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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT06635980
Phase
PHASE2
Status
Recruiting
Apply to this trial

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 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy of Breast — PROCEDURE
    Undergo breast biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Breast Surgery — PROCEDURE
    Undergo breast surgery
  • Chemotherapy — DRUG
    Receive SOC chemotherapy
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Contrast Enhanced Digital Mammography — PROCEDURE
    Undergo CEDM
  • Hypofractionated Radiation Therapy — RADIATION
    Undergo hypofractionated radiotherapy
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Positron Emission Tomography — PROCEDURE
    Undergo PET
  • Survey Administration — OTHER
    Ancillary studies
  • Tissue Collection — PROCEDURE
    Undergo tissue collection
  • Ultrasound Imaging — PROCEDURE
    Undergo ultrasound

Study Details

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.

Key Dates

Start date
May 14, 2025
Status verified
Dec 2025
Primary completion
Oct 21, 2031
Completion
Oct 21, 2034

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259
Clinical Trials Referral Office
[email protected]
855-776-0015
Carlos E. Vargas, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Scottsdale, AZ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Mayo Clinic in Arizona· Scottsdale, AZ

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