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

• ClinicalTrials.gov Identifier: NCT04030507
• Recruitment Status: Recruiting
• First Posted: July 24, 2019
• Last Update Posted: September 25, 2023
• Sponsor: Dana-Farber Cancer Institute
• Collaborator: Conquer Cancer Foundation
• Information provided by (Responsible Party): Ayal Aizer, MD, Dana-Farber Cancer Institute

Tracking Information

• First Submitted Date: July 19, 2019
• First Posted Date: July 24, 2019
• Last Update Posted Date: September 25, 2023
• Actual Study Start Date: July 26, 2019
• Estimated Primary Completion Date: February 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 22, 2019)

• Neurologic Quality of Life at 12 Months using the MD Anderson Symptom Inventory - Brain Tumor Module [ Time Frame: 12 Months ]
  For patients with HR+/HER2- or HER2+ metastatic breast cancer
• Incidence of Symptomatic Brain Metastases [ Time Frame: Through study completion, an average of 1 year ]
  For patients with triple negative metastatic breast cancer
• Incidence of Brain Metastases [ Time Frame: Through study completion, an average of 1 year ]
  For patients with inflammatory breast cancer managed with curative intent

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 22, 2019)

• Number of brain metastases [ Time Frame: Through study completion, an average of 1 year ]
• Size of brain metastases [ Time Frame: Through study completion, an average of 1 year ]
• Development of metastases in the brainstem as seen on magnetic resonance imaging of the brain [ Time Frame: Through study completion, an average of 1 year ]
• Development of leptomeningeal carcinomatosis as seen on magnetic resonance imaging of the brain [ Time Frame: Through study completion, an average of 1 year ]
• Radiographic appearance of brain metastases [ Time Frame: Through study completion, an average of 1 year ]
• Development of symptomatic brain metastases based on review of medical notes / history [ Time Frame: Through study completion, an average of 1 year ]
• Neurologic death [ Time Frame: Through study completion, an average of 1 year ]
• All-cause mortality [ Time Frame: Through study completion, an average of 1 year ]
• Development of seizures based on review of medical notes / history [ Time Frame: Through study completion, an average of 1 year ]
• Receipt of whole brain radiation due to brain metastases [ Time Frame: Through study completion, an average of 1 year ]
• Receipt of neurosurgical resection due to brain metastases [ Time Frame: Through study completion, an average of 1 year ]
• Quality of life assessment via EuroQol Group 5D Instrument [ Time Frame: Through study completion, an average of 1 year ]
• Neurocognitive function using the Hopkins Verbal Learning Test Instrument [ Time Frame: Through study completion, an average of 1 year ]
• Neurocognitive function using the Trail Making Test Instrument [ Time Frame: Through study completion, an average of 1 year ]
• Neurocognitive function using the Controlled Oral Word Association Test [ Time Frame: Through study completion, an average of 1 year ]
• Neurocognitive function using the Mini-Mental Status Exam Instrument [ Time Frame: Through study completion, an average of 1 year ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer
• 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Screening

Condition

• Breast Cancer
• HER2-positive Breast Cancer
• Triple Negative Breast Cancer
• Hormone Receptor Positive Malignant Neoplasm of Breast
• Inflammatory Breast Cancer
• Metastatic Breast Cancer

Intervention

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

Study Arms

• Experimental: Inflammatory Breast Cancer Managed with Curative Intent
  • Patients will receive an initial screening magnetic resonance imaging (MRI) of the brain
  • If no evidence of intracranial involvement is identified, additional screening MRIs of the brain every six months for two years and at initial systemic progression.
  Intervention: Device: MRI
• Experimental: HR+ or HER2+ Metastatic Breast Cancer - Screening Arm
  • An initial MRI screening will be conducted
  • If negative, patients will receive a second MRI of the brain at first systemic progression after study entry
  Intervention: Device: MRI
• No Intervention: HR+ or HER2+ Metastatic Breast Cancer - No Screening Arm
  No initial MRI screening will be conducted
• Experimental: Triple Negative Breast Cancer
  • An initial MRI screening will be conducted
  • If negative, patients will receive a second MRI of the brain at first systemic progression after study entry
  Intervention: Device: MRI

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 22, 2019): 214
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 2026
• Estimated Primary Completion Date: February 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Ayal Aizer, MD, MHS; 617-732-7560; aaaizer@partners.org

Contact: Ivy Ricca, BA; 6175828927; iricca@mgb.org

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04030507
• Other Study ID Numbers: 19-066
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

• Current Responsible Party: Ayal Aizer, MD, Dana-Farber Cancer Institute
• Original Responsible Party: Ayal Aizer, Dana-Farber Cancer Institute, Principal Investigator
• Current Study Sponsor: Dana-Farber Cancer Institute
• Original Study Sponsor: Same as current
• Collaborators: Conquer Cancer Foundation

Investigators

• Principal Investigator: Ayal Aizer, MD, MHS; Brigham and Women's Hospital

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: September 2023