Spinal fluid injection shows promise for breast cancer brain spread
NCT ID NCT01373710
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a new way to give the drug trastuzumab (Herceptin) to women with HER2-positive breast cancer that had spread to the lining of the brain. Instead of through a vein, the drug was injected directly into the spinal fluid via a lumbar puncture or a special reservoir. The goal was to find a safe dose and see if it could control the cancer in the brain. The trial enrolled 34 participants and looked at side effects and how long the cancer stayed stable.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- trastuzumab (Herceptin) injected into the spinal fluid
- What this could lead to
- If it works, this could offer a way to treat breast cancer that has spread to the lining of the brain, potentially slowing the disease and improving symptoms.
- What could go wrong
- This is an early-phase trial with only 34 participants, so results may not apply to everyone. The treatment involves direct spinal injections, which carries risks like infection or nerve damage, and it may not control the cancer long-term.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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34 people
The number who actually took part.
- Started
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May 2011
- Finished
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Apr 2018
- 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 years and older
- Sex
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Anyone
- 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: * Metaplastic Infiltrating adenocarcinoma of the breast * HER2 Overexpression by IHC and / or amplification (FISH and or ICHS) * Positive diagnosis of neoplastic meningitis: positive CSF cytology (obtained within 28 days before inclusion) AND / OR clinical symptoms of neoplastic meningitis and aspect of tumoral meningitis on MRI * Brain metastases are allowed without prior treatment, if they are asymptomatics and without engagement. In cases of symptomatic brain metastases, subjects could be included only if surgery and / or radiotherapy (stereotactic or in toto) were performed and if the cerebral metastatic localization allow IT or intra-ventricular treatment. The last radiotherapy session or the surgery must have been done 3 weeks before. * Aged 18 years old or more * Male and female * Life expectancy more than 2 months * Satisfactory Cardiac function: left ventricular ejection fraction (LVEF) determined by ultrasound scan or myocardial scintigraphy * Adequate Biological functions 14 days before inclusion, according to the criteria below: Neutrophils \> 1.0 x 109/L, Hemoglobin \> 9.0 g/dL (+ transfusion if needed,Platelets \> 50 x 109/L,Bilirubin \< 3 x N, ALT \& AST \< 10 x N, Creatinine \< 2.0 mg/dL, Clearance \> 25 mL/min (Cockcroft and Gault formula), Prothrombin time \> 70 %, Kaolin cephalin coagulation time \< 1.5 x N. * Women of childbearing potential, must take adequate birth control measure during the study period and must have a negative pregnancy test (BetaHCG serum) * The subjects must perform all evaluations of pre-inclusion, as provided by the protocol * Signed written inform consent Exclusion Criteria: * CSF circulation disorders suspected on MRI brain (obstructive hydrocephalus) or medullar (obstacle) with, in case of a focal radiotherapy on obstructive lesion, checking the restoration of transit traffic by isotope CSF * Anti-coagulant effective dose treatment when trastuzumab administration by lumbar puncture * Patient on Lapatinib (wash out\> 2 weeks from the date of first dose intrathecal trastuzumab) * Known or suspected trastuzumab allergy * Contraindications of trastuzumab administration, including cardiac diseases: LVEF \<laboratory lower limit of normal or any other heart condition which would expose the subject to an unreasonable risk if he were to participate in the study * Severe toxicity unresolved or unstable related to another previous study restricted drug and / or a cancer treatment * Ventriculoperitoneal or atrial shunting excepted if the valve could be turn off (on-off switch) and the patient can stand it during 6 h after each injection of trastuzumab * Dementia, altered mental status or psychiatric condition that would prevent the subject to understand or give informed consent * Pre-existing severe cerebrovascular disease, such as stroke in a major vessel, vasculitis in the central nervous system or malignant hypertension * Uncontrolled infection * Participation in a clinical study with an experimental molecule * No affiliation to a Social insurance (beneficiary or assignee) * Pregnant women, breastfeeding or of childbearing age not taking contraceptive * Subject unable to make follow up schedule * Persons deprived of liberty or under guardianship (including curators)
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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.
Contacts and locations
Locations
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CHU Grenoble
Grenoble, 38700, France
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François Baclesse Center
Caen, Calvados, 14076, France
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Institut Bergonié
Bordeaux, 33076, France
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Institut Curie - Claudius Regaud Hospital
Paris, Île-de-France Region, 75248, France
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Institut Univesitaire du Cancer de Toulouse
Toulouse, 31100, France
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Institut du Cancer de Montpellier
Montpellier, 34298, France
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Léon Bérard Center
Lyon, Rhone, 69373, France
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Oscar Lambret Center
Lille, Nord, 59020, France
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Pitie Salpetriere Hospital
Paris, Île-de-France Region, 75651, France
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Rene Huguenin Hospital
Saint-Cloud, Haut de Seine, 92210, France
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Other studies related to the condition(s) this trial covers.
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- Zapping a few growing tumors may keep breast cancer drugs working longer
- Can a Two-Drug combo outsmart resistant breast and ovarian cancers?
- Can a platform trial match the right drug combo to each tumor?
- Can a vaccine teach the immune system to fight HER2-Positive tumors?