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Hormone Therapy

Radiation and Endocrine Therapy for Breast Cancer(DEBRA Trial)

Phase 3
Recruiting
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must have undergone axillary staging (sentinel node biopsy and/or axillary node dissection).
The following staging criteria must be met postoperatively according to AJCC 8th edition criteria: By pathologic evaluation, primary tumor must be pT1 (less than or equal to 2 cm).
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upthrough study completion, an average of 15 years.
Awards & highlights
Pivotal Trial
No Placebo-Only Group

DEBRA Trial Summary

This trial is testing whether a combination of surgery and hormone therapy is non-inferior to surgery, hormone therapy, and radiation for treating breast cancer.

Eligible Conditions
  • Breast Cancer

DEBRA Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

DEBRA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 15 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 15 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to invasive or noninvasive IBTR.
Secondary outcome measures
Breast
Time from randomization to any death.
Time from randomization to diagnosis of a local, regional or distant recurrence as a first cancer event.
+2 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

DEBRA Trial Design

2Treatment groups
Active Control
Group I: Arm 1: Breast Radiation Therapy + Endocrine TherapyActive Control1 Intervention
Radiation therapy to the breast and hormonal drug for at least 5 years. Tamoxifen 20 mg daily Anastrozole 1 mg daily Letrozole 2.5 mg daily Exemestane 25 mg daily
Group II: Arm 2: No Breast Radiation Therapy + Endocrine TherapyActive Control1 Intervention
No radiation therapy, only hormonal drug for at least 5 years. Tamoxifen 20 mg daily Anastrozole 1 mg daily Letrozole 2.5 mg daily Exemestane 25 mg daily

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor
226 Previous Clinical Trials
98,248 Total Patients Enrolled
9 Trials studying Breast Cancer
11,638 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,487 Previous Clinical Trials
41,265,101 Total Patients Enrolled
934 Trials studying Breast Cancer
1,540,727 Patients Enrolled for Breast Cancer

Media Library

Anastrozol (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04852887 — Phase 3
Breast Cancer Research Study Groups: Arm 1: Breast Radiation Therapy + Endocrine Therapy, Arm 2: No Breast Radiation Therapy + Endocrine Therapy
Breast Cancer Clinical Trial 2023: Anastrozol Highlights & Side Effects. Trial Name: NCT04852887 — Phase 3
Anastrozol (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04852887 — Phase 3
Breast Cancer Patient Testimony for trial: Trial Name: NCT04852887 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project only seeking volunteers who are under 45 years old?

"This particular trial is only looking for patients aged 50 to 70. Out of the 3,633 clinical trials available, 239 are specific for children and adolescents while 3,394 focus on elderly patients."

Answered by AI

Are there any similar cases to Arm 2 in which no breast radiation therapy was combined with endocrine therapy?

"The research team at Queen Mary University of London first began studying Arm 2: No Breast Radiation Therapy + Endocrine Therapy in 1994. In terms of global clinical trial activity, 434 have completed while 235 are ongoing. The city with the most active clinical trials is Chicago, Illinoiso Breast Radiation Therapy + Endocrine Therapy in 1994. In terms of global clinical trial activity, 434 have completed while 235 are ongoing. The city with the most active clinical trials is Chicago, Illinois."

Answered by AI

Do the benefits of Arm 2: No Breast Radiation Therapy + Endocrine Therapy outweigh the risks for patients?

"Arm 2: No Breast Radiation Therapy + Endocrine Therapy receives a safety score of 3 from Power. This is indicative of strong safety data, as it comes from a Phase 3 trial which means that there is both efficacy and multiple rounds of supportive safety data."

Answered by AI

Is this clinical trial only taking place in the United States?

"There are many sites associated with this trial, but some of the notable ones include Northwestern University in Chicago, Illinois; Capital Health Medical Center-Hopewell in Pennington, Wisconsin; and Cancer Care Specialists of Illinois - Decatur in Decatur, Coloradogo, Illinois; Capital Health Medical Center-Hopewell in Pennington, Wisconsin; and Cancer Care Specialists of Illinois - Decatur in Decatur, Colorado."

Answered by AI

Who does this trial hope to attract as participants?

"This clinical trial is looking for 1670 breast cancer patients between the ages of 50 and 70. Candidates must meet the following criteria: The patient must have an ECOG performance status of 0 or 1, The patient must have undergone a lumpectomy and the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS with no ink on tumor as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. (Patients with margins positive for LCIS are eligible without additional rese"

Answered by AI

How many individuals are able to enroll in this research project?

"In order to obtain accurate results, 1670 patients must participate in this trial and meet the pre-defined eligibility criteria. These individuals can enrol at various sites, such as Northwestern University located in Chicago, Illinois or Capital Health Medical Center-Hopewell situated in Pennington, Wisconsin, Illinois or Capital Health Medical Center-Hopewell situated in Pennington, Wisconsin."

Answered by AI

What is the Arm 2: No Breast Radiation Therapy + Endocrine Therapy protocol typically used to manage?

"Arm 2 of this clinical trial will test the efficacy of forgoing radiation therapy and instead relying on endocrine therapy. This approach is most often used to treat aggressive neoplasms, but has also shown some success in treating ovarian cancer, tamoxifen-resistance, and high risk patients."

Answered by AI

Who else is applying?

What state do they live in?
California
Arizona
What site did they apply to?
Cancer Center at Saint Joseph's
Epic Care Partners in Cancer Care
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I would love to help the breast cancer community gain more insight. I am stage 2b. Not sure if I qualify with tumor size of 2.5 cm.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)
2021. "De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04852887.
All > Breast Cancer High Point > Delaware
~773 spots leftby Jan 2026
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