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

NCT ID: NCT03936478

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-16
• Study Completion Date: 2031-01-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

8.2 Gy Radiation Therapy

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.

Group Type: EXPERIMENTAL

MRIdian Radiation Treatment Unit

Intervention Type: RADIATION

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

Interventions

MRIdian Radiation Treatment Unit

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

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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
• Age: >=50 years IF participant has at least 1 of the pathologic factors below and does not have any "unsuitable" factors (below)

• Pathologic Factors:

• Size 2.1-3.0 cm (size of the invasive component)
• T2
• Close margins (<2 mm)
• Limited/focal Lymphovascular Space Invasion (LVSI)
• ER (-)
• Clinically unifocal with total size 2.1-3.0 cm (Microscopic multifocality allowed, provided the lesion is clinically unifocal (a single discrete lesion by physical examination and ultrasonography/mammography) and the total lesion size (including foci of multifocality and intervening normal breast parenchyma) falls between 2.1 and 3.0 cm).
• Invasive lobular histology
• Extensive Intraductal Component (EIC) <=3 cm

For participants with DCIS

• Suitable Criteria, DCIS allowed if all of the following are met:

• Screen-detected
• Low to intermediate nuclear grade
• Size <=2.5 cm
• Resected with margins negative at >=3mm OR
• Cautionary Criteria:

• Pure DCIS <=3 cm if "suitable" criteria not fully met

Exclusion Criteria

• 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.
• Prior breast or thoracic radiotherapy for any condition or treatment plan that includes regional nodal irradiation.
• Collagen vascular disease, specifically dermatomyositis with a creatinine phosphokinase level above normal or with an active skin rash, systemic lupus erythematosus, or scleroderma.
• Pregnancy or lactation at the time of treatment. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.
• Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the participant from meeting the study requirements.

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bethany Anderson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cancer Connect

Role: CONTACT

clinicaltrials@cancer.wisc.edu

800-622-8922

Facility Contacts

Cancer Connect

Role: primary

clinicaltrials@cancer.wisc.edu

800-622-8922

Other Identifiers

2019-0322

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH\HUMAN ONCO\HUMAN ONCO

Identifier Type: OTHER

Identifier Source: secondary_id

A533300

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2019-03111

Identifier Type: REGISTRY

Identifier Source: secondary_id

Protocol Version 5/10/2021

Identifier Type: OTHER

Identifier Source: secondary_id

UW18099

Identifier Type: -

Identifier Source: org_study_id