Evaluating drug sensitivity in organoids from breast cancer patients with fluid buildup
Drug Sensitivity Based on Hydrothorax and Ascite Organoids Derived from Metastasic Breast Cancer
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 |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy, Pertuzumab, Cyclophosphamide, Doxorubicin |
| Locations | 3 sites (Hangzhou, Zhejiang and 2 other locations) |
| Trial ID | NCT06658080 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are not suitable for chemotherapy or targeted therapy will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hangzhou, Zhejiang and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.