NCT06658080 Drug Sensitivity of Hydrothorax and Ascite Organoids from Breast Cancer
| NCT ID | NCT06658080 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Breast Cancer Metastatic |
| Study Type | OBSERVATIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-11-09 |
| Primary Completion | 2026-10-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 90 participants in total. It began in 2024-11-09 with a primary completion date of 2026-10-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06658080 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Breast Cancer Metastatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06658080 currently recruiting?
Yes, NCT06658080 is actively recruiting participants. Contact the research team at chenzg@zju.edu.cn for enrollment information.
Where is the NCT06658080 trial being conducted?
This trial is being conducted at Hangzhou, China, Hangzhou, China, Hangzhou, China.
Who is sponsoring the NCT06658080 clinical trial?
NCT06658080 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 90 participants.
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