NCT07263425 Efficacy and Safety of Intrathecal Administration of Thiotepa in Combination With Trastuzumab in Breast Cancer With Leptomeningeal Metastasis
| NCT ID | NCT07263425 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Condition | Leptomeningeal Metastasis of HER2-positive Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 26 participants |
| Start Date | 2025-10-27 |
| Primary Completion | 2027-10-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 26 participants in total. It began in 2025-10-27 with a primary completion date of 2027-10-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Evaluate the efficacy and safety of Intrathecal Administration of Thiotepa in Combination with Trastuzumab via the Ommaya Reservoir in Breast Cancer with Leptomeningeal Metastasis
Eligibility Criteria
Inclusion Criteria:The subjects must meet all of the following criteria simultaneously: * Histologically or cytologically confirmed HER-2 positive breast cancer (immunohistochemistry indicates HER-2 3+ and/or fluorescence in situ hybridization indicates HER-2 gene amplification) * Diagnosed with breast cancer with leptomeningeal metastasis based on cerebrospinal fluid cytology combined with central nervous system function and brain imaging findings * The patient has an Ommaya reservoir implanted or is eligible for implantation * KPS ≥ 30 * Adequate bone marrow and liver and kidney function reserves: absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, hemoglobin ≥ 90 g/L. International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN. Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN. Total serum bilirubin ≤ 1.5 x ULN (patients with Gilbert's syndrome can be enrolled if total bilirubin \< 3 x ULN). Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN; if the patient has liver metastasis, this criterion is AST and ALT ≤ 5 x ULN. * Female, aged between 18 and 75 years old * Left ventricular ejection fraction (LVEF) \> 50% * Voluntary signing of informed consent form Exclusion Criteria: Patients meeting any of the following criteria are not eligible to be included in this study: * Subjects with other malignant tumors, excluding skin basal cell carcinoma and carcinoma in situ * Presence of severe or uncontrollable systemic diseases, including uncontrollable hypertension or active bleeding tendency * Patients judged by the investigator to be unsuitable for participation in the trial, or those with factors that may affect the patient's compliance with the protocol * Toxicity caused by previous treatment has not recovered to normal state or is grade 1 according to NCI-CTCAE 5.0 * Allergic to or with metabolic disorders to the drugs in this protocol * Pregnant or lactating women, or women with pregnancy plans during the study period and within 6 months after the last administration * Patients participating in other clinical studies simultaneously
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07263425 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Leptomeningeal Metastasis of HER2-positive Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07263425 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07263425 currently recruiting?
Yes, NCT07263425 is actively recruiting participants. Contact the research team at real.lw@163.com for enrollment information.
Where is the NCT07263425 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT07263425 clinical trial?
NCT07263425 is sponsored by The First Affiliated Hospital with Nanjing Medical University. The trial plans to enroll 26 participants.
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