Brain-Spray chemo cocktail targets breast Cancer's deadliest spread

NCT ID NCT06543992

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This phase II trial tests whether injecting two chemotherapy drugs—thiotepa and methotrexate—directly into the spinal fluid can shrink or control breast cancer that has spread to the leptomeninges (the lining of the brain and spinal cord). Participants receive the drugs through an implanted Ommaya reservoir, a device that allows repeated access to the spinal fluid. The study will measure how many patients respond and how long the response lasts, while monitoring safety.

What this could mean

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

Active substance
a combination of thiotepa and methotrexate given directly into the spinal fluid via an Ommaya reservoir
What this could lead to
If successful, this could offer a new treatment option for breast cancer that has spread to the lining of the brain and spinal cord, potentially improving response rates and delaying disease progression.
What could go wrong
This is a small, early-phase trial with only 22 participants, so results may not apply broadly. The treatment involves direct injection into the spinal fluid, which carries risks like infection, nerve damage, or side effects from the chemotherapy drugs.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 22 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Dec 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 to 75 years

Sex

Female participants only

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: 1. Patient is an adult female ≥18 and ≤75 years old at the time of informed consent. 2. ECGO rating 0-3. 3. Histologically or cytologically confirmed breast cancer. 4. A new diagnosis of LM, established either by the presence of malignant cells in the CSF or by the combination of characteristic clinical manifestations and magnetic resonance imaging (MRI) findings 5. Patients can be implanted or have been implanted with Ommaya reservoirs; 6. Patient must have at least one measurable lesion (according to RECIST 1.1 criteria); 7. Postmenopausal or pre/perimenopausal female patients are eligible for enrolment; pre or perimenopausal female patients must be willing to receive LHRHa during the study period. 8. All patients were required to meet the following laboratory biochemical values prior to enrolment: * Haematology: Hb ≥90 g/L, WBC ≥3.5×109/L, ANC ≥1.5×109/L, PLT ≥100×109/L; * Liver function: for those without liver metastases, AST, ALT, ALP ≤2.5 times the upper limit of normal values, and ≤1.25 x the upper limit of normal values for total bilirubin; for those with liver metastases, AST, ALT, ALP ≤ 5 times the upper limit of normal value, and total bilirubin ≤ 1.5 x upper limit of normal value. Exclusion Criteria: 1. Patients with other malignant tumors, excluding basal cell carcinoma and carcinoma in situ 2. Patients with severe or uncontrolled systemic disease, including uncontrolled hypertension or active bleeding tendency 3. The investigator considers the patient unsuitable for entry into this study. 4. Patients with toxicity from prior therapy that has not returned to normal or NCI-CTCAE grade 5.0 5. Patients who have a drug allergy or metabolic disorder to the drugs in this regimen 6. Pregnant or lactating women (women of childbearing age must have had a negative pregnancy test within 14 days prior to the first dose; if positive, pregnancy must be ruled out by ultrasound). 7. Patients who are concurrently enrolled in other clinical studies

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Jiangsu Provincial People's Hospital

    RECRUITING

    Nanjing, Jiangsu, 210000, China

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