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

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.

Trial Details

NCT ID
NCT04852887
Phase
PHASE3
Sponsor
NRG Oncology
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Radiation and Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)
  • Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Mobile, Alabama, United States|30.69436,-88.04305
  • Kingman, Arizona, United States|35.18944,-114.05301
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Phoenix, Arizona, United States|33.44838,-112.07404

Key Eligibility Criteria

  • • The patient or a legally authorized representative must provide study-specific informed consent prior to pre-entry/Step 1 and, for patients treat…
  • 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 …
  • The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.

For full eligibility, visit ClinicalTrials.gov.

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