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SABR for Breast Cancer in Older Women

This study is looking at a type of radiation therapy called SABR (Stereotactic Ablative Body Radiotherapy) for women aged 65 and older with breast cancer that is ER-positive and HER2-negative. This treatment is being explored as an option instead of surgery. You might be able to join if your breast cancer is 5 cm or smaller and has not spread to your lymph nodes, even if you've had hormone therapy or chemotherapy before. The study will involve 5 SABR treatments, and researchers will check your physical well-being one month after treatment. The study aims to enroll 18 participants, but its current recruitment status is unclear.

Study design
This is a Phase II interventional study, meaning it tests a specific treatment in a small group of people. It plans to enroll 18 women.
What's involved
You will receive 5 SABR treatments. After treatment, you will have follow-up appointments to assess your quality of life and any side effects.
Compensation
Not stated in the trial record.
Follow-up
Your physical well-being will be measured one month after SABR treatment.

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NCT07242118

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

Recruiting
NAAges 65+InterventionalTreatment
University of Kansas Medical Center
~18 participants
Updated 2026-02-10 on ClinicalTrials.gov
What's tested:SABR

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
1-month post-SABR Physical Well-Being
Measured over 1 month

Conditions

Breast Cancer Female

Explore related trials

Breast Carcinoma

Where it's being run

2 sites across 1 states
Kansas2

Study leadership

  • Morse, MD · PRINCIPAL_INVESTIGATOR · University of Kansas Medical Center

Who to contact

Amanda Project Manager
[email protected]
913-588-1617
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Willing and able to provide written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
Women greater than or equal to age 65 years
Diagnosis of invasive carcinoma of breast undergoing non-operative management
Previously untreated OR previously treated with primary ET or chemotherapy, with either stable or progressive localized disease.
Tumor measuring ≤5 cm (cT1-T2) and clinically node negative
Diagnostic biopsy ER-positive (greater than or equal to 10% ER by immunohistochemistry staining)
Diagnostic biopsy HER2-negative according to ASCO/CAP guidelines (0 or 1+ following IHC staining or proven negative by in-situ hybridization)
Suitable for SABR as deemed by the treating radiation oncologist
Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Enrollment in another clinical trial is allowed if there would be no interference with interventions on this trial

Exclusion

Active treatment with systemic chemotherapy for breast cancer. Subjects will need to stop any breast cancer chemotherapy agent before enrollment to be included study.
Multicentric tumor.
Clinical or imaging evidence of distant metastases.
Prior ipsilateral breast or thoracic radiation.
Autoimmune conditions with associated radiation risks.

What this trial measures

  • 1-month post-SABR Physical Well-Being1 month

    To estimate the change in the score from baseline to 1-month post-SABR on the BREAST-Q: Physical Well-Being Chest Module in older women receiving non-operative management with SABR for localized breast cancer. Conversion Table will be used to convert the raw scale summed score into a score from 0 (worst) to 100 (best). Higher scores reflect a better outcome.