Drug Sensitivity of Hydrothorax and Ascite Organoids from Breast Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • organoid drug test

    Diagnostic test

    Before 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

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
2024.10-2026.10

Secondary outcomes

1

The sensitivity and specificity would be checked between drug sensitivity of organoid models in predicting the efficacy of treatment.

Time frame
2024.10-2026.10

Other outcomes

Sponsors and contacts

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