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

Официальное название

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

Обзор

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.

Вмешательства

• Лучевая терапия MRIdian Radiation Treatment Unit
  partial breast irradiation using 3 x 8.2 Gy to the lumpectomy cavity with a 3mm planning tumor volume (PTV) margin

Первичные конечные точки

• Physician Reported Cosmesis: 1-year [Срок оценки: up to 1-year]

Вторичные конечные точки (11)

• Participant Quality of Life: BCTOS Survey [Срок оценки: up to 5 years]
• Participant Quality of Life: Convenience of Care Scale [Срок оценки: up to 5 years]
• Participant Quality of Life: MOS SF-36 Survey [Срок оценки: up to 5 years]
• Physician Reported Cosmesis: 3-year [Срок оценки: up to 3 years]
• Physician Evaluated Fat Necrosis [Срок оценки: up to 5 years]
• Acute Radiation Toxicity [Срок оценки: up to 90 days from completion of radiation therapy]
• Late Radiation Toxicity [Срок оценки: up to 5 years]
• Ipsilateral Breast Tumor Recurrence (IBTR) [Срок оценки: up to 5 years]
• Ipsilateral Regional Nodal Recurrence [Срок оценки: up to 5 years]
• Disease Free Survival (DFS) [Срок оценки: up to 5 years]
• Overall Survival (OS) [Срок оценки: up to 5 years]

Критерии участия

Критерии включения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Wisconsin Carbone Cancer Center — Madison

Идентификаторы

NCT: NCT03936478 · 2019-0322 · NCI-2019-03111 · UW18099 · SMPH\HUMAN ONCO\HUMAN ONCO · A533300 · Protocol Version 5/24/2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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