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