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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMayo Clinic

About this trial

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 criteria

Qualifiers

Age >= 18 years

Histological confirmation of breast cancer

Clinical stage T1-T4 N0-3 M0

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2

Disqualifiers

Medical contraindication to receipt of radiotherapy

Severe active co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or providing informed consent in the judgment of the principal investigator

Active systemic lupus or scleroderma

Trial design

Treatments tested in this trial

  • Biopsy of Breast
  • Biospecimen Collection
  • Breast Surgery
  • Chemotherapy
  • Computed Tomography
  • Contrast Enhanced Digital Mammography
  • Hypofractionated Radiation Therapy
  • Magnetic Resonance Imaging
  • Positron Emission Tomography
  • Survey Administration
  • Tissue Collection
  • Ultrasound Imaging

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators