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Tests treatment safety and results for Leptomeningeal Metastasis of HER2-positive Breast Cancer
Official title Efficacy and Safety of Intrathecal Administration of Thiotepa in Combination With Trastuzumab in Breast Cancer With Leptomeningeal Metastasis
ClinicalTrials.gov ID: NCT07263425
What this study is testing
What is Intrathecal Administration of Thiotepa in Combination with Trastuzumab via the Ommaya Reservoir?
Intrathecal Administration of Thiotepa in Combination with Trastuzumab via the Ommaya Reservoir is an investigational medicine, being studied as a potential treatment for leptomeningeal metastasis of her2-positive breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Evaluate the efficacy and safety of Intrathecal Administration of Thiotepa in Combination with Trastuzumab via the Ommaya Reservoir in Breast Cancer with Leptomeningeal Metastasis
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- The people 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...
- Diagnosed with breast cancer with leptomeningeal metastasis based on cerebrospinal fluid cytology combined with central nervous system function and...
- The patient has an Ommaya reservoir implanted or is eligible for implantation
- KPS ≥ 30
You likely can't join if
- Patients meeting any of the following criteria are not eligible to be included in this study:
- people 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...
- 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
See the full eligibility criteria
- The people 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) ≤...
- Female, aged between 18 and 75 years old
- Left ventricular ejection fraction (LVEF) \> 50%
- Voluntary signing of informed consent form
- Patients meeting any of the following criteria are not eligible to be included in this study:
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.