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

Last updated: October 28, 2025
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Recruiting

Phase

2

Condition

Breast Cancer

Cancer

Treatment

Adjuvant Radiotherapy

Clinical Study ID

NCT06897488
2025-0191
NCI-2025-02147
  • Ages > 60
  • Female

Study 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 Criteria

Inclusion

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 componentof DCIS that may exist in conjunction with invasive disease

  5. Ki-67 . 20% and/or Oncotype 0-10 (Ultra Low)

  6. Final surgical margins negative, defined as no tumor on ink. Lobular carcinoma insitu involving the final surgical margin will be disregarded.

  7. Tumor must be estrogen receptor positive, progesterone receptor positive and HER2Neunon-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 oncologistregarding adjuvant treatment options

  11. Patients who have met criteria 4.1.1-4.1.9 who never initiate endocrine therapy ORwho initiate adjuvant endocrine therapy but discontinue it within 6 months ofinitiation * In some clinical scenarios, patients may have a particularly smallvolume of tumor, making it not be feasible for all of these biomarkers to beevaluated. In this scenario, if the PI and/or Protocol Collaborators are able todocument that a patient is being treated as if they have luminal A (biologicallyfavorable) breast cancer then the patient is eligible for enrollment if all othereligibility criteria are met.

Exclusion

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 ofradiation toxicities such as scleroderma or systemic lupus erythematosis

  7. Diagnosis of other cancer within the prior 5 years, excluding basal or squamous cellcarcinoma of the skin that has been treated

  8. Patient with psychiatric illness/social situations that would limit compliance withstudy 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 cancerdevelopment, including BRCA1 or BRCA2

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Adjuvant Radiotherapy
Phase: 2
Study Start date:
July 17, 2025
Estimated Completion Date:
December 31, 2030

Study 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 determine the HRQoL of patients ≥ 60 years with early stage, low risk breast cancer receiving adjuvant monotherapy with radiotherapy

  2. 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

  3. 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

  4. To determine the 5-year utilization of salvage mastectomy and other salvage therapies

  5. To determine late (up to 11 year) oncologic outcome data for patients accessible via chart review or phone call

  6. To determine the toxicities experienced by patients ≥ 60 years with early stage, low risk breast cancer receiving adjuvant monotherapy with radiotherapy

Connect with a study center

  • The University of Texas M. D. Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • The University of Texas M. D. Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

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