Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer

Официальное название

Screening Magnetic Resonance Imaging of the Brain in Patients With Metastatic Breast Cancer Managed With First/Second Line Chemotherapy or Inflammatory Breast Cancer Managed With Definitive Intent: A Prospective Study

Обзор

This research study is studying the usefulness of magnetic resonance imaging (MRI) to screen for brain metastases (spread of the breast cancer to the brain).

Подробное описание

This research study is a Phase II clinical trial. Phase II clinical trials examine the safety and effectiveness of an investigational intervention, in this case magnetic resonance imaging (MRI) of the brain, to learn whether it is helpful in managing a specific disease.

In this research study, the investigators are utilizing screening MRIs of the brain to evaluate breast cancer patients for metastases to the brain. The investigators hope to understand whether screening MRIs of the brain can be implemented into the standard of care to earlier detect brain metastases in a population where screening MRIs of the brain are not currently recommended or systematically performed.

This trial will contain 4 cohorts:

1\. Those with triple negative breast cancer (TNBC) will undergo screening MRI of the brain as part of a single arm, non-comparative study

2+3. Those with hormone receptor positive/(human epidermal growth factor receptor 2 (HER2) negative (HR+/HER2-) and HER2 positive (HER2+) subtypes will be randomized to receipt of screening MRI of the brain or no screening MRI of the brain to definitively test the value of MRI screening.

4\. Patients with inflammatory breast cancer being treated with curative intent will undergo screening MRI of the brain as part of a single arm, non-comparative study.

Вмешательства

• Устройство MRI
  MRI (which stands for magnetic resonance imaging) provide imaging of the brain which help look for brain metastases (spread of the breast cancer to the brain).

Первичные конечные точки

• Neurologic Quality of Life at 12 Months using the MD Anderson Symptom Inventory - Brain Tumor Module [Срок оценки: 12 Months]
• Incidence of Symptomatic Brain Metastases [Срок оценки: Through study completion, an average of 1 year]
• Incidence of Brain Metastases [Срок оценки: Through study completion, an average of 1 year]

Вторичные конечные точки (12)

• Number of brain metastases [Срок оценки: Through study completion, an average of 1 year]
• Size of brain metastases [Срок оценки: Through study completion, an average of 1 year]
• Development of metastases in the brainstem as seen on magnetic resonance imaging of the brain [Срок оценки: Through study completion, an average of 1 year]
• Development of leptomeningeal carcinomatosis as seen on magnetic resonance imaging of the brain [Срок оценки: Through study completion, an average of 1 year]
• Radiographic appearance of brain metastases [Срок оценки: Through study completion, an average of 1 year]
• Development of symptomatic brain metastases based on review of medical notes / history [Срок оценки: Through study completion, an average of 1 year]
• Neurologic death [Срок оценки: Through study completion, an average of 1 year]
• All-cause mortality [Срок оценки: Through study completion, an average of 1 year]
• Development of seizures based on review of medical notes / history [Срок оценки: Through study completion, an average of 1 year]
• Receipt of whole brain radiation due to brain metastases [Срок оценки: Through study completion, an average of 1 year]
• Receipt of neurosurgical resection due to brain metastases [Срок оценки: Through study completion, an average of 1 year]
• Quality of life assessment via EuroQol Group 5D Instrument [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

• Participants must have histologically or cytologically confirmed breast cancer with pathologic assessment of estrogen receptor (ER), progesterone receptor (PR), and (human epidermal growth factor receptor 2 (HER2) status. If subtype has changed over the course of a patient's disease, the treating clinician and/or study PI is responsible for selecting the subtype that most likely reflects the preponderance of oncologic disease at the time of enrollment.
• Participants must have radiographic evidence of extracranial, distant metastases or unresectable, locally recurrent breast cancer and be initiating (within 8 weeks of registration) first-line or second-line chemotherapy for their metastatic/recurrent disease OR inflammatory breast cancer being managed with curative intent within six months of diagnosis.
• Participants must be age 18 years or older.
• Participants must have a life expectancy of greater than 12 weeks.
• Participants must be willing to undergo study procedures.
• The effects of gadolinium / other magnetic resonance imaging (MRI)-based contrast agents on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
• Participants must possess the ability to understand and the willingness to sign a written informed consent document.

Критерии исключения

• Participants who have a contraindication to MRI (e.g. noncompatible implanted metallic device for which MRI is absolutely contraindicated).
• Participants who have chronic kidney disease stage IV-V or end stage renal disease.
• Participants with a history of anaphylactic reactions to gadolinium.
• Pregnant women are excluded from this study because gadolinium-based agents have not been proven to be safe to administer to a developing fetus. Similarly, breastfeeding women will be excluded from this study.
• Patients with a prior diagnosis of brain metastases

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

США · 1 центр

• Brigham and Women's Hospital — Boston

Идентификаторы

NCT: NCT04030507 · 19-066

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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