NRG-BR007

Clinical Trial Title A Phase III Clinical Trial Evaluating DE-escalation of Breast RAdiation (DEBRA) for Conservative Treatment of Stage I, Hormone Sensitive, HER2-Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer
Trial Status Open to Enrollment
Start Date 12/27/2022
Location All Hospitals
Trial Type Cancer - Adult Oncology
Specific Condition Breast Cancer
Description 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.
Eligibility Criteria

Eligibility Criteria

  • The patient must be ≥ 50 years and < 70 years of age.
  • The trial is open to female and male patients.
  • 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.)
  • Patient must have undergone axillary staging (sentinel node biopsy and/or axillary node dissection).
  • 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 ≥ 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.

Ineligibility Criteria

Patients with any of the following conditions are NOT eligible for this study.

  • Definitive clinical or radiologic evidence of metastatic disease.
  • pT2 - pT4 tumors including inflammatory breast cancer.
  • Patient had a mastectomy.
  • Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.
IRB Number Central IRB
Notes De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA) - Full Text View - ClinicalTrials.gov
Principal Investigator Andrew Kee, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org