Using Thiotepa and Methotrexate for Breast Cancer with Leptomeningeal Metastasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of administering thiotepa in combination with methotrexate through an Ommaya Reservoir for patients with breast cancer that has spread to the leptomeninges. It is a Phase 2, single-arm, multicenter study involving 22 patients who meet specific eligibility criteria. The primary endpoint is the overall response rate based on radiographic assessments, while secondary endpoints include progression-free survival and overall survival. The study aims to provide insights into the effectiveness of this treatment combination in managing leptomeningeal metastasis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient is an adult female ≥18 and ≤75 years old at the time of informed consent.
2. ECGO rating 0-3.
3. Histologically or cytologically confirmed breast cancer.
4. 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
5. Patients can be implanted or have been implanted with Ommaya reservoirs;
6. Patient must have at least one measurable lesion (according to RECIST 1.1 criteria);
7. Postmenopausal or pre/perimenopausal female patients are eligible for enrolment; pre or perimenopausal female patients must be willing to receive LHRHa during the study period.
8. All patients were required to meet the following laboratory biochemical values prior to enrolment:

   * Haematology: Hb ≥90 g/L, WBC ≥3.5×109/L, ANC ≥1.5×109/L, PLT ≥100×109/L;
   * Liver function: for those without liver metastases, AST, ALT, ALP ≤2.5 times the upper limit of normal values, and ≤1.25 x the upper limit of normal values for total bilirubin; for those with liver metastases, AST, ALT, ALP ≤ 5 times the upper limit of normal value, and total bilirubin ≤ 1.5 x upper limit of normal value.

Exclusion Criteria:

1. Patients with other malignant tumors, excluding basal cell carcinoma and carcinoma in situ
2. Patients with severe or uncontrolled systemic disease, including uncontrolled hypertension or active bleeding tendency
3. The investigator considers the patient unsuitable for entry into this study.
4. Patients with toxicity from prior therapy that has not returned to normal or NCI-CTCAE grade 5.0
5. Patients who have a drug allergy or metabolic disorder to the drugs in this regimen
6. Pregnant or lactating women (women of childbearing age must have had a negative pregnancy test within 14 days prior to the first dose; if positive, pregnancy must be ruled out by ultrasound).
7. Patients who are concurrently enrolled in other clinical studies

Where it's running

• Jiangsu Provincial People's Hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Wei Li, Ph.D
• Email: real.lw@163.com
• Phone: 025-68307102

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.