Actively Recruiting
Clinical Outcome and Quality of Life of Intrathecal Chemotherapy Through Ommaya Reservoir in Combination With Systematic Chemotherapy Versus Systematic Chemotherapy Upon Her-2 Negative Breast Cancer With Leptomeningeal Metastasis (CONQUER)
Led by Fudan University · Updated on 2025-11-25
37
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical effectiveness and quality of life impact of intrathecal chemotherapy delivered through an Ommaya reservoir combined with systemic chemotherapy versus systemic chemotherapy alone in patients with HER2-negative breast cancer who have leptomeningeal metastasis. This prospective, multicenter, randomized controlled, open-label clinical study aims to compare these treatment approaches in this patient group. Participants are assigned to one of two groups: one receiving intrathecal chemotherapy via an Ommaya reservoir along with systemic chemotherapy, and the other receiving systemic chemotherapy alone. The intrathecal chemotherapy drugs include methotrexate, thiotepa, cytarabine, cytarabine liposome, pemetrexed, or DS8201, with dosing cycles every 1 to 3 weeks. Systemic chemotherapy options include capecitabine, gemcitabine, vinorelbine, docetaxel, nab-paclitaxel, iribrin, DS8201, sacituzumab govitecan, or SKB264, with varied dosing schedules. During the study, participants will be regularly monitored through clinical assessments and laboratory tests to evaluate neural progression-free survival, which is measured six months after the last patient enrollment. Researchers will also assess quality of life and follow participants over time to monitor safety and treatment outcomes. The study is led by Fudan University and includes adults aged 18 years and older with confirmed HER2-negative metastatic breast cancer and leptomeningeal metastasis.
CONDITIONS
Brief Title
Intrathecal Chemotherapy Through Ommaya Reservoir Upon Her-2 Negative Breast Cancer With Leptomeningeal Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or above
- Able to understand the clinical trial purpose, benefits, risks, and provide informed consent
- Eastern Oncology Consortium (ECOG) physical status score of 3 or less
- Histologically or cytologically confirmed HER2-negative metastatic breast cancer
- Failure or intolerance to standard treatment
- Presence of leptomeningeal metastasis confirmed by cerebrospinal fluid cytology or brain MRI
- Adequate major organ function confirmed by lab tests (platelets, hemoglobin, neutrophils, creatinine, liver enzymes, bilirubin, coagulation)
- NYHA cardiac function class II or less with no significant ECG abnormalities
- Willing to comply with trial protocol and follow-up
- Women of childbearing age and fertile men or their partners must use effective contraception and have negative pregnancy tests before enrollment
- Recovered from non-hematological toxicity from prior treatments to mild or no symptoms as determined by investigator
You will not qualify if you...
- Pregnant or breastfeeding women
- Acute or chronic infections or other serious concurrent diseases
- Other malignancies within 5 years except certain cured cancers
- Mental illness or poor compliance affecting treatment cooperation
- Serious organ diseases or failure preventing treatment tolerance
- Bleeding disorders
- History of organ transplant
- Long-term use of corticosteroids or immunosuppressants
- Intracranial hemorrhage unrelated to tumor
- Central nervous system complications requiring urgent treatment
- Inability to collect cerebrospinal fluid (CSF) for test group
- Immunodeficiency diseases including HIV positive
- Active viral hepatitis B or C not controlled
- Serious cardiovascular diseases or symptoms including heart failure, unstable angina, recent myocardial infarction, malignant arrhythmias, prolonged QTcF, or uncontrolled high blood pressure
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Ongoing cycles every 1 to 3 weeks as determined by treatment regimen
Participants receive intrathecal chemotherapy through an Ommaya reservoir combined with systematic chemotherapy or systematic chemotherapy alone as part of their treatment.
Visits correspond to chemotherapy administration schedules, typically every 1 to 3 weeks depending on drugs used
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center; Department of Oncology, Shanghai Medical College, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
J
Jian Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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