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Anatomic Stage I Breast Cancer AJCC v8CancerWomen's healthProcedureDrugRadiationPhase 2

What this study is

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.

What's being tested

  • Biopsy of Breast

    Intervention · PROCEDURE

    Undergo breast biopsy

  • Biospecimen Collection

    Intervention · PROCEDURE

    Undergo blood sample collection

  • Breast Surgery

    Intervention · PROCEDURE

    Undergo breast surgery

  • Chemotherapy

    Intervention · DRUG

    Receive SOC chemotherapy

  • Computed Tomography

    Intervention · PROCEDURE

    Undergo CT

  • Contrast Enhanced Digital Mammography

    Intervention · PROCEDURE

    Undergo CEDM

  • Hypofractionated Radiation Therapy

    Intervention · RADIATION

    Undergo hypofractionated radiotherapy

  • Magnetic Resonance Imaging

    Intervention · PROCEDURE

    Undergo MRI

  • Positron Emission Tomography

    Intervention · PROCEDURE

    Undergo PET

  • Survey Administration

    Intervention · OTHER

    Ancillary studies

  • Tissue Collection

    Intervention · PROCEDURE

    Undergo tissue collection

  • Ultrasound Imaging

    Intervention · PROCEDURE

    Undergo ultrasound

Study details

Official title
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
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
Enrolling
120 people
Starts
2025-05-14
Est. completion
2034-10-21
Design
Open-label, randomized, parallel groups, Phase 2
Record
View on ClinicalTrials.gov ↗