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RecruitingPhase 2

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

A Randomized Phase II Trial of Hypofractionated Radiotherapy for Non-Metastatic Breast Cancer Before or After Breast Surgery for Different Breast Cancer Risk Groups

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans, CT scans, Ultrasound, Blood draws, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "To evaluate radiographic complete response and near complete response by magnetic resonance imaging (MRI) and positron emission tomography (PET)."
  • "Patients also undergo computed tomography (CT), MRI, PET, contrast-enhanced digital mammography (CEDM), and/or breast ultrasound (US) throughout the study."
  • "Additionally, patients undergo a biopsy and may undergo optional blood sample collection and tissue collection on study."
  • "Patients also undergo CT, MRI, PET, CEDM, and/or breast US throughout the study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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

Study sites (1)

AZ