Actively Recruiting
Sacituzumab Govitecan and Intrathecal Chemotherapy for Treating Leptomeningeal Metastases From Her2-negative Breast Cancer
Led by Guangzhou Medical University · Updated on 2025-09-29
34
Participants Needed
1
Research Sites
75 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Leptomeningeal metastases (LM) is a lethal complication of malignant tumors, characterized by tumor cell invasion and proliferation within the subarachnoid space. LM from HER2-negative breast cancer remains challenging to treat, with a median overall survival of only 3-6 months despite aggressive therapy. This open-label, uncontrolled Phase I/II clinical study aims to evaluate the safety, feasibility, and potential efficacy of Sacituzumab Govitecan in combination with intrathecal pemetrexed chemotherapy for LM from HER2-negative breast cancer, with the objective of identifying a more effective treatment strategy.
CONDITIONS
Official Title
Sacituzumab Govitecan and Intrathecal Chemotherapy for Treating Leptomeningeal Metastases From Her2-negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A clear histopathologic diagnosis of breast cancer with HER2-negative subtype (including IHC 0, IHC 1+ or IHC 2+ and ISH negative)
- Cerebrospinal fluid cytology confirms leptomeningeal metastases; or imaging with clinical symptoms consistent with leptomeningeal metastases
- Age 18 years or older
You will not qualify if you...
- Low blood counts: ANC less than or equal to 1.5 x 10^9/L, platelets less than or equal to 90 x 10^9/L, hemoglobin less than or equal to 90 g/L
- Blood biochemistry: total bilirubin 1.5 times or more above normal, ALT and AST 2.5 times or more above normal
- Serious or uncontrolled other medical conditions including allergies to study drugs, history of immunodeficiency, or severe diseases
- Pregnant or breastfeeding female patients; women of childbearing age unwilling or unable to use effective contraception
- Any other condition the investigator judges as making the patient unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Affiliated Huizhou Hospital, Guangzhou Medical University
Huizhou, Guangdong, China, 516000
Actively Recruiting
Research Team
Z
Zhenyu Pan
CONTACT
G
Guozi Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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