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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.
This is a prospective, phase II study of women with localized breast cancer receiving non-operative management with SABR delivered to the primary tumor. Patients will be screened that are age 65 and over with invasive breast cancer. Those eligible for the trial will have ER-positive and HER2-negative disease measuring ≤5 cm with negative clinical lymph nodes. Patients that were previously on primary ET, with either stable or progressive disease, will be eligible for this study if other inclusion criteria are met. Participants will receive SABR targeting the tumor consisting of 5 total treatments. Participants will then follow-up as per protocol with quality-of-life assessments and treatment-related toxicity evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SABR Intervention Without Surgery (Single Arm Only) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SABR | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 1-month post-SABR Physical Well-Being | 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. Conversion Table will be used to convert the raw scale summed score into a score from 0 (worst) to 100 (best). Higher scores reflect a better outcome. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Outcome | 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. Conversion Table will be used to convert the raw scale summed score into a score from 0 (worst) to 100 (best). Higher scores reflect a better outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Objective-Estimation of Long-term Survival Outcomes | To estimate 2-year and 5-year PFS and OS amongst older women undergoing non-operative management after receiving SABR. Units of Measure include qualitative analysis at 2-years and 5-years post-radiation: 'alive with disease', 'alive without disease', 'deceased with disease', and 'deceased without disease'. | 2- and 5-years |
Inclusion Criteria:
Exclusion Criteria:
Assigned female at birth
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amanda Project Manager | Contact | 913-588-1617 | aschroeder3@kumc.edu | |
| Rachel Clinical Research Coordinator | Contact | 913-945-6955 | rheueisen@kumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Morse, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Not yet recruiting | Kansas City | Kansas | 66160 | United States | |
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Study of women with localized ER+ and HER2- breast cancer receiving non-operative management with SABR delivered to the primary tumor.
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| 12 months |
| Treatment Perception | To capture patient perception about treatment with SABR using the three-item survey "Was it worth it?" (WIWI). Scores will be summed from 3 (lowest) to 9 (highest). Higher scores reflect higher satisfaction. | 12 months |
| Incidence of SABR-Related Adverse Events [Safety and Tolerability] | 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. | 12 months |
| Estimation of Short-term Survival Outcomes | To estimate 1-year progression-free survival (PFS) and overall survival (OS) amongst older women undergoing non-operative management after receiving SABR. Units of Measure include 'alive with disease', 'alive without disease', 'deceased with disease', and 'deceased without disease' at 1-year time interval. | 1 year |
| University of Kansas Medical Center |
| Recruiting |
| Kansas City |
| Kansas |
| 66160 |
| United States |
|