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One-Week radiation for breast cancer: MRI precision may cut side effects

NCT ID NCT03936478

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new radiation approach for early breast cancer that uses real-time MRI guidance to deliver just three high-dose sessions over one week, instead of the usual several weeks. The goal is to see if this shorter treatment is safe, preserves the breast's appearance, and limits damage to healthy tissue. The trial enrolls people who have had a lumpectomy for early-stage breast cancer or certain precancers, and follows them for up to five years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MRI-guided partial breast irradiation (3 fractions of 8.2 Gy)
What this could lead to
If successful, this could offer a shorter, more precise radiation option for early breast cancer, potentially reducing side effects and improving cosmetic outcomes.
What could go wrong
This is a small phase 2 study with only 30 participants, so results may not apply to all patients. The long-term safety and effectiveness beyond 5 years are not yet known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • University of Wisconsin Carbone Cancer Center

    RECRUITING

    Madison, Wisconsin, 53705, United States

    Contact Email: •••••@•••••

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