De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)
Launched by NRG ONCOLOGY · Apr 20, 2021
Trial Information
Current as of July 24, 2025
Recruiting
Keywords
ClinConnect Summary
The DEBRA trial is a research study looking at a different approach to treating early-stage hormone-sensitive breast cancer. Specifically, it aims to find out if women who have had breast-conserving surgery and receive hormone therapy (called endocrine therapy) can have similar outcomes in terms of cancer recurrence as those who receive the same surgery and hormone therapy but also undergo radiation therapy. This is important because if the results show that radiation is not necessary for certain patients, it could lead to less intensive treatment options with fewer side effects.
To be eligible for this trial, participants must have been diagnosed with a specific type of early-stage breast cancer (Stage I) and meet criteria such as having had a lumpectomy with clear surgical margins and a low Oncotype DX Recurrence Score (18 or less), which helps assess the risk of cancer returning. Participants can be of any gender and must be willing to commit to hormone therapy for at least five years. The trial is currently recruiting participants, and those who join can expect to have regular follow-ups to monitor their health and outcomes over time. If you're considering participation, it's essential to discuss it with your doctor to see if it might be the right choice for you.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • • The patient or a legally authorized representative must provide study-specific informed consent prior to pre-entry/Step 1 and, for patients treated in the U.S., authorization permitting release of personal health information.
- • 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 resection.)
- • The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
- • 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).
- • By pathologic evaluation, ipsilateral nodes must be pN0. (Patients with pathologic staging of pN0(i+) or pN0(mol+) are NOT eligible.)
- • Oncotype DX Recurrence Score of less than or equal to 18 on diagnostic core biopsy or resected specimen.
- • \*\* For patients with a T1a tumor (less than or equal to 0.5 cm in size) or patients at Canadian provinces or approved international sites where Oncotype DX Recurrence Score testing would not be covered, who do not already have an Oncotype DX Recurrence Score at pre-entry/Step 1, a specimen (unstained blocks or slides) must be sent to the Genomic Health centralized laboratory. Tumor size sample must be greater than or equal to 0.2 cm for analysis.
- • \*\*\* The Oncotype RS can be run on the biopsy core or surgical specimen. The patient cannot have initiated endocrine therapy prior to tissue collection.
- • An Oncotype RS is required for eligibility, however, for a patient whose tumor has already had a MammaPrint test completed as part of usual care when being considered for enrollment and is in the binary "Low" category will meet this eligibility criteria and an Oncotype RS does not need to be performed.
- • The tumor must have been determined to be ER and/or PgR positive assessed by current ASCO/CAP Guideline Recommendations for hormone receptor testing. Patients with greater than or equal to 1% ER or PgR staining by IHC are considered positive.
- • The tumor must have been determined to be HER2-negative by current ASCO/CAP guidelines.
- * Patients may be premenopausal or postmenopausal at the time of pre-entry/Step 1. For study purposes, postmenopausal is defined as:
- • Age 56 or older with no spontaneous menses for at least 12 months prior to pre-entry/Step 1; or a documented hysterectomy; or
- • Age 55 or younger with no spontaneous menses for at least 12 months prior to pre-entry/Step 1 (e.g., spontaneous or secondary to hysterectomy) and with a documented estradiol level in the postmenopausal range according to local institutional/laboratory standard; or Documented bilateral oophorectomy.
- • The interval between the last surgery for breast cancer (including re-excision of margins) and pre-entry/Step 1 must be no more than 70 days.
- • The patient must have recovered from surgery with the incision completely healed and no signs of infection.
- • Bilateral mammogram or MRI within 6 months prior to pre-entry/Step 1. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Patients must be intending to take endocrine therapy for a minimum 5 years duration (tamoxifen or aromatase inhibitor). The specific regimen of endocrine therapy is at the treating physician's discretion.
- Exclusion Criteria:
- • • Definitive clinical or radiologic evidence of metastatic disease.
- • pT1 mi and pT2 - pT4 tumors including inflammatory breast cancer.
- • Pathologic staging of pN0(i+) or pN0(mol+), pN1, pN2, or pN3 disease.
- • Patient had a mastectomy.
- • Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
- • Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
- • Non-epithelial breast malignancies such as sarcoma or lymphoma.
- • Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters. (Patients with multifocal carcinoma are eligible.)
- • Paget's disease of the nipple.
- • Any history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated or not treated. (Patients with synchronous or previous ipsilateral LCIS are eligible.)
- • Synchronous or previous contralateral invasive breast cancer or DCIS. (Patients with synchronous and/or previous contralateral LCIS are eligible.)
- • Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re- excision, the patient is eligible.)
- • Treatment plan that includes regional nodal irradiation.
- • Any treatment with radiation therapy, chemotherapy, or biotherapy, administered for the currently diagnosed breast cancer prior to pre-entry/Step 1.
- • History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to pre-entry/Step 1.
- • Current therapy with any endocrine therapy such as raloxifene (Evista®), tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or breast cancer prevention.
- \*\* Patients are eligible for BR007 if they receive a short course of preoperative endocrine therapy of less than 6 weeks duration (prior to randomization/Step 2) for this diagnosis after the core biopsy (and can continue postoperatively if:
- • the Oncotype DX Recurrence Score is assessed on the biopsy core and is less than or equal to 18, AND
- • the patient had not initiated endocrine therapy prior to core biopsy tissue collection.
- • \*\*\* This does not apply to adjuvant endocrine therapy recommended for this diagnosis which may start any time after surgery including prior to registration (Pre-entry/Step 1).
- • Patients intending to continue on oral, transdermal, or subdermal estrogen replacement (including all estrogen only and estrogen-progesterone formulas) are not eligible. Patients that discontinue oral, transdermal, or subdermal estrogen replacement prior to registration are eligible.
- • Prior breast or thoracic RT for any condition.
- • Active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
- • Pregnancy or lactation at the time of pre-entry/Step 1 or intention to become pregnant during treatment. (Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 2 weeks prior to pre-entry/Step 1.)
- • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of study therapy or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
- • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results.
- • Use of any investigational product within 30 days prior to pre-entry/Step 1.
About Nrg Oncology
NRG Oncology is a prominent clinical trial sponsor dedicated to advancing cancer research through innovative multi-institutional studies. Comprising a collaborative network of leading academic institutions and community hospitals, NRG Oncology focuses on enhancing patient outcomes by conducting rigorous clinical trials that evaluate new treatment strategies and improve existing therapies. With a commitment to scientific excellence and patient-centered care, the organization plays a vital role in shaping the future of oncology by integrating cutting-edge research with clinical practice, ultimately striving to translate findings into meaningful improvements in cancer care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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Fremont, California, United States
Wexford, Pennsylvania, United States
Milwaukee, Wisconsin, United States
'Aiea, Hawaii, United States
Avon, Indiana, United States
Menomonee Falls, Wisconsin, United States
Mukwonago, Wisconsin, United States
West Bend, Wisconsin, United States
'Aiea, Hawaii, United States
Waukesha, Wisconsin, United States
Ontario, California, United States
Trumbull, Connecticut, United States
Des Moines, Iowa, United States
Overland Park, Kansas, United States
Westwood, Kansas, United States
Kernersville, North Carolina, United States
Mount Airy, North Carolina, United States
Thomasville, North Carolina, United States
Akashi City, Hyogo, Japan
Columbia, Maryland, United States
Binghamton, New York, United States
Albert Lea, Minnesota, United States
Rochester, New York, United States
Phoenix, Arizona, United States
Winter Haven, Florida, United States
Chambersburg, Pennsylvania, United States
Midlothian, Virginia, United States
Orland Park, Illinois, United States
Coral Gables, Florida, United States
Deerfield Beach, Florida, United States
Plainfield, Illinois, United States
Glen Burnie, Maryland, United States
Charlotte, North Carolina, United States
North Kansas City, Missouri, United States
Jefferson Hills, Pennsylvania, United States
Bay Shore, New York, United States
Phoenix, Arizona, United States
Elk Grove, California, United States
Rocklin, California, United States
Sacramento, California, United States
San Luis Obispo, California, United States
Santa Maria, California, United States
Woodland, California, United States
Tawas City, Michigan, United States
Las Vegas, Nevada, United States
Moorestown, New Jersey, United States
Willow Grove, Pennsylvania, United States
Brewer, Maine, United States
Warrensville Heights, Ohio, United States
Seattle, Washington, United States
Rock Hill, South Carolina, United States
New York, New York, United States
Derby, Connecticut, United States
Fairfield, Connecticut, United States
Guilford, Connecticut, United States
North Haven, Connecticut, United States
Orange, Connecticut, United States
Waterbury, Connecticut, United States
Waterford, Connecticut, United States
Dekalb, Illinois, United States
Mount Pleasant, Michigan, United States
Albemarle, North Carolina, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
High Point, North Carolina, United States
Beavercreek, Ohio, United States
Stevens Point, Wisconsin, United States
Statesville, North Carolina, United States
Abilene, Texas, United States
Johns Creek, Georgia, United States
Clarkston, Michigan, United States
Farmington Hills, Michigan, United States
Troy, Michigan, United States
New Bern, North Carolina, United States
Hilton Head Island, South Carolina, United States
Arroyo Grande, California, United States
Greenwich, Connecticut, United States
Pompton, New Jersey, United States
Bluffton, South Carolina, United States
Medford, Wisconsin, United States
Sarasota, Florida, United States
Plantation, Florida, United States
Port Huron, Michigan, United States
Honolulu, Hawaii, United States
Mooresville, Indiana, United States
Bellevue, Nebraska, United States
Omaha, Nebraska, United States
Easton, Pennsylvania, United States
Mechanicsville, Virginia, United States
Mechanicsville, Virginia, United States
Lake Forest, Illinois, United States
Brighton, Michigan, United States
Oak Creek, Wisconsin, United States
San Jose, California, United States
Chadds Ford, Pennsylvania, United States
Libertyville, Illinois, United States
Gunma, Maebashi, Japan
Kingman, Arizona, United States
Fort Myers, Florida, United States
Washington, Illinois, United States
Farmington, Missouri, United States
Redwood City, California, United States
Santa Cruz, California, United States
Tarzana, California, United States
Colorado Springs, Colorado, United States
Englewood, Colorado, United States
Fort Collins, Colorado, United States
Greeley, Colorado, United States
Frankford, Delaware, United States
Burnsville, Minnesota, United States
Lincoln, Nebraska, United States
Richmond, Virginia, United States
Salisbury, North Carolina, United States
Bozeman, Montana, United States
Hamden, Connecticut, United States
Covington, Louisiana, United States
Ocean Pines, Maryland, United States
Carmichael, California, United States
Stamford, Connecticut, United States
'Ewa Beach, Hawaii, United States
Barrington, Illinois, United States
Crystal Lake, Illinois, United States
Crown Point, Indiana, United States
Dyer, Indiana, United States
Hobart, Indiana, United States
Hobart, Indiana, United States
Munster, Indiana, United States
Valparaiso, Indiana, United States
East Hills, New York, United States
Oneida, New York, United States
Oswego, New York, United States
Sleepy Hollow, New York, United States
Clemmons, North Carolina, United States
East Norriton, Pennsylvania, United States
Baytown, Texas, United States
Houston, Texas, United States
Nassau Bay, Texas, United States
The Woodlands, Texas, United States
Glastonbury, Connecticut, United States
Ocoee, Florida, United States
New York, New York, United States
Westerly, Rhode Island, United States
Vancouver, Washington, United States
Forest City, North Carolina, United States
Highlands Ranch, Colorado, United States
Macomb, Michigan, United States
Missoula, Montana, United States
Torrance, California, United States
Lone Tree, Colorado, United States
Greenlawn, New York, United States
Aventura, Florida, United States
Aventura, Florida, United States
Alton, Illinois, United States
Madison Heights, Michigan, United States
Newnan, Georgia, United States
Stockbridge, Georgia, United States
Brooklyn, New York, United States
Venice, Florida, United States
Alpharetta, Georgia, United States
Canton, Georgia, United States
'Aiea, Hawaii, United States
Denver, Colorado, United States
Omaha, Nebraska, United States
Lexington, Kentucky, United States
Aurora, Colorado, United States
Shiloh, Illinois, United States
Sheboygan, Wisconsin, United States
Meadville, Pennsylvania, United States
Matthews, North Carolina, United States
Mineola, New York, United States
Astoria, New York, United States
Quakertown, Pennsylvania, United States
Avon, Ohio, United States
Sarasota, Florida, United States
Des Moines, Iowa, United States
Allentown, Pennsylvania, United States
Lebanon, New Hampshire, United States
Sheboygan, Wisconsin, United States
Wyoming, Michigan, United States
Grand Rapids, Michigan, United States
Muskegon, Michigan, United States
Troy, Ohio, United States
Nampa, Idaho, United States
Pontiac, Michigan, United States
Ann Arbor, Michigan, United States
Brighton, Michigan, United States
Chelsea, Michigan, United States
Centralia, Illinois, United States
Dayton, Ohio, United States
Webster, New York, United States
Danville, Illinois, United States
New Albany, Ohio, United States
Guilford, Connecticut, United States
Orland Park, Illinois, United States
Quakertown, Pennsylvania, United States
Rockville Centre, New York, United States
Greenville, Ohio, United States
Decatur, Georgia, United States
Los Angeles, California, United States
Ames, Iowa, United States
Canton, Michigan, United States
Rhinelander, Wisconsin, United States
Stevens Point, Wisconsin, United States
Minocqua, Wisconsin, United States
Columbia, Missouri, United States
Sarasota, Florida, United States
Sarasota, Florida, United States
Palos Heights, Illinois, United States
Stroudsburg, Pennsylvania, United States
Clarkston, Michigan, United States
Farmington Hills, Michigan, United States
Madison Heights, Michigan, United States
Macomb, Michigan, United States
Verona, New York, United States
Glenview, Illinois, United States
Grayslake, Illinois, United States
Ankeny, Iowa, United States
Sunset Hills, Missouri, United States
Dillon, Colorado, United States
Niles, Michigan, United States
Saint Joseph, Michigan, United States
O'fallon, Illinois, United States
Des Moines, Iowa, United States
Clive, Iowa, United States
Lincoln, Nebraska, United States
Carmichael, California, United States
Shreveport, Louisiana, United States
Grand Rapids, Michigan, United States
Rockford, Illinois, United States
Saint Joseph, Michigan, United States
Jefferson City, Missouri, United States
Pontiac, Michigan, United States
Madison, Wisconsin, United States
Silverdale, Washington, United States
Saint Johnsbury, Vermont, United States
Dayton, Ohio, United States
Dayton, Ohio, United States
Grand Rapids, Michigan, United States
Johnson Creek, Wisconsin, United States
Troy, Michigan, United States
N. Venice, Florida, United States
Bel Air, Maryland, United States
Royal Oak, Michigan, United States
Johnson Creek, Wisconsin, United States
East Hills, New York, United States
Irvine, California, United States
Farmington Hills, Michigan, United States
Troy, Michigan, United States
North Wilkesboro, North Carolina, United States
Sarasota, Florida, United States
Millville, Delaware, United States
Saginaw, Michigan, United States
Tawas City, Michigan, United States
Crown Point, Indiana, United States
Camillus, New York, United States
Golden, Colorado, United States
Okatie, South Carolina, United States
Madison, Wisconsin, United States
Detroit, Michigan, United States
Aurora, Illinois, United States
Kalamazoo, Michigan, United States
Warren, Michigan, United States
Olathe, Kansas, United States
Westminster, Colorado, United States
Ankeny, Iowa, United States
Clive, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
Denver, Colorado, United States
Sheboygan, Wisconsin, United States
Waukee, Iowa, United States
Rolla, Missouri, United States
Littleton, Colorado, United States
Parker, Colorado, United States
Venice, Florida, United States
Showa Ku Nagoya, , Japan
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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