Clinical trial Recruiting at 3 sites Observational Ages 18 to 70

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.

More Breast Cancer Metastatic trials

Quick facts

Study typeObservational
Ages18 Years to 70 Years
SexAll
Enrollment90 (estimated)
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine
Academic / other
Drugs / interventionschemotherapy, Pertuzumab, Cyclophosphamide, Doxorubicin
Locations3 sites (Hangzhou, Zhejiang and 2 other locations)
StatusRecruiting
StartedNovember 9, 2024
Main results expectedOctober 25, 2026
Study endsOctober 25, 2027
Registry record updatedJanuary 7, 2025
Trial IDNCT06658080 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.