NCT04030507

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
21mo left

Started Jul 2019

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Jul 2019Feb 2028

First Submitted

Initial submission to the registry

July 19, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 24, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

July 26, 2019

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

7.5 years

First QC Date

July 19, 2019

Last Update Submit

March 17, 2026

Conditions

Breast CancerMetastatic Breast CancerHER2-positive Breast CancerTriple Negative Breast CancerHormone Receptor Positive Malignant Neoplasm of BreastInflammatory Breast Cancer

Keywords

Breast CancerHER2-positive Breast CancerTriple Negative Breast CancerHormone Receptor Positive Malignant Neoplasm of BreastInflammatory Breast CancerMetastatic breast cancer

Outcome Measures

Primary Outcomes (3)

  • Neurologic Quality of Life at 12 Months using the MD Anderson Symptom Inventory - Brain Tumor Module

    For patients with HR+/HER2- or HER2+ metastatic breast cancer

    12 Months

  • Incidence of Symptomatic Brain Metastases

    For patients with triple negative metastatic breast cancer

    Through study completion, an average of 1 year

  • Incidence of Brain Metastases

    For patients with inflammatory breast cancer managed with curative intent

    Through study completion, an average of 1 year

Secondary Outcomes (16)

  • Number of brain metastases

    Through study completion, an average of 1 year

  • Size of brain metastases

    Through study completion, an average of 1 year

  • Development of metastases in the brainstem as seen on magnetic resonance imaging of the brain

    Through study completion, an average of 1 year

  • Development of leptomeningeal carcinomatosis as seen on magnetic resonance imaging of the brain

    Through study completion, an average of 1 year

  • Radiographic appearance of brain metastases

    Through study completion, an average of 1 year

  • +11 more secondary outcomes

Study Arms (4)

Inflammatory Breast Cancer Managed with Curative Intent

EXPERIMENTAL

* 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.

Device: MRI

HR+ or HER2+ Metastatic Breast Cancer - Screening Arm

EXPERIMENTAL

* 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

Device: MRI

HR+ or HER2+ Metastatic Breast Cancer - No Screening Arm

NO INTERVENTION

No initial MRI screening will be conducted

Triple Negative Breast Cancer

EXPERIMENTAL

* 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

Device: MRI

Interventions

MRIDEVICE

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).

Also known as: Magnetic Resonance Imaging
HR+ or HER2+ Metastatic Breast Cancer - Screening ArmInflammatory Breast Cancer Managed with Curative IntentTriple Negative Breast Cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsTriple Negative Breast NeoplasmsInflammatory Breast Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Ayal Aizer, MD, MHS

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayal Aizer, MD, MHS

CONTACT

617-732-7560aaaizer@partners.org

Ivy Ricca, BA

CONTACT

6175828927iricca@mgb.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 19, 2019

First Posted

July 24, 2019

Study Start

July 26, 2019

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, 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

Locations

US(1)