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

NCT06897488 | Recruiting Phase 2 DMC

• 2 other identifiers: 2025-0191NCI-2025-02147
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events

  Through study completion; an average of 1 year

Study Arms (1)

Endocrine Therapy

EXPERIMENTAL

Radiation: Adjuvant Radiotherapy

Interventions

Adjuvant Radiotherapy RADIATION

Participants will receive treatment following Lumpectomy

Endocrine Therapy

Eligibility Criteria

• Age: 60 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Radiotherapy

Study Officials

• Simona Shatelman, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simona Shaitelman, MD

CONTACT

(713) 563-8491; sfshaitelman@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: March 27, 2025
• Study Start: July 17, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 30, 2025

Record last verified: 2025-10

Locations

US (1)