NCT07242118

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: Female
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a prospective, phase II study of women with localized breast cancer receiving non-operative management with SABR delivered to the primary tumor. Patients will be screened that are age 65 and over with invasive breast cancer. Those eligible for the trial will have ER-positive and HER2-negative disease measuring ≤5 cm with negative clinical lymph nodes. Patients that were previously on primary ET, with either stable or progressive disease, will be eligible for this study if other inclusion criteria are met. Participants will receive SABR targeting the tumor consisting of 5 total treatments. Participants will then follow-up as per protocol with quality-of-life assessments and treatment-related toxicity evaluation.

Conditions

• Breast Cancer Female

Interventions

Type	Name	Description
RADIATION	SABR	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.

Timeline

• Start date: 2025-11-04
• Primary completion: 2027-09-01
• Completion: 2027-10-01
• First posted: 2025-11-21
• Last updated: 2026-02-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study