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Hormone Therapy

Hormone Therapy with or without Radiation 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
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). By pathologic evaluation, ipsilateral nodes must be pN0. (Patients with pathologic staging of pN0(i+) or pN0(mol+) are NOT eligible.)
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 resection.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 15 years.
Awards & highlights

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.

Who is the study for?
This trial is for individuals with hormone-sensitive, HER-2 negative breast cancer and an Oncotype Recurrence Score of 18 or less. Participants must have had a lumpectomy with clear margins, no metastatic disease, no prior breast radiation, and be able to start treatment within 70 days post-surgery. They should not have received any previous treatments for their current cancer.Check my eligibility
What is being tested?
The DEBRA Phase III Trial is testing if endocrine therapy alone after breast conservation surgery is as effective in preventing tumor recurrence as the combination of endocrine therapy with radiation. The goal is to see if radiation can be safely omitted without increasing the risk of cancer returning.See study design
What are the potential side effects?
Endocrine therapies like Tamoxifen and aromatase inhibitors may cause hot flashes, mood swings, fatigue, joint pain, and bone thinning. Radiation can lead to skin changes like redness and irritation in the treated area along with potential fatigue.

DEBRA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer was found to be at an early stage with a small tumor and no spread to nearby lymph nodes.
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I had a lumpectomy with clear margins and no cancer cells at the edges.
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My surgical wound has fully healed without any infection.
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I had a lumpectomy and the edges of the removed tissue are cancer-free.
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My tumor is 0.5 cm or smaller and I need to send a sample for Oncotype DX testing.
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I am fully active or able to carry out light work.
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My cancer's recurrence risk score is 18 or lower.
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My cancer was found to be at an early stage and the tumor is small.
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I have had surgery to check the lymph nodes under my arm.
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My cancer has not spread to nearby lymph nodes.
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My tumor is estrogen or progesterone receptor positive.
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My tumor is not HER2 positive according to recent guidelines.
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My breast cancer is invasive and affects only one breast.

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

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
231 Previous Clinical Trials
99,182 Total Patients Enrolled
9 Trials studying Breast Cancer
11,638 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,924,403 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 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, 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, 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."

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
~619 spots leftby Jan 2026
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