NCT07242118 Conformal Ablative Radiotherapy in Older Women (CARMEN) With Breast Cancer Undergoing Non-Operative Management
| NCT ID | NCT07242118 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Kansas Medical Center |
| Condition | Breast Cancer Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2025-11-04 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 18 participants in total. It began in 2025-11-04 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Morse, MD
PRINCIPAL INVESTIGATOR
University of Kansas Medical Center
Frequently Asked Questions
Who can join the NCT07242118 clinical trial?
This trial is open to female participants only, aged 65 Years or older, studying Breast Cancer Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07242118 currently recruiting?
Yes, NCT07242118 is actively recruiting participants. Contact the research team at aschroeder3@kumc.edu for enrollment information.
Where is the NCT07242118 trial being conducted?
This trial is being conducted at Kansas City, United States, Kansas City, United States.
Who is sponsoring the NCT07242118 clinical trial?
NCT07242118 is sponsored by University of Kansas Medical Center. The principal investigator is Morse, MD at University of Kansas Medical Center. The trial plans to enroll 18 participants.
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