Actively Recruiting
Conformal Ablative Radiotherapy in Older Women (CARMEN) With Breast Cancer Undergoing Non-Operative Management
Led by University of Kansas Medical Center · Updated on 2026-02-10
18
Participants Needed
2
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II study evaluates SABR as non-operative treatment for women aged 65+ with ER-positive, HER2-negative breast cancer ≤5 cm and no lymph node involvement. Eligible patients, including those previously on endocrine therapy, receive 5 SABR treatments, followed by monitoring of quality of life and assessment of treatment-related toxicity.
CONDITIONS
Official Title
Conformal Ablative Radiotherapy in Older Women (CARMEN) With Breast Cancer Undergoing Non-Operative Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent and HIPAA authorization
- Women aged 65 years or older
- Diagnosed with invasive breast carcinoma and undergoing non-operative management
- Either untreated or previously treated with primary endocrine therapy or chemotherapy with stable or progressive localized disease
- Tumor size 5 cm or less (cT1-T2) and clinically lymph node negative
- Biopsy confirming estrogen receptor positive (≥10% ER by immunohistochemistry)
- Biopsy confirming HER2 negative according to ASCO/CAP guidelines (0 or 1+ IHC or negative by in-situ hybridization)
- Suitable for stereotactic ablative radiotherapy as determined by radiation oncologist
- Prior or concurrent malignancies allowed if they do not interfere with safety or efficacy assessment
- Enrollment in other clinical trials allowed if no interference with this trial's interventions
You will not qualify if you...
- Currently receiving systemic chemotherapy for breast cancer; chemotherapy must be stopped before enrollment
- Presence of multicentric tumor
- Evidence of distant metastases by clinical or imaging studies
- Prior radiation therapy to the same breast or chest area
- Autoimmune conditions that increase risk from radiation therapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Not Yet Recruiting
2
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
Research Team
A
Amanda Project Manager
CONTACT
R
Rachel Clinical Research Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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