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

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.

Conditions

• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8
• Breast Carcinoma
• Triple-Negative Breast Carcinoma

Interventions

PROCEDURE

Biopsy of Breast

Undergo breast biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Breast Surgery

Undergo breast surgery

DRUG

Chemotherapy

Receive SOC chemotherapy

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Contrast Enhanced Digital Mammography

Undergo CEDM

RADIATION

Hypofractionated Radiation Therapy

Undergo hypofractionated radiotherapy

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Positron Emission Tomography

Undergo PET

OTHER

Survey Administration

Ancillary studies

PROCEDURE

Tissue Collection

Undergo tissue collection

PROCEDURE

Ultrasound Imaging

Undergo ultrasound

Sponsors & Collaborators

• Mayo Clinic

  lead OTHER

Principal Investigators

• Carlos E. Vargas, MD · Mayo Clinic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-14

Primary Completion

2031-10-21

Completion

2034-10-21

Countries

• United States

Study Locations