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| Name | Class |
|---|---|
| The Affiliated Brain Hospital of Nanjing Medical University | OTHER_GOV |
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Evaluate the efficacy and safety of Intrathecal Administration of Thiotepa in Combination with Trastuzumab via the Ommaya Reservoir in Breast Cancer with Leptomeningeal Metastasis
This was a II, single-arm, prospective, multicenter study designed to estimate the efficacy and safety of intrathecal administration of thiotepa in combination with Trastuzumab via the Ommaya Reservoir in HER2-positive breast cancer with leptomeningeal metastasis.
The primary end point was iORR [complete response (CR) + partial response (PR)] according to RANO-LM. Scoring based on radiographic assessment in leptomeningeal metastases . A composite score (total score) is calculated and compared with the baseline total score. A 25% worsening in the current score relative to baseline defines radiographic progressive disease. A 50% improvement in the current score defines a radiographic partial response. Resolution of all baseline radiographic abnormalities defines a complete response. All other situations define stable disease. The secondary end points were changes in iPFS,PFS, OS, and exploratory analysis of the relationship between molecular markers and therapeutic efficacy.
This study is planned to include 26 patients with leptomeningeal metastasis from breast cancer who meet the entry criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Intrathecal chemotherapy group Patients received intrathecal 150mg Trastuzumab combination with 10mg thiotepa once every three weeks until an event that meets the criteria for termination occurs. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrathecal Administration of Thiotepa in Combination with Trastuzumab via the Ommaya Reservoir | Drug | Intrathecal chemotherapy group Patients received intrathecal 150mg Trastuzumab combination with 10mg thiotepa once every three weeks until an event that meets the criteria for termination occurs. |
| Measure | Description | Time Frame |
|---|---|---|
| Intracranial Overall Response Rate | Intracranial overall response rate (iORR) is defined as the proportion of patients whose best overall response is either complete response (CR) or partial response (PR), as per local review and according to RANO-LM. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Measure | Description | Time Frame |
|---|---|---|
| Intracranial Progression Free Survival | Intracranial progression-free survival (iPFS) is defined as the time from the date of randomization to the date of the first documented progression, as per local review and according to RANO-LM or death due to any cause. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
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Inclusion Criteria:The subjects must meet all of the following criteria simultaneously:
Exclusion Criteria:
Patients meeting any of the following criteria are not eligible to be included in this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Li, Ph.D | Contact | 025-68307102 | real.lw@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial People's Hospital | Recruiting | Nanjing | Jiangsu | 210000 | China |
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| Progression Free Survival | Progression-free survival (PFS) is defined as the time from the date of randomization to the date of the first documented progression as per local review and according to RECIST 1.1 or death due to any cause. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Overall Survival | Overall survival is defined as the time from the date of randomization to the date of death due to any cause | From date of randomization until the date of death from any cause, assessed up to 100 months |
| frequency/severity of adverse events, lab abnormalities | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |