Brain-Spray chemo cocktail targets breast Cancer's deadliest spread
NCT ID NCT06543992
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 22 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Jiangsu Provincial People's Hospital
RECRUITINGNanjing, Jiangsu, 210000, China
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