MRI-Guided Radiation for Early Breast Cancer

(MAPBI Trial)

Overseen By Cancer Connect

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Wisconsin, Madison

Must not be taking: Hormonal agents

Disqualifiers: Men, BRCA1/2 mutation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 week

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new, quicker radiation treatment for early breast cancer. It uses MRI technology to target cancer more precisely, reducing the risk of unwanted side effects. The MRIdian Radiation Treatment Unit aims to complete treatment in just one week, unlike the usual longer duration. Candidates include those who have had a lumpectomy (breast-conserving surgery) and meet specific criteria, such as having a clearly visible lumpectomy cavity on imaging. This trial may suit those seeking to minimize treatment time while ensuring effective care. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in cancer care.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications, but it does exclude participants who are on hormonal agents like tamoxifen or aromatase inhibitors. It's best to discuss your specific medications with the trial team.

What prior data suggests that MRI-guided radiotherapy is safe for early breast cancer treatment?

Research has shown that MRI-guided radiotherapy, such as the MRIdian Radiation Treatment Unit, may reduce side effects by precisely targeting the tumor and protecting healthy tissue. A review found that this method improves tumor targeting accuracy and reduces radiation exposure to normal tissues, potentially leading to fewer side effects.

In another study, patients who received stereotactic MRI-guided radiation therapy reported manageable side effects. While some side effects may occur, they are usually mild and tolerable.

As this trial is in the early stages, safety remains under close observation. However, current research suggests that this type of radiation therapy is generally well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for early breast cancer?

Researchers are excited about the MRIdian radiation treatment for early breast cancer because it offers a unique approach compared to traditional radiation therapies. Unlike conventional treatments that often involve whole-breast irradiation over several weeks, this technique uses MRI guidance to deliver precise, accelerated partial breast irradiation to the lumpectomy cavity. This means the treatment is highly targeted, minimizing exposure to surrounding healthy tissue, and can be completed in just 5–6 days with fewer sessions. This not only potentially reduces side effects but also significantly shortens the overall treatment time, making it a promising option for patients seeking efficient and effective care.

What evidence suggests that MRI-guided radiotherapy is effective for early breast cancer?

Research has shown that MRI-guided radiotherapy can precisely target tumors in breast cancer treatment. This method protects healthy tissue from radiation, leading to fewer side effects. Although few studies focus specifically on breast cancer, MRI-guided radiotherapy is considered a promising option with the potential to significantly impact treatment. Early results indicate that the MRIdian Radiation Treatment Unit, which participants in this trial will receive, enhances treatment accuracy and reduces harm to nearby healthy areas. This approach may also shorten treatment time, a major benefit for many patients. ^{1 4 6 7 8}

Who Is on the Research Team?

Bethany Anderson, MD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for individuals with early-stage breast cancer who have undergone a lumpectomy. Participants must be able to undergo MRI scans, which are used in planning and delivering the treatment, and their lumpectomy cavity should be visible on CT and MRI. Women of childbearing potential must test negative for pregnancy. Those with a history of non-breast cancers can join if they've been disease-free for 5+ years or had certain skin or localized cancers within that time.

Inclusion Criteria

The area where my lump was removed is clearly seen on scans.

Pregnancy test negative in women of child bearing potential (WOCBP).

I can safely have an MRI scan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a novel 3-fraction radiation regimen over 5-6 days, with treatments on alternative weekdays and a minimum interval of 40 hours between fractions

1 week

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including quality of life and cosmesis up to 5 years

5 years

Regular visits (in-person and virtual) at specified intervals

What Are the Treatments Tested in This Trial?

Interventions

• MRIdian Radiation Treatment Unit

Trial Overview The study is testing an innovative radiation therapy delivered in just three sessions over one week using the MRIdian system, which combines MRI imaging with radiation therapy to target tumors more precisely while sparing healthy tissue. The goal is to see if this quick treatment can effectively control cancer without causing significant side effects.

How Is the Trial Designed?

Group I: 8.2 Gy Radiation Therapy Experimental Treatment 1 Intervention

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.

MRIdian Radiation Treatment Unit is already approved in United States, European Union, Canada for the following indications:

Approved in United States as MRIdian Radiation Treatment Unit for:

• Early-stage invasive breast cancer
• Ductal carcinoma in situ (DCIS)

Approved in European Union as MRIdian Radiation Treatment Unit for:

• Early-stage invasive breast cancer
• Ductal carcinoma in situ (DCIS)

Approved in Canada as MRIdian Radiation Treatment Unit for:

• Early-stage invasive breast cancer
• Ductal carcinoma in situ (DCIS)

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Published Research Related to This Trial

Accelerated partial breast irradiation (APBI) using an MR-Linac is feasible in both prone and supine positions, with all treatment plans meeting target coverage and organ-at-risk (OAR) constraints for 20 patients studied.

The prone position resulted in significantly lower radiation exposure to the ipsilateral lung and shorter estimated delivery times, although most patients preferred the supine position for comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prone vs. supine accelerated partial breast irradiation on an MR-Linac: A planning study. Groot Koerkamp, ML., van der Leij, F., van 't Westeinde, T., et al.[2021]

In a study involving 30 women with early-stage breast cancer, the use of MR-guided radiation therapy for accelerated partial-breast irradiation showed minimal intrafractional motion of the surgical cavity, with an average displacement of only 0.6 mm.

The difference between the planned and delivered radiation dose was very small, at just 0.6%, indicating that this method effectively delivers the intended treatment with high precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Image Guided Radiation Therapy for External Beam Accelerated Partial-Breast Irradiation: Evaluation of Delivered Dose and Intrafractional Cavity Motion. Acharya, S., Fischer-Valuck, BW., Mazur, TR., et al.[2022]

Magnetic resonance-guided radiation therapy (MRgRT) is increasingly utilized in the US, with a 59.6% annual growth rate in treatment courses from 2014 to 2020, particularly for ultra-hypofractionated regimens, which accounted for 70.3% of all courses.

The technology has shown a significant shift towards adaptive radiation therapy, with 38.5% of treatment courses involving adaptive fractions, especially in ultra-hypofractionated schedules, indicating a major advancement in the precision and personalization of cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of utilization and clinical adoption of 0.35 Tesla MR-guided radiation therapy in the United States - Understanding the transition to adaptive, ultra-hypofractionated treatments. Chuong, MD., Clark, MA., Henke, LE., et al.[2022]

In a study involving 10 early-stage breast cancer patients, the use of an MRI/linac system during whole-breast irradiation (WBI) increased the skin dose due to the electron return effect, which could be a concern for treatment safety.

Conversely, during accelerated partial-breast irradiation (APBI), the magnetic field had negligible effects on skin dose, suggesting that MR-guided partial-breast treatments could be a promising option for improving radiotherapy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR-guided breast radiotherapy: feasibility and magnetic-field impact on skin dose. van Heijst, TC., den Hartogh, MD., Lagendijk, JJ., et al.[2022]

Neoadjuvant partial breast irradiation (PBI) is being researched to minimize the amount of breast tissue exposed to radiation, which could lower the risk of long-term side effects from treatment.

Magnetic resonance (MR)-guided radiotherapy, particularly using MR-linac systems, may enhance tumor visibility during treatment, potentially allowing for even more precise targeting and reduced radiation exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing MR-Guided Radiotherapy for Breast Cancer Patients. Groot Koerkamp, ML., Vasmel, JE., Russell, NS., et al.[2021]

In a study of 180 women evaluated for accelerated partial breast irradiation (APBI), breast MRI identified additional cancerous lesions in 12% of candidates, highlighting its importance in detecting multifocal or multicentric disease before treatment.

Premenopausal women and those with tumors larger than 2 cm were more likely to have MRI-detected multifocal or multicentric disease, suggesting that these factors may influence the effectiveness of MRI in identifying the extent of breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining an optimal role for breast magnetic resonance imaging when evaluating patients otherwise eligible for accelerated partial breast irradiation. Horst, KC., Fero, KE., Ikeda, DM., et al.[2019]

Breast MRI detected synchronous mammographically occult lesions in 5.8% of early-stage breast cancer patients, highlighting its potential to identify additional cancers that might affect treatment decisions for accelerated partial breast irradiation (APBI).

The study found that certain factors, such as lobular histology and higher cancer stages, were significantly associated with the presence of additional ipsilateral disease, suggesting that MRI could be particularly beneficial for specific patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative breast magnetic resonance imaging in early breast cancer: implications for partial breast irradiation. Tendulkar, RD., Chellman-Jeffers, M., Rybicki, LA., et al.[2009]

The MRIdian® MR linear accelerator in the UK has successfully implemented Stereotactic MRI-guided Adaptive Radiotherapy (SMART) for treating hepatobiliary cancers, allowing for precise targeting and real-time adjustments during treatment for 50 patients in just five months.

SMART offers significant advantages such as excellent soft tissue visualization, daily recontouring of targets, and automatic respiratory-gated treatment delivery, making it suitable for complex tumors that may not be treatable with traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of Stereotactic MRI-Guided Adaptive Radiotherapy (SMART) for Hepatobiliary and Pancreatic Cancers in the United Kingdom - Fifty in Five. Gaya, A., Camilleri, P., Nash, A., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03936478

Study Details | NCT03936478 | Real-Time MRI-Guided 3- ... This trial will investigate a novel 3-fraction radiation regimen for participants undergoing breast-conserving therapy (BCT) for early breast cancer that ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8892442/

Use of magnetic resonance image‐guided radiotherapy for ... Currently, there are limited studies to demonstrate the clinical effectiveness of MRI guided radiotherapy (MRIgRT) treatment for breast cancer ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2452109421000129

Improved Ipsilateral Breast and Chest Wall Sparing With ... In this study, we compare the plan quality of ViewRay MRIdian Linac forward planned intensity modulated radiation therapy and TrueBeam volumetric modulated arc ...

4. withpower.com withpower.com/trial/phase-3-breast-neoplasms-9-2021-36665

MRI-Guided Radiation for Early Breast Cancer (MAPBI Trial) Research shows that MRI-guided radiotherapy can improve the accuracy of targeting the tumor while sparing healthy tissue, which is beneficial for treatments ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9728922/

The initial experience of MRI-guided precision prone ... MRI-guided partial breast radiotherapy as a breast radiotherapy technology is feasible and is a potential high clinical impact application of MRgRT.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7852080/

Use of magnetic resonance imaging-guided radiotherapy ... The results from this review will consolidate the evidence surrounding MRI-guided radiotherapy for breast cancer, contributing to the development and ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1879850025000980

Partial Breast Radiation Therapy in Low-Risk ... This study investigates the feasibility of stereotactic magnetic resonance imaging-guided adaptive radiation therapy (SMART) for PBI, with emphasis on toxicity ...

8. thegreenjournal.com thegreenjournal.com/article/S0167-8140(21)06746-3/fulltext

Implementing stereotactic accelerated partial breast ... This MR-guided stereotactic APBI (MRgS-APBI) approach can be utilized for a lower number of fractions and spare a greater volume of healthy tissues.