NCT06635980 · Mayo Clinic
Hypofractionated Radiotherapy Before or After Breast Surgery for Treatment of Patients With Non-Metastatic Breast Cancer
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Biopsy of Breast
Undergo breast biopsy
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
PROCEDURE
Breast Surgery
Undergo breast surgery
DRUG
Chemotherapy
Receive SOC chemotherapy
PROCEDURE
Computed Tomography
Undergo CT
PROCEDURE
Contrast Enhanced Digital Mammography
Undergo CEDM
RADIATION
Hypofractionated Radiation Therapy
Undergo hypofractionated radiotherapy
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
PROCEDURE
Positron Emission Tomography
Undergo PET
OTHER
Survey Administration
Ancillary studies
PROCEDURE
Tissue Collection
Undergo tissue collection
PROCEDURE
Ultrasound Imaging
Undergo ultrasound
Primary outcome measures
Incidence of grade 3 or higher radiation treatment (RT) related adverse events
Time frame: From baseline to 2 years after treatment initiation
Will compare grade 3 or higher RT related adverse events with the use of preoperative and postoperative (Arm 1 versus Arm 2) radiation. Will be defined as an increase in the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 to grade 3+ compared to pre-radiation therapy. The primary analysis will be to estimate the adverse event rate within 2 years, defined as the cumulative incidence of patients experiencing the previously defined adverse events at any time from start of RT over the number of patients that have started RT at 2 years from the start of radiation therapy.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Women of childbearing potential who are unwilling to employ adequate contraception
- Prior receipt of ipsilateral breast or chest wall radiation
- Recurrent breast cancer
Where
- Scottsdale, Arizona
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 12, 2025 · Source of record for eligibility and locations