This phase II trial tests how well accelerated partial breast irradiation (APBI) delivered once per day works in ensuring an acceptable breast appearance in patients with low risk, hormone responsive breast cancer. APBI uses precise radiation beams to kill cancerous cells in a smaller area of the breast (partial breast) instead of the whole breast or chest area as in standard therapy. Additionally, APBI is given in a shorter course of treatment than whole breast radiation therapy, over fewer days instead of several weeks, with a lower total dose of radiation. APBI is currently given every other business day for a total of 5 treatments with excellent results; however, a shorter treatment duration could have similar or even better results. Undergoing APBI every day on consecutive business days for 5 treatments may result in an improved breast appearance for patients with low risk hormone responsive breast cancer.
PRIMARY OBJECTIVES: I. To establish that APBI delivered once per day (APBI QD) for low-risk breast cancer patients results in acceptable patient-reported cosmetic appearance of the breast at 1 year after completion of APBI QD. SECONDARY OBJECTIVES: I. To determine the long-term patient-reported cosmetic appearance of the breast in patients treated with APBI QD. II. To determine the short-term and long-term physician reported cosmetic appearance of the breast in patients treated with APBI QD. III. To determine the acute and late patient-reported radiation toxicity of APBI QD. IV. To determine the acute and late physician-reported radiation toxicity of APBI QD. V. To determine the cancer control outcomes of APBI QD. EXPLORATORY OBJECTIVES: I. To assess the health-related quality of life in patients treated with APBI QD. II. To determine the long-term blinded physician review of cosmetic appearance of the breast in patients treated with APBI. III. To assess dosimetric parameters associated with cosmesis in patients undergoing APBI QD. OUTLINE: Patients undergo APBI QD on consecutive business days for 5 treatments. Patients follow up at 1 month, 6 months, and 1 year post-APBI and then yearly until 5 years post-APBI.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
48
Undergo APBI
City of Hope Medical Center
Duarte, California, United States
Proportion of women that rate the cosmetic appearance of the breast as acceptable ("excellent" or "good")
Measured by the 4-point Global Cosmetic Score (GCS). The exact test will be used to test the hypothesis that the rate of cosmesis is \>= 90% versus the null hypothesis that cosmesis is 74% or lower, at the 5% significance level.
Time frame: At 1 year post accelerated partial breast irradiation once daily (APBI QD)
Cosmetic outcome by the patient post-APBI QD
Measured by the GCS. Will be summarized and the percent and 95% confidence limits of the estimate will be calculated. Will also examine at cosmesis scores over time using analysis of variance (ANOVA).
Time frame: Over time at baseline, day 5, 1 month, 6 months, 1 year, 2 years and 3 years
Cosmetic outcome assessed by the physician post-APBI QD
Measured by the GCS. Will explore also examine change in scores over time using ANOVA. Appropriate graphical methods will be used for visualization. Association between the assessment rating of cosmetic outcome based on photographic image by medical doctor (MD) and blinded reviewers will be calculated at each time point using Pearson's product-moment correlation coefficient.
Time frame: At 1 year
Cosmetic outcome assessed by the physician post-APBI QD
Measured by the GCS. Will explore also examine change in scores over time using ANOVA. Association between the assessment rating of cosmetic outcome based on photographic image by MD and blinded reviewers will be calculated at each time point using Pearson's product-moment correlation coefficient.
Time frame: Over time at baseline, day 5, 1 month, 6 months 1 year, 2 years and 3 years
Incidence of adverse events-patients reported
Scored by the Patient-Reported Outcome Common Terminology Criteria for Adverse Events (CTCAE). Will be summarized using standard methods.
Time frame: Up to 3 years post-APBI
Incidence of adverse events-treatment team reported
As scored by the treatment team using CTCAE version 5.0. Will be summarized using standard methods.
Time frame: Up to 3 years post-APBI
In-breast recurrence
The Kaplan-Meier method will be used along with 95% confidence intervals.
Time frame: Up to 5 years post-APBI QD
Regional recurrence
The Kaplan-Meier method will be used along with 95% confidence intervals.
Time frame: Up to 5 years post-APBI QD
Distant metastases
The Kaplan-Meier method will be used along with 95% confidence intervals.
Time frame: Up to 5 years post-APBI QD
Disease-free survival
The Kaplan-Meier method will be used along with 95% confidence intervals.
Time frame: Up to 5 years post-APBI QD
Overall survival
The Kaplan-Meier method will be used along with 95% confidence intervals.
Time frame: Up to 5 years post-APBI QD
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