RecruitingStage I Breast Cancer

De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)

Eligible age

50–70 yrs

Accepts

All genders

Locations

49 states

Healthy volunteers

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About this study

This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy.

Sponsor: NRG Oncology

You may qualify if…

✓ • 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.)

You may not qualify if…

✕ • 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.)