Real-Time MRI-Guided 3-Fraction Accelerated Partial Breast Irradiation in Early Breast Cancer

NCT03936478 | Recruiting Phase 2 DMC FDA Device

• 6 other identifiers: UW180992019-0322SMPH\HUMAN ONCO\HUMAN ONCOA533300NCI-2019-03111Protocol Version 5/10/2021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will investigate a novel 3-fraction radiation regimen for participants undergoing breast-conserving therapy (BCT) for early breast cancer that will: 1) significantly reduce the duration of treatment and can be completed in one-week (5 working days) and 2) MRI-guided radiotherapy (MRIdian) would limit the volume of normal tissue radiated and therefore resultant toxicity. The hypothesis is that 3-fraction radiation therapy can be delivered safely without compromising the therapeutic ratio. Participants can expect to be on study for follow up up to 5 years.

Conditions

Breast Cancer; DCIS; LCIS

Keywords

cosmesis; cosmetic; breast-conserving therapy

Outcome Measures

Primary Outcomes (1)

• Physician Reported Cosmesis: 1-year

  The Harvard Cosmesis Scale will be used to report cosmesis at 1 year post treatment. The physician will report how the breast looks relative to original appearance or untreated breast (excellent, good, fair, poor). The physician answers 9 questions on a scale of 0-2 where 0 is none, 1 is present but does not affect cosmesis, 2 is present and affects cosmesis. Scoring is objective with lower scores indicating improved conditions.

  up to 1-year

Secondary Outcomes (11)

• Participant Quality of Life: BCTOS Survey

  up to 5 years

• Participant Quality of Life: Convenience of Care Scale

  up to 5 years

• Participant Quality of Life: MOS SF-36 Survey

  up to 5 years

• Physician Reported Cosmesis: 3-year

  up to 3 years

• Physician Evaluated Fat Necrosis

  up to 5 years

Study Arms (1)

8.2 Gy Radiation Therapy

EXPERIMENTAL

Accelerated partial breast irradiation using 3 x 8.2 Gy to the lumpectomy cavity with a 3mm PTV margin. Treatment duration will be 5-6 days and treatments will be on alternative weekdays, with a minimum interval of 40 hours between subsequent fractions.

Radiation: MRIdian Radiation Treatment Unit

Interventions

MRIdian Radiation Treatment Unit RADIATION

partial breast irradiation using 3 x 8.2 Gy to the lumpectomy cavity with a 3mm planning tumor volume (PTV) margin

8.2 Gy Radiation Therapy

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For all participants
• Participants should have no contraindications to undergo MRI scan as part of radiotherapy planning and treatment.
• Lumpectomy cavity must be clearly visible on CT and MRI scan at radiotherapy simulation.
• Pregnancy test negative in women of child bearing potential (WOCBP).
• The participant must consent to be in the study and must have signed an approved consent form conforming with institutional guidelines.
• Participants with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior and are deemed by their physician to be at low risk for recurrence. Participants with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
• For participants with Invasive Carcinoma
• Suitable:
• Age: \>=50 years
• Margins: Negative by at least 2 mm
• T Stage: Tis or T1
• Cautionary:
• Age: 40-49 years
• Margins: Negative by at least 2 mm
• T Stage: Tis or T1 OR

You may not qualify if:

• Men are not eligible for this study.
• BRCA1/2 mutation positivity.
• Age \< 40 years (American Society for Radiation Oncology (ASTRO) Unsuitable Criteria).
• Positive resection margins on post operative pathology(ASTRO Unsuitable Criteria).
• Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
• Suspicious micro calcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
• Non-epithelial breast malignancies such as sarcoma or lymphoma.
• Proven multicentric carcinoma (invasive cancer or DCIS) (ASTRO Unsuitable Criteria).
• Pure DCIS \>3 cm in size (ASTRO Unsuitable Criteria).
• Presence of extensive intraductal component \>30mm (ASTRO Unsuitable Criteria).
• Paget's disease of the nipple.
• History of previous invasive breast cancer, DCIS, synchronous bilateral invasive or non-invasive breast cancer. (Participants with a history of LCIS treated by surgery alone are eligible.)
• Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation.
• Concurrent therapy with any hormonal agents such as raloxifene (Evista®), tamoxifen, Aromatase Inhibitors or other selective estrogen receptor modulators (SERMs), either for osteoporosis or breast cancer prevention or neoadjuvant therapy.
• Breast implants.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53705, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Study Officials

• Bethany Anderson, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cancer Connect

CONTACT

800-622-8922; clinicaltrials@cancer.wisc.edu

Study Design

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

Model Details: This study will have a lead-in phase consisting of 10 patients, followed for 6-months from the date of completion of radiotherapy for the tenth patient. The second phase of accrual (20 patients) will commence only if three or fewer patients (3/10=30%) have CTCAE v 5.0 grade 3 or higher skin toxicity (radiation dermatitis) or Lövey et al. grade 3 or higher fat necrosis.

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: May 3, 2019
• Study Start: May 16, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2031
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)