RecruitingPhase 2NCT06897488

EMERALD: Endocrine Therapy oMission With Radiation in ER+ Breast Cancer: Assessing Quality of Life and Disease Control: a Prospective Phase II Trial


Sponsor

M.D. Anderson Cancer Center

Enrollment

300 participants

Start Date

Jul 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical research study is to learn about the effects of giving radiotherapy alone after lumpectomy to patients who have early-stage, low-risk breast cancers and who are 60 years of age or older.


Eligibility

Sex: FEMALEMin Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether women aged 60 and older with early-stage, low-risk, hormone receptor-positive breast cancer who undergo breast-conserving surgery can safely skip hormone therapy (endocrine therapy) and still do well with radiation therapy alone. Endocrine therapy (such as tamoxifen or aromatase inhibitors) has side effects that significantly affect quality of life, and this study aims to determine whether it can be safely omitted in this very low-risk group. **You may be eligible if...** - You are 60 years or older - You have had breast-conserving surgery (lumpectomy) for invasive breast cancer - Your tumor is small (T1 or T2, total size 3 cm or less) - Your cancer is hormone receptor-positive (ER+, PR+) and HER2-negative - Your tumor has very low proliferation markers (Ki-67 under 20% and/or ultra-low Oncotype score 0–10) - Your surgical margins are clear of cancer - You either choose not to start hormone therapy or stopped it within 6 months of starting **You may NOT be eligible if...** - Your cancer is HER2-positive or hormone receptor-negative - You have lymph node involvement (other than tiny microscopic deposits) - Your surgical margins have cancer at the edges - You have already completed hormone therapy as planned Talk to your doctor to see if this trial is right for you.

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.

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Interventions

RADIATIONAdjuvant Radiotherapy

Participants will receive treatment following Lumpectomy


Locations(1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

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NCT06897488


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