Condition or disease | Intervention/treatment | Phase |
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Breast Cancer HER2-positive Breast Cancer Triple Negative Breast Cancer Hormone Receptor Positive Malignant Neoplasm of Breast Inflammatory Breast Cancer Metastatic Breast Cancer | Device: MRI | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 214 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Screening |
Official Title: | 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 |
Actual Study Start Date : | July 26, 2019 |
Estimated Primary Completion Date : | July 1, 2022 |
Estimated Study Completion Date : | July 1, 2023 |
Arm | Intervention/treatment |
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Experimental: Inflammatory Breast Cancer Managed with Curative Intent
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Device: 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).
Other Name: Magnetic Resonance Imaging
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Experimental: HR+ or HER2+ Metastatic Breast Cancer - Screening Arm
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Device: 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).
Other Name: Magnetic Resonance Imaging
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No Intervention: HR+ or HER2+ Metastatic Breast Cancer - No Screening Arm
No initial MRI screening will be conducted
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Experimental: Triple Negative Breast Cancer
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Device: 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).
Other Name: Magnetic Resonance Imaging
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ayal Aizer, MD, MHS | 617-732-7560 | aaaizer@partners.org |
United States, Massachusetts | |
Brigham and Women's Hospital | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Ayal Aizer 617-732-7560 aaaizer@partners.org | |
Principal Investigator: Ayal Aizer, MD, MHS |
Principal Investigator: | Ayal Aizer, MD, MHS | Brigham and Women's Hospital |
Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | July 19, 2019 | ||||||||||||||
First Posted Date ICMJE | July 24, 2019 | ||||||||||||||
Last Update Posted Date | May 20, 2021 | ||||||||||||||
Actual Study Start Date ICMJE | July 26, 2019 | ||||||||||||||
Estimated Primary Completion Date | July 1, 2022 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||
Change History | |||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer | ||||||||||||||
Official Title ICMJE | 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 | ||||||||||||||
Brief Summary | 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). | ||||||||||||||
Detailed Description |
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. |
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Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Screening |
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Condition ICMJE |
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Intervention ICMJE | Device: 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).
Other Name: Magnetic Resonance Imaging
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||
Estimated Enrollment ICMJE |
214 | ||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||
Estimated Study Completion Date ICMJE | July 1, 2023 | ||||||||||||||
Estimated Primary Completion Date | July 1, 2022 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||||||||
Removed Location Countries | |||||||||||||||
Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT04030507 | ||||||||||||||
Other Study ID Numbers ICMJE | 19-066 | ||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Ayal Aizer, MD, Dana-Farber Cancer Institute | ||||||||||||||
Study Sponsor ICMJE | Dana-Farber Cancer Institute | ||||||||||||||
Collaborators ICMJE | Conquer Cancer Foundation | ||||||||||||||
Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | ||||||||||||||
Verification Date | May 2021 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |