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

NCT07242118 | Recruiting DMC FDA Device

• 1 other identifier: IIT-2025-CARMEN
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Breast Cancer Female

Keywords

Geriatric; ER-positive; HER2-negative

Outcome Measures

Primary Outcomes (1)

• 1-month post-SABR Physical Well-Being

  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.

  1 month

Secondary Outcomes (4)

• Patient Reported Outcome

  12 months

• Treatment Perception

  12 months

• Incidence of SABR-Related Adverse Events [Safety and Tolerability]

  12 months

• Estimation of Short-term Survival Outcomes

  1 year

Other Outcomes (1)

• Exploratory Objective-Estimation of Long-term Survival Outcomes

  2- and 5-years

Study Arms (1)

SABR Intervention Without Surgery (Single Arm Only)

EXPERIMENTAL

Radiotherapy will be conducted in 5 fractions, every other day. The radiation dose used in this study will use a standard of care post-operative dose of 600 cGy per fraction at 5 total fractions delivered to the clinical target volume. However, since patients in this study will have gross disease and will not have received surgery, a higher dose will be given to the primary tumor itself. Study participants may not receive chemotherapeutic agents after enrollment, unless indicated for disease progression. Patients will be allowed to receive CKD 4/6 inhibitors. Patients will be allowed on this study whether they do or do not receive anti-hormonal therapy. If a patient has not started endocrine therapy before SABR, ideally, they would initiate endocrine therapy after undergoing SABR. If a patient has already started endocrine therapy before SABR, they may continue during the time of SABR at the discretion of the treating physician, as this is considered safe in this setting.

Radiation: SABR

Interventions

SABR RADIATION

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.

SABR Intervention Without Surgery (Single Arm Only)

Eligibility Criteria

• Age: 65 Years+
• Gender Eligibility Details: Assigned female at birth
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (2)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

NOT YET RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Study Officials

• Morse, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Project Manager

CONTACT

913-588-1617; aschroeder3@kumc.edu

Rachel Clinical Research Coordinator

CONTACT

913-945-6955; rheueisen@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Study of women with localized ER+ and HER2- breast cancer receiving non-operative management with SABR delivered to the primary tumor.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 21, 2025
• Study Start: November 4, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)