospital in Arizona - Phoenix
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
- University of South Alabama Mitchell Cancer Institute - Mobile
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,670 participants |
| Start Date | 2021-06-07 |
| Est. Completion | 2041-07 |
| Phase | Phase 3 |
What NCT04852887 shows while recruiting
NCT04852887 is an interventional study that assigns participants to a tested intervention. Its 1,670 participants enrollment target places it among the larger protocols in the corpus, above the 78-participant average among 11 other Stage I Breast Cancer trials with a reported enrollment target (2041% higher).
The record links to 1 condition, with Stage I Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Radiation and Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane) is the first listed.
NCT04852887 names 20 study sites across 4 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT04852887 about?
NCT04852887 is a clinical study titled "De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)". This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy.
What is the current status of trial NCT04852887?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,670 participants. The study started on 2021-06-07. Estimated completion is 2041-07.
What conditions does trial NCT04852887 study?
This clinical trial studies the following conditions: Stage I Breast Cancer.
What interventions are being tested in trial NCT04852887?
The interventions under investigation include: Radiation and Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane) (OTHER), Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane) (DRUG).
Who is sponsoring clinical trial NCT04852887?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04852887 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage I 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 NCT04852887's enrollment target sits among peer trials
1,670 1st of 11 higher than 11 of 11 other Stage I Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage I 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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