Testing the usual treatment of radiation therapy and hormonal therapy to hormonal therapy alone for low-risk, early stage breast cancer
Active Date:
October 19, 2021
IRB Number:
DEBRA BR-007
Condition/Disease:
Breast Cancer
Lead Researcher:
Sania Raza, MD
Location:
Edward Cancer Center - Naperville
Edward Cancer Center - Plainfield
Nancy Knowles Cancer Center - Elmhurst
Purpose:
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
Eligibility:
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
Time Commitment:
10 years
Status:
Accepting Participants
Current Trial Type:
Interventional
Phase:
III
Contact Name:
Meribeth Siatta, MSN
Phone:
331-221-2162
Fax:
331-221-3889
Alternate Phone:
630-646-6072