Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT06635980

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

Led by Mayo Clinic · Updated on 2025-12-12

120

Participants Needed

1

Research Sites

492 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age >= 18 years
  • Histological confirmation of breast cancer
  • Clinical stage T1-T4 N0-3 M0
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
  • Able to and provides IRB-approved study specific written informed consent
  • Able to complete all mandatory tests listed in the trial
  • Willing to return to enrolling institution for follow-up during active monitoring phase
  • Indications for radiotherapy for breast cancer
Not Eligible

You will not qualify if you...

  • Medical contraindication to receipt of radiotherapy
  • Severe active co-morbid systemic illnesses or severe concurrent disease making patient inappropriate for study
  • Uncontrolled intercurrent illness such as active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness limiting compliance or consent
  • Active systemic lupus or scleroderma
  • Pregnancy
  • Women of childbearing potential unwilling to use adequate contraception
  • Prior receipt of ipsilateral breast or chest wall radiation
  • Recurrent breast cancer

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Arizona

Scottsdale, Arizona, United States, 85259

Actively Recruiting

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Research Team

C

Clinical Trials Referral Office

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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