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

NCT06635980 | Recruiting Phase 2 DMC

• 3 other identifiers: GMROA2234NCI-2024-0835622-009070
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of grade 3 or higher radiation treatment (RT) related adverse events

  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.

  From baseline to 2 years after treatment initiation

Study Arms (2)

Arm I (Preoperative radiation therapy + surgery)

EXPERIMENTAL

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.

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

Arm II (Surgery + postoperative radiation therapy)

EXPERIMENTAL

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.

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

Interventions

Biopsy of Breast PROCEDURE

Undergo breast biopsy

Also known as: Breast Biopsy

Arm I (Preoperative radiation therapy + surgery); Arm II (Surgery + postoperative radiation therapy)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (Preoperative radiation therapy + surgery); Arm II (Surgery + postoperative radiation therapy)

Breast Surgery PROCEDURE

Undergo breast surgery

Arm I (Preoperative radiation therapy + surgery); Arm II (Surgery + postoperative radiation therapy)

Chemotherapy DRUG

Receive SOC chemotherapy

Also known as: Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General

Arm I (Preoperative radiation therapy + surgery); Arm II (Surgery + postoperative radiation therapy)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Arm I (Preoperative radiation therapy + surgery); Arm II (Surgery + postoperative radiation therapy)

Contrast Enhanced Digital Mammography PROCEDURE

Undergo CEDM

Also known as: CEDM, Contrast Enhanced Spectral Mammography, Contrast-Enhanced Digital Mammography

Arm I (Preoperative radiation therapy + surgery); Arm II (Surgery + postoperative radiation therapy)

Hypofractionated Radiation Therapy RADIATION

Undergo hypofractionated radiotherapy

Also known as: Hypofractionated, Hypofractionated Radiotherapy, hypofractionation, Radiation, Hypofractionated

Arm I (Preoperative radiation therapy + surgery); Arm II (Surgery + postoperative radiation therapy)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Arm I (Preoperative radiation therapy + surgery); Arm II (Surgery + postoperative radiation therapy)

Positron Emission Tomography PROCEDURE

Undergo PET

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Arm I (Preoperative radiation therapy + surgery); Arm II (Surgery + postoperative radiation therapy)

Survey Administration OTHER

Ancillary studies

Arm I (Preoperative radiation therapy + surgery); Arm II (Surgery + postoperative radiation therapy)

Tissue Collection PROCEDURE

Undergo tissue collection

Also known as: Tissue Bank, Tissue Repository, Tissue/Specimen Collection

Arm I (Preoperative radiation therapy + surgery); Arm II (Surgery + postoperative radiation therapy)

Ultrasound Imaging PROCEDURE

Undergo ultrasound

Also known as: 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography, Ultrasound, Ultrasound Test, Ultrasound, Medical, US

Arm I (Preoperative radiation therapy + surgery); Arm II (Surgery + postoperative radiation therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Specimen Handling; Mastectomy, Segmental; Drug Therapy; Radiation Dose Hypofractionation; Radiation; Magnetic Resonance Spectroscopy; Tissue Banks; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Mastectomy; Surgical Procedures, Operative; Therapeutics; Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Physical Phenomena; Spectrum Analysis; Chemistry Techniques, Analytical; Biological Specimen Banks; Health Facilities; Health Care Facilities Workforce and Services; Ultrasonic Waves; Sound; Radiation, Nonionizing

Study Officials

• Carlos E. Vargas, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 10, 2024
• Study Start: May 14, 2025
• Primary Completion (Estimated): October 21, 2031
• Study Completion (Estimated): October 21, 2034
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

US (1)