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Efficacy and Safety of Intrathecal Administration of Thiotepa in Combination With Methotrexate in Breast Cancer With Leptomeningeal Metastasis

ConditionLeptomeningeal Metastasis of Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient is an adult female ≥18 and ≤75 years old at the time of informed consent.

ECGO rating 0-3.

Histologically or cytologically confirmed breast cancer.

A new diagnosis of LM, established either by the presence of malignant cells in the CSF or by the combination of characteristic clinical manifestations and magnetic resonance imaging (MRI) findings

Disqualifiers

Patients with other malignant tumors, excluding basal cell carcinoma and carcinoma in situ

Patients with severe or uncontrolled systemic disease, including uncontrolled hypertension or active bleeding tendency

The investigator considers the patient unsuitable for entry into this study.

Patients with toxicity from prior therapy that has not returned to normal or NCI-CTCAE grade 5.0

Trial design

Design model

Single group

Treatments tested in this trial

  • Intrathecal Administration of Thiotepa in Combination with Methotrexate via the Ommaya Reservoir

    Drug

    Patients received 15 mg MTX intrathecally combined with 10 mg thiotepa twice a week for 2 weeks (4 injections), followed by a maintenance phase in which the same agents and dosages were administered every three weeks until an event meeting the termination criteria occurs.

Treatment groups

22 Participants
are divided into 1 treatment group
Group A: Intrathecal chemotherapy groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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 outcomes

1

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.

Time frame
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
2

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.

Time frame
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
3

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.

Time frame
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
4

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.

Time frame
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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital with Nanjing Medical University

Lead sponsor

The Affiliated Brain Hospital of Nanjing Medical University

Collaborator

Source ClinicalTrials.gov
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