Actively Recruiting
Evaluating Hormone Therapy Omission in Postmenopausal Women 60 with Low-Risk Early Hormone Receptor Positive Breast Cancer
Led by UNICANCER · Updated on 2026-07-17
700
Participants Needed
41
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This trial investigates whether postmenopausal women aged 60 and older with early-stage, low-risk hormone receptor-positive breast cancer can safely avoid hormone therapy after surgery without increasing the risk of cancer relapse. The study focuses on women with small, low-grade tumors classified as Luminal A subtype, which generally have an excellent prognosis and low recurrence rates. Researchers aim to better understand the balance of treatment benefits and side effects, especially considering the long-term burden of hormone therapy on quality of life. Participants will not receive the standard hormone therapy such as tamoxifen or aromatase inhibitors during the study. All participants will have undergone surgery and possibly radiation therapy prior to enrollment. This study enrolls participants for two years and compares their outcomes to historical data from patients who received hormone therapy, assessing cancer recurrence and health outcomes over time. During the trial, participants will be monitored for up to five years after the last enrollment to track relapse-free survival, incidence of new breast cancer events, distant disease-free survival, overall survival, and quality of life. Evaluations will include questionnaires on quality of life, anxiety, and depression, as well as monitoring for bone health, cardiovascular events, and other treatment-related conditions. The study aims to provide evidence for more personalized treatment approaches and to improve shared decision-making for women with low-risk breast cancer.
CONDITIONS
Brief Title
Skipping Hormone Therapy in Low-Risk Early Breast Cancer
Research Team
U
Unicancer Project Leader
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