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

University of Kansas

Status: Not yet enrolling

Conditions: Breast Cancer Female

Treatments: Radiation: SABR

Study type: Interventional

Funder types: Other

Identifiers

NCT07242118

IIT-2025-CARMEN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 estimated patients

Sex: Female

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

SABR Intervention Without Surgery (Single Arm Only)

Experimental group

Description:

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.

Treatment:

Radiation: SABR