Drug Sensitivity of Hydrothorax and Ascite Organoids from Breast Cancer

Drug Sensitivity Based on Hydrothorax and Ascite Organoids Derived from Metastasic Breast Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Ascites; Breast Cancer Metastatic; Organoids; Hydrothorax; Drug Evaluation
• Intervention / Treatment: Diagnostic test: organoid drug test

Detailed Description

90 metastatic breast cancer patients with hydrothorax and ascitic fluid will be recruited. Baseline data, including medical history, ultrasound, and MRI records, will be collected both before and after two cycles of chemotherapy. Tumor samples from hydrothorax and ascitic fluid will be obtained and cultured to generate patient-derived organoids (PDOs). These PDOs will then be exposed to standard chemotherapeutic drugs used in breast cancer treatment. Organoid growth will be monitored post-treatment, and dose-response curves will be generated to assess drug sensitivity. To evaluate clinical outcomes, the RECIST criteria will be applied to measure tumor response in patients. Correlation analysis will be performed to determine the consistency between the treatment responses observed in the PDO models and the actual clinical outcomes of the patients.

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: ZHIGANG CHEN, MD; Phone Number: +8657189713716; Email: chenzg@zju.edu.cn
• Study Contact Backup: Name: JIAN HUANG, MD; Phone Number: +8657189713716; Email: drhuangjian@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: Jun Fang, MD; Phone Number: 8615869188981; Email: fangjun1391@zjcc.org.cn
      • Contact: Jun Fang, MD
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
      • Contact: ZHIGANG CHEN, MD; Phone Number: +8657189713716; Email: chenzg@zju.edu.cn
      • Contact: JIAN HUANG, MD
      • Contact: ZHIGANG CHEN, MD
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Second Affiliated Hospital of Zhejiang University
      • Contact: JIAN HUANG, MD
      • Contact: ZHIGANG CHEN, MD
      • Contact: zhigang chen, MD; Phone Number: 13819132563; Email: pridechen@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

metastatic breast cancer patients with hydrothorax and ascite fluid

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
The sensitivity and specificity would be checked between drug sensitivity of organoid models in predicting the efficacy of treatment.	2024.10-2026.10

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2024
• Primary Completion (Estimated): October 25, 2026
• Study Completion (Estimated): October 25, 2027

Study Registration Dates

• First Submitted: October 23, 2024
• First Submitted That Met QC Criteria: October 23, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 5, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Skin Diseases; Breast Diseases; Pleural Diseases; Breast Neoplasms; Ascites; Hydrothorax
• Other Study ID Numbers: 2024-0866

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No