EMERALD: Endocrine Therapy oMission With Radiation in ER+ Breast Cancer: Assessing Quality of Life and Disease Control: a Prospective Phase II Trial
M.D. Anderson Cancer Center
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.
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, cont…
Eligibility
- Age range
- 60+ years
- Sex
- Female
- Healthy volunteers
- No
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 cur…
Interventions
- RadiationAdjuvant Radiotherapy
Participants will receive treatment following Lumpectomy
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas