This is a single-arm, prospective, non-randomized, feasibility study evaluating concurrent capecitabine-radiotherapy in participants with Resistant Breast Cancer.
Primary Objective: \- To evaluate the feasibility of a novel concurrent capecitabine-radiotherapy regimen by characterizing the percentage of patients who complete concurrent capecitabine-radiotherapy as a preliminary study before a larger trial. Secondary Objectives * To report the tolerability of concurrent capecitabine-radiotherapy with patient-reported HRQOL outcomes via RAND 36-Item Health Survey. * To characterize radiation dermatitis secondary to concurrent capecitabine-radiotherapy through patient-reported RISR scores and to compare concurrent RISR scores to published reports of patients undergoing breast cancer radiotherapy only. * To provide a preliminary description of the toxicity profile of concurrent capecitabine radiotherapy and report the frequency of grade 3 or grade 4 toxicity during combined therapy. * To report the feasibility of completion of all study assessments, and completion of all study and exploratory assessments. Outline: This trial will investigate chemoradiotherapy with capecitabine at 1000 mg/m2 BID every other week during radiotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
1,000 mg/m2 twice daily taken by mouth every other week
Once daily (Monday through Friday) for six weeks
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Percentage of patients who complete concurrent capecitabine-radiotherapy
Time frame: Up to 6 months
Assess tolerability
Patient reported health-related quality of life outcomes via RAND 36-Item Health Survey HRQOL outcomes via RAND 36-Item Health Survey
Time frame: Up to 6 months
Characterize radiation dermatitis secondary to concurrent capecitabine-radiotherapy
Through patient-reported RISR scores
Time frame: Up to 7 months
Frequency of grade 3-4 adverse events
Events will be graded according to the National Cancer Institute Common Terminology
Time frame: Up to 7 months
Completion of study study assessments
Median number of study assessments completed
Time frame: Up to 7 months
Completion of exploratory assessments
Median number of exploratory assessment completed
Time frame: Up to 7 months
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