Study on Hypofractionated Radiotherapy Before or After Breast Surgery for Non-Metastatic Breast Cancer

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06635980

Provider View

This clinical trial is exploring whether giving a specific type of radiation therapy, either before or after breast surgery, can effectively treat patients with non-metastatic breast cancer. The study aims to understand the outcomes and side effects of this treatment approach.

Patient Parameters

Program Overview

The purpose of this study is to see how well a type of radiation therapy called hypofractionated radiotherapy works when given before or after breast surgery in patients with non-metastatic breast cancer. This type of radiation treatment involves giving larger doses over fewer sessions, which may reduce treatment time and side effects. The study will also look at how this approach affects the cancer and the patient's recovery, including cosmetic results and potential complications.

Description

The main goal of this study is to compare the side effects of radiation therapy given before and after breast surgery over the first two years. Researchers will also look at wound healing, infection rates, and how well the cancer is controlled in different groups of patients. They will evaluate how the cancer responds to treatment and track patient-reported outcomes, such as quality of life and cosmetic results.

The study will also explore changes in the cancer's genetic makeup and immune response before and after treatment. Researchers will assess the success rate of breast implants or tissue expanders after radiation and surgery.

Participants will be randomly assigned to one of two groups:

  • Group 1: Patients will receive standard chemotherapy, followed by hypofractionated radiotherapy, and then breast surgery. They will undergo various imaging tests and may provide blood and tissue samples for research.

  • Group 2: Patients will receive standard chemotherapy and breast surgery, followed by hypofractionated radiotherapy. They will also undergo imaging tests and may provide blood and tissue samples.

After completing the treatment, patients will have follow-up visits at 16 weeks, 6 months, 12 months, 24 months, 36 months, and 5 years to monitor their health and the treatment's effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of breast cancer.
  • Cancer stage between T1-T4 N0-3 M0, meaning it has not spread beyond the breast and nearby lymph nodes.
  • Be in good overall health with an ECOG performance status of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Able to provide informed consent and complete all required tests.
  • Willing to return for follow-up visits during the study.
  • Have a medical need for radiation therapy as part of breast cancer treatment.

Exclusion Criteria

  • Medical reasons that prevent receiving radiation therapy.
  • Severe health conditions that could interfere with the study or make participation unsafe.
  • Uncontrolled illnesses, such as active infections or heart problems, that could affect participation.
  • Autoimmune diseases like lupus or scleroderma.
  • Pregnancy or unwillingness to use contraception if of childbearing potential.
  • Previous radiation treatment to the same breast or chest area.
  • Recurrent breast cancer.

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