Evaluating drug sensitivity in organoids from breast cancer patients with fluid buildup
Official title: Drug Sensitivity Based on Hydrothorax and Ascite Organoids Derived from Metastasic Breast Cancer
Run by Second Affiliated Hospital, Zhejiang University, School of Medicine · NCT06658080 · Data updated 2026-11-12
This study is testing how well standard chemotherapy drugs work on lab-grown samples from breast cancer patients with fluid buildup to help personalize their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine Academic / other |
| Drugs / interventions | chemotherapy, Pertuzumab, Cyclophosphamide, Doxorubicin |
| Locations | 3 sites (Hangzhou, Zhejiang and 2 other locations) |
| Status | Recruiting |
| Started | November 9, 2024 |
| Main results expected | October 25, 2026 |
| Study ends | October 25, 2027 |
| Registry record updated | January 7, 2025 |
| Trial ID | NCT06658080 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 to 70 with confirmed metastatic breast cancer and hydrothorax or ascitic fluid containing tumor cells.
✕Probably not a fit
Patients who are not suitable for chemotherapy or targeted therapy will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to recruit 90 patients diagnosed with metastatic breast cancer who also have hydrothorax and ascitic fluid. It will collect baseline medical data and tumor samples from these patients to create patient-derived organoids (PDOs). The PDOs will be tested with standard chemotherapy drugs to assess their drug sensitivity, and the results will be correlated with actual clinical outcomes using RECIST criteria. This approach seeks to personalize treatment plans and improve the efficacy of therapies for these patients.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment options for patients with metastatic breast cancer and associated fluid buildup.
How similar studies have gone: While the use of organoids for drug sensitivity testing is a promising approach, this specific application in metastatic breast cancer with hydrothorax and ascites is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Second affiliated hospital of zhejiang university
Hangzhou, Zhejiang, China Recruiting -
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China Recruiting -
2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Zhigang Chen, Md
- Email: chenzg@zju.edu.cn
- Phone: +8657189713716
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.