Breast Cancer Female
Conditions
Keywords
Geriatric, ER-positive, HER2-negative
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.
Detailed description
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.
Interventions
RADIATIONSABR
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.
Sponsors
University of Kansas Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Study of women with localized ER+ and HER2- breast cancer receiving non-operative management with SABR delivered to the primary tumor.
Eligibility
Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-month post-SABR Physical Well-Being | 1 month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcome | 12 months | 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. |
| Treatment Perception | 12 months | 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. |
| Incidence of SABR-Related Adverse Events [Safety and Tolerability] | 12 months | 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. |
| Estimation of Short-term Survival Outcomes | 1 year | 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. |
Countries
United States
Contacts
CONTACTAmanda Project Manager
CONTACTRachel Clinical Research Coordinator
PRINCIPAL_INVESTIGATORMorse, MD
University of Kansas Medical Center
Outcome results
None listed