MRI-guided radiation therapy for early breast cancer

A Phase II Study of Real-Time MRI-Guided 3-Fraction Accelerated Partial Breast Irradiation in Early Breast Cancer (MAPBI)

This study is testing a new way to give radiation therapy for early breast cancer that uses MRI to protect healthy tissue and can be done in just one week.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 40 Years and up
• Sex: Female
• Sponsor: University of Wisconsin, Madison (Academic / other)
• Drugs / interventions: Radiation
• Locations: 1 site (Madison, Wisconsin)
• Trial ID: NCT03936478 on ClinicalTrials.gov

What this trial studies

This trial investigates a new approach to radiation therapy for early breast cancer, focusing on a 3-fraction regimen that can be completed in just one week. By using MRI guidance, the treatment aims to minimize radiation exposure to healthy tissue, potentially reducing side effects. Participants will be monitored for up to five years to assess the safety and effectiveness of this accelerated treatment. The study seeks to determine if this method can deliver effective therapy without compromising patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are women aged 50 and older with early-stage breast cancer who have undergone lumpectomy and have no contraindications for MRI.

Not a fit: Patients with contraindications to MRI or those with invasive carcinoma not meeting the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce treatment time and improve the quality of life for patients undergoing breast-conserving therapy.

How similar studies have performed: Other studies have shown promise with MRI-guided radiation therapy, suggesting potential for success with this novel approach.

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 (unsuitable 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.

Where this trial is running

Madison, Wisconsin

• University of Wisconsin Carbone Cancer Center — Madison, Wisconsin, United States (Recruiting)

Study contacts

• Principal investigator: Bethany Anderson, MD — University of Wisconsin, Madison
• Study coordinator: Cancer Connect

Conditions Breast Cancer; DCIS; LCIS; cosmesis; cosmetic; breast-conserving therapy