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RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 11 years
  • Procedures mentioned: Phone or video check-ins

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "To determine late (up to 11 year) oncologic outcome data for patients accessible via chart review or phone call 6."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests radiation alone after a lumpectomy, surgery that removes breast cancer but keeps the breast. It is for people age 60 or older with early-stage, low-risk breast cancer. Researchers will look at quality of life and how well the treatment controls cancer without hormone-blocking medicine.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 60 or older, with breast cancer confirmed by a tissue test, and treated with breast-saving surgery.
  • The tumor is stage T1 or T2 and no larger than 3 cm, counting any DCIS (cancer still inside the milk ducts).
  • The tumor has estrogen and progesterone receptors and is HER2-negative. These tests help show how the cancer may grow.
  • The listing requires a Ki-67 growth test result and/or an Oncotype score of 0–10. The Ki-67 cutoff is unclear in the listing; ask the study team. Some very small tumors may qualify without all these tests if study doctors document favorable cancer features.
  • No cancer touches the marked edge of the removed tissue. LCIS, a type of abnormal cell growth in breast glands, at this edge does not count.
  • No signs of cancer in nearby lymph nodes. If nodes are tested, they must have no cancer or only isolated cancer cells.
  • Have had, or have scheduled, a talk with a breast cancer medicine doctor about treatment options after surgery.
  • Never started hormone-blocking medicine after surgery, or stopped it within 6 months of starting.

Who can't join

  • Cancer has spread to nearby lymph nodes beyond isolated cells, or to distant parts of the body.
  • The tumor is grade 3 (fast-growing) and has cancer cells in nearby blood vessels or lymph channels.
  • Cancer in both breasts at the same time.
  • Received cancer treatment before surgery.
  • Have a disease, such as scleroderma or lupus, that raises the risk of harm from radiation.
  • Another cancer was diagnosed in the past 5 years, except treated basal or squamous cell skin cancer.
  • A mental health condition or life situation would make it hard to follow study requirements.
  • Had radiation to the affected breast before, have breast cancer that came back, or carry a known gene change that raises breast cancer risk, such as BRCA1 or BRCA2.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 component of 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 in situ involving the final surgical margin will be disregarded. 7. Tumor must be estrogen receptor positive, progesterone receptor positive and HER2Neu non-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 oncologist regarding adjuvant treatment options 11. 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: 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 of radiation toxicities such as scleroderma or systemic lupus erythematosis 7. Diagnosis of other cancer within the prior 5 years, excluding basal or squamous cell carcinoma of the skin that has been treated 8. Patient with psychiatric illness/social situations that would limit compliance with study 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 cancer development, including BRCA1 or BRCA2

Study sites (1)

TX