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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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Contact Information
Primary
Ayal Aizer, MD, MHS
aaaizer@partners.org
617-732-7560
Backup
Ivy Ricca, BA
iricca@mgb.org
6175828927
Time Frame
Start Date: 2019-07-26
Estimated Completion Date: 2028-02
Participants
Target number of participants: 214
Treatments
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.
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
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
Sponsors
Leads: Brigham and Women's Hospital
Collaborators: Conquer Cancer Foundation, Dana-Farber Cancer Institute

This content was sourced from clinicaltrials.gov

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