A Phase II Study of Three-Day Partial Breast Radiation Therapy in Women with Breast Cancer

Full Title

Ultra-Short External Beam-Based Accelerated Partial Breast Irradiation (APBI): A Phase II Toxicity Study Nested with a Non-inferiority Assessment of APBI in New Patient Cohorts

Purpose

The purpose of this study is to assess the safety and effectiveness of partial breast radiation therapy given over a three-day period (three weekdays in a row) in women with ductal carcinoma in situ (DCIS) or early-stage invasive breast cancer after lumpectomy. Women who are not in a research study usually receive radiation therapy to the whole breast over three weeks or receive partial breast irradiation over a five- to ten-day period.

The total dose of radiation in this study is calculated to be the same as that used in standard treatment; however, the dose patients receive during each radiation therapy session will be higher because the treatment will be delivered over three days rather than five to ten days. The goal is to see if this “ultra-short” treatment is well-tolerated and effective for preventing the cancer from returning.

Protocol
19-300
Phase
Phase II (phase 2)
Disease Status
Newly Diagnosed
Investigator
Co-Investigators
Diseases
ClinicalTrials.gov ID
NCT04084730