Breast CancerPhase 2NCT06897488
EMERALD: Endocrine Therapy oMission With Radiation in ER+ Breast Cancer: Assessing Quality of Life and Disease Control: a Prospective Phase II Trial
A Phase 2 study testing Adjuvant Radiotherapy in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Adjuvant Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2025to 31 Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Simona Shaitelman, MD, 713-563-8491, sfshaitelman@mdanderson.org
Simona Shaitelman, MD
About this study
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.
Read the 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:
- 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
- Conditions
- Breast Cancer
- Being tested
- Adjuvant Radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant RadiotherapyRadiation
Participants will receive treatment following Lumpectomy
| Study group | Role | What they receive |
|---|---|---|
| Endocrine Therapy | Experimental | Not described Receives: Radiation: Adjuvant Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start17 Jul 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simona Shatelman, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897488
- Sponsor's protocol ID
- 2025-0191
- Other IDs
- NCI-2025-02147
- Status last verified
- May 2026
- First submitted
- 25 Mar 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMERALD: Endocrine Therapy oMission With Radiation in ER+ Breast Cancer: Assessing Quality of Life and Disease Control: a Prospective Phase II Trial
- ClinicalTrials.gov ID
- NCT06897488
- Acronym / sponsor ID
- 2025-0191
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 17 Jul 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endocrine Therapy | Experimental | Radiation: Adjuvant Radiotherapy |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjuvant RadiotherapyParticipants will receive treatment following Lumpectomy | Radiation | Endocrine Therapy |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simona Shatelman, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adjuvant Radiotherapy in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simona Shaitelman, MD ((713) 563-8491, sfshaitelman@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.