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De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)
NCT04852887 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04852887
The ClinicalTrials.gov registry entry for NCT04852887 describes a study currently listed as recruiting. It is categorized as Phase 3, 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 1,670 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NRG Oncology, which has 162 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 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. 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: NCT04852887 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Arizona, Alabama. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04852887?
This trial is sponsored by NRG Oncology, which has 162 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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