Drug Sensitivity of Hydrothorax and Ascite Organoids from Breast Cancer

NCT06658080 | Recruiting

• 1 other identifier: 2024-0866
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Cancer Metastatic; Hydrothorax; Ascites; Organoids; Drug Evaluation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The sensitivity and specificity would be checked between drug sensitivity of organoid models in predicting the efficacy of treatment.

  2024.10-2026.10

Interventions

organoid drug test DIAGNOSTIC_TEST

Before initiating therapy, patients diagnosed with metastatic breast cancer patients with hydrothorax and ascite fluid. The hydrothorax and ascite fluid is utilized to establish organoids and conduct drug testing.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

metastatic breast cancer patients with hydrothorax and ascite fluid

You may qualify if:

• Signed informed consent form and willingness to participate in the clinical study.
• patients aged between 18 and 70 years old.
• Confirmed metastatic breast cancer patients with hydrothorax and ascite fluid, which was verified to contain tumor cells by lab.
• ECOG performance status score of 0-1.
• 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).

You may not qualify if:

• Patients not suitable for chemotherapy and target therapy

Sponsors & Collaborators

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

Study Sites (3)

Second affiliated hospital of zhejiang university

Hangzhou, Zhejiang, 310000, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Hydrothorax; Ascites

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

ZHIGANG CHEN, MD

CONTACT

+8657189713716; chenzg@zju.edu.cn

JIAN HUANG, MD

CONTACT

+8657189713716; drhuangjian@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 26, 2024
• Study Start: November 9, 2024
• Primary Completion (Estimated): October 25, 2026
• Study Completion (Estimated): October 25, 2027
• Last Updated: January 7, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)