RecruitingNot ApplicableNCT07242118

Conformal Ablative Radiotherapy in Older Women (CARMEN) With Breast Cancer Undergoing Non-Operative Management

Sponsor

University of Kansas Medical Center

Enrollment

18 participants

Start Date

Nov 4, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Female

Summary

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.

Eligibility

Sex: FEMALEMin Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a specialized form of high-dose targeted radiation (called SABR or SBRT — stereotactic ablative radiotherapy) as an alternative to surgery for older women with breast cancer who are choosing to manage their cancer without an operation. Researchers want to see if this non-surgical approach can effectively control the cancer. **You may be eligible if...** - You are a woman aged 65 or older with confirmed invasive breast cancer - You are choosing to manage your breast cancer without surgery - Your tumor is 5 cm or smaller and lymph nodes appear cancer-free - Your cancer is estrogen receptor positive (ER+, ≥10%) and HER2-negative - Your radiation oncologist has confirmed you are suitable for this type of radiation **You may NOT be eligible if...** - You have inflammatory breast cancer - Your cancer has spread to lymph nodes or elsewhere - You have had prior breast radiation - You have a condition that makes radiation therapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONSABR

Radiation therapy will consist of either IMRT or 3D CRT. The modality chosen will be based on the plan with the preferable dosimetric variables and determined by the treating radiation oncology physician. SABR will be prescribed to a total dose of 35 Gy to the GTV over the course of 5 fractions (7 Gy per fraction), ideally treated every other day (excluding weekends). The CTV will be prescribed 30 Gy over 5 fractions, ideally treated every other day.