This clinical trial tests the effect of local therapy with stereotactic ablative body radiotherapy (SABR) in treating older women with estrogen receptor (ER) positive, HER2 negative invasive breast cancer not undergoing surgery. Standard therapy usually includes endocrine therapy, however, endocrine therapy (ET) alone may likely slow the growth and spread of the tumor for a limited time. SABR is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Giving local therapy with SABR may further limit the tumor from growing and may improve symptoms caused by the tumor in older women with ER positive, HER2 negative invasive breast cancer who are not undergoing surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07242118.
Locations matching your search criteria
United States
Kansas
Kansas City
University of Kansas Cancer CenterStatus: Active
Contact: Ryan T Morse
Phone: 913-588-3600
PRIMARY OBJECTIVE:
I. To estimate the change in the score from baseline to 1-month post-SABR on the BREAST-Q: Physical Well-Being Chest Module in older women receiving non-operative management with SABR for localized breast cancer.
SECONDARY OBJECTIVES:
I. To estimate the change in the score from baseline to 1-month, 6-, and 12-months post-SABR in older women with localized breast cancer undergoing non-operative management using the following BREAST-Q Modules: Satisfaction With Breasts, Adverse Effects of Radiation, Cancer Worry, and Physical-Well Being Chest.
II. To capture patient perception about treatment with SABR using the three-item survey “Was it worth it?” (WIWI).
III. To describe treatment-related toxicity at 1-month, 6-, and 12-months post-SABR using Common Terminology Criteria for Adverse Events (CTCAE) in older women with localized breast cancer undergoing non-operative management.
IV. To estimate 1-year progression-free survival (PFS) and overall survival (OS) amongst older women undergoing non-operative management after receiving SABR.
EXPLORATORY OBJECTIVE:
I. To estimate 2-year and 5-year PFS and OS amongst older women undergoing non-operative management after receiving SABR.
OUTLINE:
Patients undergo either SABR with intensity-modulated radiation therapy (IMRT) or three dimensional conformal radiation therapy (3D CRT) every other day (excluding weekends) for up to 5 fractions in the absence of disease progression or unacceptable toxicity. Patients may also undergo mammography, ultrasound, computed tomography (CT), magnetic resonance imaging (MRI) and/or positron emission tomography (PET)/CT throughout the study.
After completion of study treatment, patients are followed up at 1, 6, and 12 months and at 2 and 5 years.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUniversity of Kansas Cancer Center
Principal InvestigatorRyan T Morse
