Actively Recruiting
EMERALD: Endocrine Therapy oMission With Radiation in ER+ Breast Cancer: Assessing Quality of Life and Disease Control: a Prospective Phase II Trial
Led by M.D. Anderson Cancer Center · Updated on 2025-10-30
300
Participants Needed
1
Research Sites
284 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
EMERALD: Endocrine Therapy oMission With Radiation in ER+ Breast Cancer: Assessing Quality of Life and Disease Control: a Prospective Phase II Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of pathologically-confirmed invasive breast cancer
- Age 60 years or older
- Treatment with breast conserving surgery (lumpectomy)
- Tumor size 3cm or smaller including any DCIS component
- Ki-67 . 20% and/or Oncotype 0-10 (Ultra Low)
- Final surgical margins negative (no tumor on ink)
- Tumor is estrogen receptor positive, progesterone receptor positive, and HER2 non-amplified
- Clinical nodal stage cN0
- If pathologic nodal staging is done, must be pN0 or pN0(i+)
- Discussion with breast medical oncologist regarding adjuvant treatment options
- Patients who never start endocrine therapy or discontinue it within 6 months after initiation
- Patients treated as luminal A breast cancer if biomarker evaluation is not feasible and documented by PI/protocol collaborators
You will not qualify if you...
- Node positive disease (N1-3)
- Metastatic disease (M1)
- Grade 3 disease and lymphovascular space invasion in the tumor
- Synchronous bilateral breast cancer
- Receipt of neoadjuvant therapy
- Collagen vascular disease associated with increased radiation toxicities (e.g., scleroderma, systemic lupus erythematosus)
- Other cancer diagnosis within prior 5 years except treated basal or squamous cell carcinoma of skin
- Psychiatric illness or social situations limiting study compliance
- Prior radiotherapy to the index breast or recurrent breast cancer
- Known carrier of breast cancer predisposition mutations including BRCA1 or BRCA2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Simona Shaitelman, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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