drugset / Trial / NCT04852887

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

NCT04852887

Phase 3 Recruiting 1670 enrolled NRG Oncology National Cancer Institute (NCI) · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2021-06-23
Primary completion
2031-04-08
Completion
2041-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Anastrozole Other / unclassified 1 mg
Comparator Exemestane Small molecule 25 mg
Comparator Letrozole Other / unclassified 2.5 mg
Comparator Tamoxifen Small molecule 20 mg