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)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |