This phase I trial studies how well capecitabine and radiation therapy after surgery work in treating patients with invasive breast cancer that has not spread to other places in the body. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving capecitabine and radiation therapy together may kill more tumor cells in patients with invasive breast cancer compared to capecitabine or radiation therapy alone.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03958721.
PRIMARY OBJECTIVE:
I. 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:
I. To report the tolerability of concurrent capecitabine-radiotherapy with patient-reported health-related quality of life (HRQOL) outcomes via research and development (RAND) 36-Item Health Survey.
II. To characterize radiation dermatitis secondary to concurrent capecitabine-radiotherapy through patient-reported radiation-induced skin reaction (RISR) scores and to compare concurrent RISR scores to published reports of patients undergoing breast cancer radiotherapy only.
III. To provide a preliminary description of the toxicity profile of concurrent capecitabine-radiotherapy and report the frequency of g3 or g4 toxicity during combined therapy.
IV. To report the feasibility of completion of all study assessments, and completion of all study + exploratory assessments.
EXPLORATORY CORRELATIVE STUDY OBJECTIVES:
I. To pilot a novel methodology of quantifying radiation dermatitis as a continuous variable termed “erythema index”.
II. To explore the clinical utility of the erythema index and correlations with clinician-driven determinations of radiation dermatitis and patient-reported outcomes of radiation dermatitis.
III. To report on inter-user variations in body-surface-area deemed affected by dermatitis.
OUTLINE:
Patients receive capecitabine orally (PO) twice daily (BID) every other week and undergo radiation therapy once daily (QD) on Monday-Friday for 6 weeks. After completion of radiation therapy, patients may continue to receive capecitabine PO BID every other week or on days 1-14 at the discretion of the treating physician. Cycles repeats every 3 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 4 weeks, then at 1 and 2 years.
Lead OrganizationVanderbilt University/Ingram Cancer Center
Principal InvestigatorAnuradha Bapsi Chakravarthy
