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Testing the Usual Treatment of Radiation Therapy and Hormonal Therapy to Hormonal Therapy alone for Low-Risk, Early Stage Breast Cancer, the DEBRA Trial

This phase III trial compares the effect of radiation therapy combined with hormonal therapy versus hormonal therapy alone in treating patients with low risk, early stage breast cancer with Oncotype Dx Recurrence =< 18. Oncotype DX is a laboratory test which results in a score that is used to help predict whether breast cancer will spread to other parts of the body or come back. Radiation therapy uses high doses of radiation to kill cancer cells and shrink tumors but may result in some side effects. Hormones called estrogen and progesterone may contribute to the growth of breast tumor cells. Hormone therapy, also called endocrine therapy, may stop the growth of tumor cells by blocking or removing these hormones. This clinical trial may help researchers understand if patients with low-risk, early stage breast cancer who have Oncotype recurrence score of =< 18 can safely omit radiation therapy and only be treated with hormonal therapy without losing any radiation treatment benefit.
Phase III
Hormonal Therapy, Radiotherapy
Anastrozole, Exemestane, Goserelin acetate (Zoledex), LHRH agonist, Letrozole (Femara), Leuprolide acetate (Lupron), Tamoxifen, Triptorelin
Chak, Bapsi
Vanderbilt University


50 Years
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 United States (U.S.), authorization permitting release of personal health information

The patient must be >= 50 years and 70 years of age

The trial is open to female and male patients

The patient must have an Eastern Cooperative Oncology Group (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 breast ductal carcinoma in situ (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 breast lobular carcinoma in situ [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 American Joint Committee on Cancer (AJCC) 8th edition criteria: * By pathologic evaluation, primary tumor must be pT1 (= 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 = 18 on diagnostic core biopsy or resected specimen. * For patients with a T1a tumor (= 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 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 estrogen receptor (ER) and/or progesterone receptor (PgR) positive assessed by current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guideline Recommendations for hormone receptor testing. Patients with >= 1% ER or PgR staining by immunohistochemistry (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

Human immunodeficiency virus (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 physicians discretion

Exclusion Criteria:

Definitive clinical or radiologic evidence of metastatic disease

pT1mi 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 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 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 radiation therapy (RT) for any condition

Active collagen vascular disease, specifically dermatomyositis with a creatine phosphokinase (CPK) level above normal or with an active skin rash, systemic lupus erythematosus, 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

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trials, call 615-936-8422.