Sacituzumab govitecan plus intrathecal pemetrexed for leptomeningeal metastases from HER2-negative breast cancer

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 single-arm Phase I/II trial gives intravenous sacituzumab govitecan (10 mg/kg on Days 1 and 8 of a 21-day cycle) together with intrathecal pemetrexed delivered via lumbar puncture or intracerebroventricular access. Intrathecal pemetrexed is administered in an induction phase (15 mg twice weekly for 2 weeks), a consolidation phase (once weekly for 4 weeks), and maintenance (once monthly for responders), with systemic therapy continued until progression or unacceptable toxicity. Phase I enrolled 3–6 patients to monitor dose-limiting toxicities and allowed a reduction of the intrathecal dose to 10 mg if toxicity thresholds were met before moving to Phase II. The trial focuses primarily on safety and feasibility with secondary evaluation of clinical and radiographic activity against leptomeningeal disease.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. A clear histopathologic diagnosis of breast cancer with HER2-negative subtype (including IHC 0, IHC 1+ or IHC 2+ and ISH negative);
2. Cerebrospinal fluid cytology confirms the presence of leptomeningeal metastases; or imaging findings combined with clinical symptoms and signs are consistent with the diagnosis of leptomeningeal metastases;
3. Age ≥ 18 years old.

Exclusion Criteria:

1. Inadequate organ function: 1) Blood tests: ANC ≤ 1.5 x 10\^9/L, PLT ≤ 90 x 10\^9/L, Hb ≤ 90 g/L; 2) Blood biochemistry tests: TBIL ≥ 1.5 times the upper limit of normal; 3) ALT and AST ≥ 2.5 times the upper limit of normal;
2. Presence of serious and/or uncontrolled comorbidities that may affect participation: 1) Allergy to study drugs or adjuvant materials; 2) History of immunodeficiency (e.g., HIV-positive or other acquired or congenital immunodeficiency disease); 3) Severe concomitant diseases;
3. Pregnant and breastfeeding female patients; women of childbearing age who are unwilling or unable to use effective contraception;
4. Any other condition that, in the opinion of the investigator, makes the patient ineligible for participation in the study.

Where it's running

• The Affiliated Huizhou Hospital, Guangzhou Medical University
  Huizhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Zhenyu Pan — Huizhou Hospital of Guangzhou Medical University
• Study coordinator: Zhenyu Pan
• Email: dr-zypan@163.com
• Phone: +8618718178286

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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.