No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
65 and older
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
18 (estimated)
Sponsor
University of Kansas Medical Center · Other
Who this trial is looking for
This trial is looking for women aged 65 and older who have a specific type of breast cancer. Participants will receive five treatments of a targeted radiation therapy and will be monitored for side effects and quality of life.
Are You a Good Fit for This Trial?
Must not be takingBreast cancer chemotherapy
You may be able to join if
I am 65 years old or older
I have been diagnosed with breast cancer
My tumor is 5 cm or smaller
I have not had breast cancer chemotherapy recently
My tumor is ER-positive
My tumor is HER2-negative
I have no evidence of cancer spread to other parts of my body
I can provide written consent to join the study
You may not be able to join if
I am currently receiving systemic chemotherapy for breast cancer
I have a multicentric tumor
I have evidence of distant metastases
I have had prior radiation to my breast or chest area
I have an autoimmune condition that could increase radiation risks
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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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 mana…
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.
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