Status:
RECRUITING
EMERALD: Endocrine Therapy oMission With Radiation in ER+ Breast Cancer: Assessing Quality of Life and Disease Control: a Prospective Phase II Trial
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
60+ years
Phase:
PHASE2
Brief 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.
Detailed Description
Primary Objective: To determine the 3- year DMFS rate of radiotherapy as adjuvant monotherapy for early stage, low risk breast cancers in patients aged ≥ 60 years Secondary Objectives: 1. To determ...
Eligibility Criteria
Inclusion
- Diagnosis of pathologically-confirmed invasive breast cancer
- Age ≥ 60 years
- Treatment with breast conserving surgery
- 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
- Ki-67 . 20% and/or Oncotype 0-10 (Ultra Low)
- Final surgical margins negative, defined as no tumor on ink. Lobular carcinoma in situ involving the final surgical margin will be disregarded.
- Tumor must be estrogen receptor positive, progesterone receptor positive and HER2Neu non-amplified as per current College of American Pathologists guidelines
- Clinical nodal stage cN0
- If pathologic nodal staging is obtained, then pN0 or pN0(i+)
- Patients have had or have a scheduled discussion with a breast medical oncologist regarding adjuvant treatment options
- Patients who have met criteria 4.1.1-4.1.9 who never initiate endocrine therapy OR who initiate adjuvant endocrine therapy but discontinue it within 6 months of initiation \* In some clinical scenarios, patients may have a particularly small volume of tumor, making it not be feasible for all of these biomarkers to be evaluated. In this scenario, if the PI and/or Protocol Collaborators are able to document that a patient is being treated as if they have luminal A (biologically favorable) breast cancer then the patient is eligible for enrollment if all other eligibility criteria are met.
Exclusion
- 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
- Diagnosis of a collagen vascular disease associated with an increased incidence of radiation toxicities such as scleroderma or systemic lupus erythematosis
- Diagnosis of other cancer within the prior 5 years, excluding basal or squamous cell carcinoma of the skin that has been treated
- Patient with psychiatric illness/social situations that would limit compliance with study requirements
- Prior radiotherapy to the index breast or recurrent cancer of the breast
- Known carrier of a mutation associated with predisposition to breast cancer development, including BRCA1 or BRCA2
Key Trial Info
Start Date :
July 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06897488
Start Date
July 17 2025
End Date
December 31 2030
Last Update
October 30 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030