Conformal ablative radiotherapy for older women with localized ER-positive, HER2-negative breast cancer choosing non-surgical care
Conformal Ablative Radiotherapy in Older Women (CARMEN) With Breast Cancer Undergoing Non-Operative Management
This study will test whether five focused SABR treatments can control ER-positive, HER2-negative breast tumors up to 5 cm in women aged 65 and older who are opting for non-surgical management.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 65 Years and up |
| Sex | Female |
| Sponsor | University of Kansas Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Kansas City, Kansas and 1 other locations) |
| Trial ID | NCT07242118 on ClinicalTrials.gov |
What this trial studies
This is a prospective phase II study enrolling women aged 65 or older with invasive, ER-positive, HER2-negative breast cancer up to 5 cm and clinically node-negative disease. Eligible participants, including those previously treated with endocrine therapy, will receive stereotactic ablative radiotherapy (SABR) delivered to the primary tumor in five treatments. Patients will be followed per protocol with regular assessments of treatment-related toxicity and quality of life. The study aims to measure local control and safety of SABR as a non-operative local treatment option.
Who should consider this trial
Good fit: Women aged 65 or older with invasive ER-positive, HER2-negative breast cancer measuring ≤5 cm, clinically node-negative, and judged suitable for SABR (including those previously on primary endocrine therapy) are ideal candidates.
Not a fit: Patients with ER-negative or HER2-positive tumors, tumors larger than 5 cm, clinically node-positive disease, or those who are not suitable for SABR due to tumor location or medical comorbidities are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could offer an effective non-surgical local treatment that avoids operative risks and recovery for older patients.
How similar studies have performed: Using SABR to treat primary breast tumors is a relatively new approach with limited but growing early-phase and small-series evidence, and it has not yet been widely proven as a standard alternative to surgery.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Kansas City, Kansas and 1 other locations
- University of Kansas Medical Center — Kansas City, Kansas, United States (Not_yet_recruiting)
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
Study contacts
- Principal investigator: Morse, MD — University of Kansas Medical Center
- Study coordinator: Amanda Project Manager
- Email: aschroeder3@kumc.edu
- Phone: 913-588-1617
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.