Ignite Creation Date:
2024-07-17 @ 10:48 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06462092
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-12
Brief Title:
Sacituzumab Govitecan and Intrathecal Chemotherapy for Treating Leptomeningeal Metastases From Her2-negative Breast Cancer
Sponsor:
Guangzhou Medical University
Organization:
Guangzhou Medical University
Study Overview
Official Title:
A Phase III Clinical Study of Sacituzumab Govitecan Combined With Intrathecal Chemotherapy for the Treatment of Leptomeningeal Metastases From Her2-negative Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Leptomeningeal metastases is a specific pattern of central involvement in which tumor cells invade and proliferate in the subarachnoid space and is a lethal complication of malignant tumors Leptomeningeal metastases from Her2-negative breast cancer is still tricky to treat at present with an overall median survival of only 3-6 months even after aggressive treatment This study is an open uncontrolled phase III clinical study to observe the safety feasibility and potential efficacy of Sacituzumab Govitecan combined with pemetrexed intrathecal chemotherapy in the treatment of patients with Her2-negative breast cancer leptomeningeal metastases in search of a more effective treatment
Detailed Description:
This study is a single-arm prospective phase III clinical trial to observe the safety feasibility and potential efficacy of Sacituzumab Govitecan combined with pemetrexed intrathecal chemotherapy in the treatment of patients with Her2-negative breast cancer leptomeningeal metastases Patients were treated with Sacituzumab Govitecan 10mgkg infused intravenously on days 1 and 8 Treatment cycles were every 21 days and continued until disease progression or unacceptable toxicity Pemetrexed intrathecal chemotherapy was initiated on Day 2 after Sacituzumab Govitecan administration Pemetrexed intrathecal chemotherapy is administered by intracerebroventricular or lumbar puncture Pemetrexed intrathecal chemotherapy is divided into induction consolidation and maintenance phases Induction therapy was first performed with a single dose of 15 mg twice a week for 2 weeks for a total of 4 doses This was followed by consolidation therapy 1 time per week for 4 consecutive weeks for a total of 4 times Patients whose treatment was evaluated as effective were given maintenance therapy once a month until relapse or death A minimum of 3 patients and a maximum of 6 patients were recruited into the phase I cohort When dose-limiting toxicity occurred in 2 patients the treatment regimen was considered to be excessively side-effective and a reduction in the intrathecal chemotherapy dose of pemetrexed to a single 10-mg dose was given with continued enrollment of 6 consecutive patients If DLT occurred again in 2 patients the trial would be stopped Otherwise the study entered a phase II trial when DLT occurred in 1 patient
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None