RecruitingPhase 2NCT06635980

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

A Randomized Phase II Trial of Hypofractionated Radiotherapy for Non-Metastatic Breast Cancer Before or After Breast Surgery for Different Breast Cancer Risk Groups


Sponsor

Mayo Clinic

Enrollment

120 participants

Start Date

May 14, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a radiation therapy approach called hypofractionation — delivering radiation in fewer but slightly larger doses — for breast cancer patients, given either before or after surgery. Hypofractionation may be more convenient and potentially just as effective as standard longer radiation courses. The study is open to a wide range of breast cancer patients across multiple stages. **You may be eligible if...** - You are 18 or older with a confirmed breast cancer diagnosis - Your cancer is non-metastatic (stages T1–T4, N0–3, M0) - Your doctor has recommended radiation therapy as part of your treatment plan - Your overall health status allows participation (ECOG 0–2) - You are willing to return for follow-up visits **You may NOT be eligible if...** - You have a medical reason you cannot receive radiation therapy - You have uncontrolled serious illness (infection, heart problems, severe psychiatric conditions) - You have lupus or scleroderma (conditions that make radiation riskier) - You are pregnant or not willing to use contraception - You have previously received radiation to the same breast or chest wall - Your breast cancer has come back (recurrent disease) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREBiopsy of Breast

Undergo breast biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBreast Surgery

Undergo breast surgery

DRUGChemotherapy

Receive SOC chemotherapy

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREContrast Enhanced Digital Mammography

Undergo CEDM

RADIATIONHypofractionated Radiation Therapy

Undergo hypofractionated radiotherapy

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREPositron Emission Tomography

Undergo PET

OTHERSurvey Administration

Ancillary studies

PROCEDURETissue Collection

Undergo tissue collection

PROCEDUREUltrasound Imaging

Undergo ultrasound


Locations(1)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06635980


Related Trials