Recruiting

SABR

Sponsor:

University of Kansas Medical Center

Code:

NCT07242118

Conditions

Breast Cancer Female

Eligibility Criteria

Sex: Female

Age: 65+

Healthy Volunteers: Accepted

Interventions

SABR

Study Details

Brief summary:

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.

Conditions

Breast Cancer Female

Study ID

NCT07242118

Start date

Nov 4, 2025

Status verified date

Feb, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 65+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

18 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SABR Intervention Without Surgery (Single Arm Only)

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.

Interventions

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 measure

  • 1-month post-SABR Physical Well-Being [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Amanda Project Manager

913-588-1617aschroeder3@kumc.edu

Rachel Clinical Research Coordinator

913-945-6955rheueisen@kumc.edu

Locations

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Rachel Clinical Research Coordinator

913-588-6249rheueisen@kumc.edu

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Keywords

  • Geriatric
  • ER-positive
  • HER2-negative

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2026-02-10.