Actively Recruiting

Phase 2
Age: 40Years +
FEMALE
NCT03936478

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

Led by University of Wisconsin, Madison · Updated on 2025-08-01

30

Participants Needed

1

Research Sites

450 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 40Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female participants aged 40 years or older
  • No contraindications for MRI scans
  • Lumpectomy cavity clearly visible on CT and MRI scans for radiotherapy planning
  • Negative pregnancy test for women of childbearing potential
  • Signed informed consent to participate
  • History of non-breast cancers allowed if disease-free for 5+ years or specific in situ cancers treated within 5 years
  • For invasive carcinoma: suitable if age 50+ with negative margins (≥2 mm) and Tis or T1 stage
  • Cautionary invasive carcinoma: age 40-49 with negative margins (≥2 mm) and Tis or T1; or age 50+ with certain pathologic factors but no unsuitable factors
  • For DCIS: suitable if screen-detected, low to intermediate grade, size ≤2.5 cm, resected with margins ≥3 mm; cautionary if pure DCIS ≤3 cm without meeting all suitable criteria
Not Eligible

You will not qualify if you...

  • Male gender
  • BRCA1/2 mutation positive
  • Age under 40 years
  • Positive surgical resection margins
  • Suspicious or confirmed cancerous lymph nodes unless proven negative by biopsy
  • Suspicious breast abnormalities unless benign by biopsy
  • Non-epithelial breast cancers (e.g., sarcoma, lymphoma)
  • Proven multicentric carcinoma or pure DCIS >3 cm
  • Extensive intraductal component >30 mm
  • Paget's disease of the nipple
  • Previous invasive breast cancer, DCIS, or bilateral breast cancer (except LCIS treated by surgery alone)
  • Unassessable or positive surgical margins
  • Concurrent hormonal therapies or neoadjuvant therapy
  • Breast implants
  • Prior breast or thoracic radiation therapy including regional nodal irradiation
  • Certain collagen vascular diseases (dermatomyositis, lupus, scleroderma)
  • Pregnancy or lactation; must use non-hormonal contraception if of reproductive potential
  • Psychiatric, addictive, or other conditions preventing study compliance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States, 53705

Actively Recruiting

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Research Team

C

Cancer Connect

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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