Conformal Ablative Radiotherapy in Older Women (CARMEN) With Breast Cancer Undergoing Non-Operative Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SABR.
- Who it may be relevant to
- Registry conditions: Breast Cancer Female. Basic parameters: from 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- 1-month post-SABR Physical Well-Being [Time frame: 1 month]
Secondary outcome measures (4)
- Patient Reported Outcome [Time frame: 12 months]
- Treatment Perception [Time frame: 12 months]
- Incidence of SABR-Related Adverse Events [Safety and Tolerability] [Time frame: 12 months]
- Estimation of Short-term Survival Outcomes [Time frame: 1 year]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- University of Kansas Medical Center — Kansas City
- University of Kansas Medical Center — Kansas City
Identifiers
NCT: NCT07242118 · IIT-2025-CARMEN