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CNS Monitoring for Breast Cancer

N/A

Recruiting

Led By Jessica Wilcox, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to provide written informed consent *ASCO/CAP guidelines: HER2+ defined as IHC 3+ positive and/or by ISH average copy number ≥ 6 signals/cell

HER2+ as defined by ASCO/CAP guidelines*

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing whether scanning the brain and testing cerebrospinal fluid can help find HER2-positive breast cancer earlier, so it can be treated sooner.

Who is the study for?

This trial is for men and women over 18 with HER2-positive Stage II-III or IV metastatic breast cancer, but without CNS disease. They must have had at least one line of HER2 therapy and be able to undergo an MRI and a lumbar puncture. It's not open to those who can't have an MRI with gadolinium, already have CNS metastases, or show positive cytology from a lumbar puncture.Check my eligibility

What is being tested?

The study is testing if brain scans (MRI) and cerebrospinal fluid tests (lumbar puncture) can detect early spread of breast cancer to the central nervous system in patients with HER2-positive breast cancer before symptoms appear.See study design

What are the potential side effects?

Potential side effects include discomfort or pain from the lumbar puncture procedure, headache, backache, bleeding around the spine area; for MRI: allergic reaction to dye (gadolinium), claustrophobia during scan.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can sign a consent form and my cancer is HER2 positive according to specific guidelines.

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My cancer is HER2 positive according to specific guidelines.

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I have stage IV HER2+ breast cancer and have received HER2 therapy but don't have brain involvement.

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My breast cancer is Stage II-III, HER2 positive, and has not spread to my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of eligible patients completing initial MRI

Percentage of eligible patients completing cerebrospinal fluid (CSF) evaluation

Trial Design

2Treatment groups

Experimental Treatment

Group I: Stage IV HER2+ breast cancerExperimental Treatment2 Interventions

Once enrolled on study, patients will undergo screening MRI Brain (unless already done as standard of care within 2 months on enrollment to evaluate for CNS disease) as well as lumbar puncture to evaluate for CNS disease. Once on study, patients will undergo LP and MRI Brain at 2 timepoints 6 months apart (+/- 8 weeks). LP will be performed to analyze cerebrospinal fluid for: cytology, circulating tumor cells and cell-free DNA. 6-month intervals for investigations have been based on feedback from patient advocates as well as clinical determination.

Group II: Stage II-III HER2+ breast cancerExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MRI

2009

Completed Phase 2

~1370

Lumbar puncture

2013

Completed Phase 3

~1180

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,935 Previous Clinical Trials

588,841 Total Patients Enrolled

202 Trials studying Breast Cancer

81,117 Patients Enrolled for Breast Cancer

Jessica Wilcox, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Rachna Malani, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

MRI Clinical Trial Eligibility Overview. Trial Name: NCT05130840 — N/A

Breast Cancer Research Study Groups: Stage IV HER2+ breast cancer, Stage II-III HER2+ breast cancer

Breast Cancer Clinical Trial 2023: MRI Highlights & Side Effects. Trial Name: NCT05130840 — N/A

MRI 2023 Treatment Timeline for Medical Study. Trial Name: NCT05130840 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any sign-up opportunities available for this medical experiment?

"Affirmative. According to the information on clinicaltrials.gov, this research project, initially advertised on July 13th 2022 is currently recruiting participants and has set a limit of 20 enrollees at one medical site."

Answered by AI

What is the maximum capacity of participants in this clinical research program?

"Affirmative. According to the information published on clinicaltrials.gov, this trial is still admitting participants and began doing so since July 13th 2022. The study was last edited on November 8th 2022 and requires 20 individuals from a single site for enrolment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Monitoring for Cancer Spread to the Central Nervous System (CNS) in People With Breast Cancer

2022. "Monitoring for Cancer Spread to the Central Nervous System (CNS) in People With Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05130840.