Testing the usual treatment of radiation therapy and hormonal therapy to hormonal therapy alone for low-risk, early stage breast cancer

DEBRA BR-007
Breast Cancer
Sania Raza, MD
Edward Cancer Center - Naperville
Edward Cancer Center - Plainfield
Nancy Knowles Cancer Center - Elmhurst

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

https://clinicaltrials.gov/ct2/show/NCT04852887

  • Patient must have had a lumpectomy with clear margins 
  • Primary tumor must be pT1 (less than or equal to 2 cm)
  • Tumor must have been ER and/or PgR positive and HER2-negative
  • Time from last breast cancer surgery and study entry must be no more than 70 days.
  • No evidence of metastatic disease
  • No non-epithelial breast malignancies such as sarcoma or lymphoma.
  • No history of additional invasive breast cancer or DCIS in either breast (LCIS is eligible.)
  • No current invasive breast cancer or DCIS in opposite breast (LCIS is eligible.)
  • No treatment for the currently diagnosed breast cancer prior to study entry (endocrine therapy lasting less than 6 weeks may be acceptable)
  • No history of non-breast cancer (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years
10 years
Pending IRB Approval for Recruiting
Interventional
III
Meribeth Siatta, MSN
331-221-2162
331-221-3889
630-646-6072