Skipping Hormone Therapy in Low-Risk Early Breast Cancer
No Endocrine Therapy in Small HR⁺/HER2- Low Risk Luminal A Early Breast Cancer, a Single-arm De-escalation Trial
UNICANCER
700 participants
Jul 6, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The standard of care endocrine therapy (Tamoxifene, Letrozole, Anastrozole or Exemestane) will not be received by the participant during the study.
Locations(41)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07661927