Drug Sensitivity of Hydrothorax and Ascite Organoids from Breast Cancer

Recruiting now

Conditions studied: Breast Cancer Metastatic, Hydrothorax, Ascites, Organoids, Drug Evaluation

In brief

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.

Key facts

Study ID

NCT06658080

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

90

Starts

2024-11-09

Expected to finish

2027-10-25

Last updated by the study team

2025-01-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• No significant abnormalities in liver and kidney function (BIL <1.5-fold upper limit of normal (ULN)；ALT<2.5×ULN; AST<2.5×ULN；Crea≤1×ULN).

You may not qualify if…

• Patients not suitable for chemotherapy and target therapy

Where it is running

• Second affiliated hospital of zhejiang university — Hangzhou, Zhejiang, China (enrolling)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (enrolling)
• 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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