Recruiting
Phase 2

Hypofractionated Radiotherapy

Sponsor:

Mayo Clinic

Code:

NCT06635980

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

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biopsy of Breast

Biospecimen Collection

Breast Surgery

Chemotherapy

Computed Tomography

Study Details

Brief summary:

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.

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

Study ID

NCT06635980

Start date

May 14, 2025

Status verified date

Sep, 2026

Completion date

Oct 21, 2034

Anticipated

Primary completion date

Oct 21, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm I (Preoperative radiation therapy + surgery)

Patients undergo SOC chemotherapy followed by breast hypofractionated radiotherapy QD for a total of 5 fractions. Patients then undergo SOC breast surgery 10 weeks after radiation treatment. Patients also undergo CT, MRI, PET, CEDM, and/or breast US throughout the study. Additionally, patients undergo a breast biopsy and may undergo optional blood sample collection and tissue collection on study.

experimental: Arm II (Surgery + postoperative radiation therapy)

Patients undergo SOC chemotherapy and SOC breast surgery followed by breast hypofractionated radiotherapy QD for a total of 5 fractions. Patients also undergo CT, MRI, PET, CEDM, and/or breast US throughout the study. Additionally, patients undergo a breast biopsy and may undergo optional blood sample collection and tissue collection on study.

Interventions

Biopsy of Breast

Undergo breast biopsy

Biospecimen Collection

Undergo blood sample collection

Breast Surgery

Undergo breast surgery

Chemotherapy

Receive SOC chemotherapy

Computed Tomography

Undergo CT

Contrast Enhanced Digital Mammography

Undergo CEDM

Hypofractionated Radiation Therapy

Undergo hypofractionated radiotherapy

Magnetic Resonance Imaging

Undergo MRI

Positron Emission Tomography

Undergo PET

Survey Administration

Ancillary studies

Tissue Collection

Undergo tissue collection

Ultrasound Imaging

Undergo ultrasound

Primary outcome measure

  • Incidence of grade 3 or higher radiation treatment (RT) related adverse events [ Time Frame: From baseline to 2 years after treatment initiation ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Carlos E. Vargas, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-09-03.