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Phase 2Recruiting

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

Sponsored by Mayo Clinic

About this study

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.

PRIMARY OBJECTIVE: I. Compare the baseline-adjusted rate of grade (G)3 or higher radiation treatment related adverse events with the use of preoperative and postoperative radiation within the first 2-years for groups A-D. CORRELATIVE AND EXPLORATORY OBJECTIVES: I. To estimate the rate of grade 3 wound complications and seroma infection between preop and postoperative radiation. II. Group A-D: Determine locoregional control with the use of preoperative radiation conformal radiation. III. Group D \& E: Estimate locoregional control among HER 2+ patients with or without surgery at 2-years. IV. Group E: To determine the rates of surgery for locoregional disease after radiation therapy (RT) at 2 and 5 years. V. To evaluate radiographic complete response and near complete response by magn…

Where this study is enrolling

Who can participate

Inclusion criteria

  • ✓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
  • ✓Able to and provides Institutional Review Board (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 the active monitoring phase of the study)
  • ✓Indications for radiotherapy for breast cancer

Exclusion criteria

  • ✕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
  • ✕Pregnancy
  • ✕Women of childbearing potential who are unwilling to employ adequate contraception
  • ✕Prior receipt of ipsilateral breast or chest wall radiation
  • ✕Recurrent breast cancer

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.