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Recruiting Observational

Drug Sensitivity of Hydrothorax and Ascite Organoids from Breast Cancer

NCT06658080 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2024-11-09
Last updated
2025-01-07

Condition(s) studied

Breast Cancer MetastaticHydrothoraxAscitesOrganoidsDrug Evaluation

Investigational drug(s) / intervention(s)

organoid drug test

organoid drug 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.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Signed informed consent form and willingness to participate in the clinical study. 2. patients aged between 18 and 70 years old. 3. Confirmed metastatic breast cancer patients with hydrothorax and ascite fluid, which was verified to contain tumor cells by lab. 4. ECOG performance status score of 0-1. 5. 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). Exclusion Criteria: 1.Patients not suitable for chemotherapy and target therapy

Primary outcome measure(s)

  • 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. — 2024.10-2026.10

Trial sites (3)

FacilityCityRegionStatus
Second affiliated hospital of zhejiang university Hangzhou Zhejiang Recruiting
Zhejiang Cancer Hospital Hangzhou Zhejiang Recruiting
2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China Hangzhou Zhejiang Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06658080 on ClinicalTrials.gov ↗ ← All trials in China