Efficacy and Safety of Intrathecal Administration of Thiotepa in Combination With Methotrexate in Breast Cancer With Leptomeningeal Metastasis
NCT Number: NCT06543992
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Leptomeningeal Metastasis of Breast Cancer
Interventions: DRUG: Intrathecal Administration of Thiotepa in Combination with Methotrexate via the Ommaya Reservoir
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Collaborators: The Affiliated Brain Hospital of Nanjing Medical University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 22
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-13
Completion Date: 2026-12-13
Locations: Jiangsu Provincial People's Hospital, Nanjing, Jiangsu, 210000, China

Summary:
Evaluate the efficacy and safety of Intrathecal Administration of Thiotepa in Combination with Methotrexate via the Ommaya Reservoir in Breast Cancer with Leptomeningeal Metastasis

Primary Outcome Measures: 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
Secondary Outcome Measures: 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|Intracranial Duration of Response, Intracranial duration of response (iDoR) is defined as the time from randomization to disease progression or death in patients who achieve complete or partial response, 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|Overall Response Rate, Overall response rate (ORR) 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 RECIST 1.1., 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|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|Duration of Response, Duration of response (DoR) is defined as the time from randomization to disease progression or death in patients who achieve complete or partial response, as per local review and according to RECIST 1.1., 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 v4.0, 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