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

Launched by M.D. ANDERSON CANCER CENTER · Mar 25, 2025

Keywords

ClinConnect Summary

The EMERALD clinical trial is studying how effective radiotherapy is when given alone to women aged 60 and older who have early-stage, low-risk breast cancer after they have undergone breast-conserving surgery, which is also known as a lumpectomy. The researchers want to find out how this treatment affects patients' quality of life and helps control the disease. To participate in the trial, women must have a specific type of breast cancer that is confirmed by a doctor, be 60 years or older, and have certain characteristics of their tumors, such as being small and having specific hormone receptor statuses.

If you or someone you know is interested in participating, it’s important to know that there are certain criteria that must be met. Eligible participants should not have any signs of cancer spread to nearby lymph nodes or other parts of the body, and their tumors must be of a specific type and size. The trial is not currently recruiting participants, but it aims to provide valuable information on how this treatment impacts health and well-being. Participants can expect to be carefully monitored throughout the study to track their health and response to the treatment.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnosis of pathologically-confirmed invasive breast cancer
• • 2. Age ≥ 60 years
• • 3. Treatment with breast conserving surgery
• • 4. Pathologic T stage of T1 or T2 with total tumor size ≤ 3cm including any component of DCIS that may exist in conjunction with invasive disease
• • 5. Ki-67 ≤ 20%
• • 6. Final surgical margins negative, defined as no tumor on ink. Lobular carcinoma in situ involving the final surgical margin will be disregarded.
• • 7. Tumor must be estrogen receptor positive, progesterone receptor positive and HER2Neu non-amplified as per current College of American Pathologists guidelines
• • 8. Clinical nodal stage cN0
• • 9. If pathologic nodal staging is obtained, then pN0 or pN0(i+)
• • 10. Patients have had or have a scheduled discussion with a breast medical oncologist regarding adjuvant treatment options
• Exclusion Criteria:
• • 1. Node positive disease (N1-3)
• • 2. Metastatic disease (M1)
• • 3. Grade 3 disease and lymphovascular space invasion in the tumor
• • 4. Synchronous bilateral breast cancer
• • 5. Receipt of neoadjuvant therapy
• • 6. Diagnosis of a collagen vascular disease associated with an increased incidence of radiation toxicities such as scleroderma or systemic lupus erythematosis
• • 7. Diagnosis of other cancer within the prior 5 years, excluding basal or squamous cell carcinoma of the skin that has been treated
• • 8. Patient with psychiatric illness/social situations that would limit compliance with study requirements
• • 9. Prior radiotherapy to the index breast or recurrent cancer of the breast
• • 10. Known carrier of a mutation associated with predisposition to breast cancer development, including BRCA1 or BRCA2