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Sacituzumab Govitecan and Intrathecal Chemotherapy for Treating Leptomeningeal Metastases From Her2-negative Breast Cancer

RecruitingPhase 1, Phase 2Ages 18 Years - 75 YearsAllGuangzhou Medical University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 18 years old. Exclusion Criteria: 1. Inadequate organ function: 1) Blood tests: ANC โ‰ค 1.5 x 10\^9/L, PLT โ‰ค 90 x 10\^9/L, Hb โ‰ค 90 g/L; 2) Blood biochemistry tests: TBIL โ‰ฅ 1.5 times the upper limit of normal; 3) ALT and AST โ‰ฅ 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.
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What it tests

  • Sacituzumab Govitecan
  • Pemetrexed
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Where

1 site
The Affiliated Huizhou Hospital, Guangzhou Medical University
Huizhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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