Clinical trial · Interventional
Real-Time MRI-Guided 3-Fraction Accelerated Partial Breast Irradiation in Early Breast Cancer
A Phase II Study of Real-Time MRI-Guided 3-Fraction Accelerated Partial Breast Irradiation in Early Breast Cancer (MAPBI)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| DCIS | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
| LCIS | Breast Lobular Carcinoma In Situ | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRIdian Radiation Treatment Unit | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 8.2 Gy Radiation Therapy
- description
- 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.
- interventionNames
- Radiation: MRIdian Radiation Treatment Unit
Primary outcomes (1)
- measure
- Physician Reported Cosmesis: 1-year
- timeFrame
- up to 1-year
- description
- The Harvard Cosmesis Scale will be used to report cosmesis at 1 year post treatment. The physician will report how the breast looks relative to original appearance or untreated breast (excellent, good, fair, poor). The physician answers 9 questions on a scale of 0-2 where 0 is none, 1 is present but does not affect cosmesis, 2 is present and affects cosmesis. Scoring is objective with lower scores indicating improved conditions.
Secondary outcomes (11)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
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.References
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