Hypofractionated Radiotherapy Before or After Breast Surgery for Treatment of Patients With Non-Metastatic Breast Cancer

Study Summary

This phase II trial studies how well hypofractionated radiotherapy before (preoperative) or after (postoperative) breast surgery works in treating patients with different types of non-metastatic (has not spread from original tumor site) breast cancer and to determine the outcomes and side effects of this treatment. Radiation therapy is considered an integral part of breast conserving therapy. Hypofractionated radiation therapy is a radiation treatment in which the total dose of radiation is divided into large doses and treatments are given less than once a day. This has been shown to be an effective treatment for breast cancer while reducing treatment time and decreasing side effects. Preoperative radiotherapy alone or concurrently with chemotherapy has also been tested with excellent results and with minimal toxicity. Preoperative radiation of the intact tumor with a hypofractionated regimen can potentially decrease toxicity by allowing the delivery of treatment to intact breast tissue. The potential advantages of preoperative radiation therapy include the delivery of radiation in the intact breast when radiation can be more effective as more oxygen can be available in the tissue. Furthermore, complications and cosmetic results are expected to be lower in pre-operative radiotherapy before surgery, as there have been no changes in blood supply to the breast. This lends to the possibility of using lower doses of radiotherapy to patients, and potentially better cancer associated clinical outcomes for our breast cancer patients. Undergoing hypofractionated radiation therapy before or after breast surgery may be safe and effective in treating patients with different types of non-metastatic breast cancer.

Primary Outcome

Will assess the occurrence of grade 3 or higher RT related adverse events within years from the start of radiation therapy. Will be defined as an increase in the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 to grade 3+ compared to pre-radiation therapy. Adverse event rate will be defined as the proportion of patients experiencing the previously defined adverse events at any time from start of RT over the number of randomized patients included in the primary analysis populat

Conditions Studied

Interventions

• PROCEDURE Biospecimen Collection
• PROCEDURE Computed Tomography
• PROCEDURE Biopsy of Breast
• PROCEDURE Breast Surgery
• DRUG Chemotherapy

Study Locations (1)