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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age65+
SponsorUniversity of Kansas Medical Center

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • SABR

Treatment groups

18 Participants
are divided into 1 treatment group