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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.)

Must not have

Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.

Definitive clinical or radiologic evidence of metastatic disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 15 years.

Awards & highlights

No Placebo-Only Group

Pivotal 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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had suspicious breast changes checked and they were not cancer.

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My cancer has spread to other parts of my body, confirmed by tests or scans.

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I have had radiation therapy to my chest or breast before.

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My cancer has spread to nearby lymph nodes.

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I haven't had any cancer other than breast cancer in the last 5 years.

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I have Paget's disease of the nipple.

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I have had a mastectomy.

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My breast cancer is at a stage where it has grown but not spread to distant organs.

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I have suspicious lymph nodes near my breast without confirmed cancer.

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My breast cancer is not the common type but rather a rare form like sarcoma or lymphoma.

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I am currently taking medication like tamoxifen for osteoporosis or to prevent breast cancer.

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I have not received any treatment for my current breast cancer diagnosis before joining this study.

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My treatment plan includes radiation therapy to the lymph nodes.

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I have an active collagen disease like lupus, scleroderma, or dermatomyositis with symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 15 years.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to invasive or noninvasive IBTR.

Secondary study objectives

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

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 27Eligibility criteria met