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

M.D. Anderson Cancer Center

Status and phase

Enrolling

Phase 2

Conditions

Breast Cancer

Treatments

Radiation: Adjuvant Radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06897488

NCI-2025-02147 (Other Identifier)

2025-0191

Details and patient eligibility

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.

Full 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:

To determine the HRQoL of patients ≥ 60 years with early stage, low risk breast cancer receiving adjuvant monotherapy with radiotherapy
To determine the 3-year and 5-year risk of ipsilateral breast tumor recurrence (IBTR) for early-stage breast cancers treated with lumpectomy and adjuvant radiotherapy without endocrine therapy
To quantify the 3-year and 5-year rates of local-regional recurrence, contralateral breast cancer, breast cancer-specific survival and overall survival and the 5 year rate of DMFS
To determine the 5-year utilization of salvage mastectomy and other salvage therapies
To determine late (up to 11 year) oncologic outcome data for patients accessible via chart review or phone call
To determine the toxicities experienced by patients ≥ 60 years with early stage, low risk breast cancer receiving adjuvant monotherapy with radiotherapy

Enrollment

300 estimated patients

Sex

Female

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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