Conformal ablative radiotherapy for older women with localized ER-positive, HER2-negative breast cancer choosing non-surgical care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Kansas Medical Center
  Kansas City, Kansas, United States Recruiting
• University of Kansas Medical Center
  Kansas City, Kansas, United States Not yet 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.