About this trial
Malignant hydrothorax and ascitic fluid in advanced breast cancer often arise from metastasis to the lungs, pleura, or liver. Patients with this condition experience rapid disease progression and multidrug resistance, facing limited treatment options. Clinical guidelines offer various therapies based on molecular subtypes; however, their effectiveness can be hindered by prior treatments, patient health, and tumor evolution. Current evaluations of treatment efficacy typically take two cycles, delaying the recognition of ineffective therapies and resulting in unnecessary side effects and costs. Organoid models present a promising solution, accurately replicating tumor structure and cellular diversity compared to traditional methods. These patient-derived models facilitate improved drug sensitivity testing, leading to more personalized treatment plans. In this study, 90 patients diagnosed with metastatic breast cancer accompanied by hydrothorax and ascitic fluid will be recruited. Patient-derived organoids will be used to assess the sensitivity of chemotherapy regimens, including Doxorubicin, Carboplatin, Cyclophosphamide, and Paclitaxel, along with targeted therapies such as Herceptin and Pertuzumab.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent form and willingness to participate in the clinical study.
patients aged between 18 and 70 years old.
Confirmed metastatic breast cancer patients with hydrothorax and ascite fluid, which was verified to contain tumor cells by lab.
ECOG performance status score of 0-1.
Disqualifiers
None
Trial population
metastatic breast cancer patients with hydrothorax and ascite fluid
Trial design
Cohort
Prospective
Treatments tested in this trial
organoid drug test
Diagnostic testBefore initiating therapy, patients diagnosed with metastatic breast cancer patients with hydrothorax and ascite fluid. The hydrothorax and ascite fluid is utilized to establish organoids and conduct drug testing.
Treatment groups
Trial outcomes
Primary outcomes
Correlation between drug sensitivity test results in patient-derived organoid models and clinical outcomes. The drug sensitivity test results obtained from patient-derived organoid models will be compared with the clinical outcomes.
Secondary outcomes
The sensitivity and specificity would be checked between drug sensitivity of organoid models in predicting the efficacy of treatment.
Sponsors and contacts
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