Phase 2Recruiting
Skipping Hormone Therapy in Low-Risk Early Breast Cancer (NoELA)
No Endocrine Therapy in Small HR⁺/HER2- Low Risk Luminal A Early Breast Cancer, a Single-arm De-escalation Trial
- Sponsor
- UNICANCER (Academic or other)
- Enrolment
- 700 planned
- Conditions
- Breast Cancer (Early Breast Cancer)
- Interventions
- Removing Endocrine Therapy
- Ages
- adults, older adults
- Registry
- NCT07661927
From the registry
The goal of this clinical trial is to determine whether a selected population of women with early-stage, low-risk breast cancer can avoid hormone therapy without increasing their risk of relapse. It will also evaluate the prognosis of these participants compared to participants who received standard treatment with hormone therapy in another study, estimate the risk of specific recurrence, cardiovascular and bone health, and participants' quality of life. All participants will have undergone surgery and possibly radiation therapy, but unlike standard care, they will not receive hormone therapy afterward. Participants will be enrolled for two years and followed for up to five years after the last participant is enrolled in the trial to monitor for long-term cancer recurrence.
Primary outcomes
- Relapse-free interval