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Could brain MRIs and spinal taps predict breast cancer spread?

NCT ID NCT05130840

Diagnosis Sponsor: Memorial Sloan Kettering Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study explores whether routine brain MRIs and spinal taps can detect early signs of breast cancer spreading to the brain in people with HER2-positive breast cancer. Researchers will enroll 9 participants to see if these tests are feasible and well-tolerated. The goal is to catch brain metastases before symptoms appear, enabling earlier treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this approach could help detect brain metastases earlier in HER2+ breast cancer patients, allowing for prompt treatment and possibly preventing disease progression.
What could go wrong
This is a very small feasibility study with only 9 participants, so results may not apply to all patients. The procedures (MRI and lumbar puncture) may be uncomfortable or not tolerated by everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

9 people

The number who actually took part.

Started

Jul 2022

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with Stage IV metastatic HER2+ breast cancer without CNS disease s/p 1 or more lines of HER2 directed therapy (Cohort A Only) * Patients with Stage II-III HER2+ breast cancer without CNS disease (Cohort B Only) * Male and Female participants Age ≥18 years * HER2+ as defined by ASCO/CAP guidelines\* * Ability to undergo bedside Lumbar puncture to obtain cerebrospinal fluid; if beside LP is not successful due to patient discomfort or inability to obtain spinal fluid then patients will be offered LP through interventional radiology and patients will continue to be monitored on study * Patients with breast implants and/or tissue expanders are eligible if they are able to safely undergo an MRI * 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 Exclusion Criteria: * Patients who are unable to undergo MRI with gadolinium * Patients with CNS Metastases on Screening MRI * Patients with Positive Cytology on Screening Bedside lumbar puncture

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.