Non-metastatic Invasive Breast Cancer Clinical Trial
Official title:
Concurrent Capecitabine and Radiotherapy in the Adjuvant Treatment of Resistant Breast Cancer: A Prospective Feasibility Trial
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. ;