Breast Cancer MetastaticNCT06658080
Drug Sensitivity of Hydrothorax and Ascite Organoids from Breast Cancer
An observational study of Breast Cancer Metastatic and Hydrothorax, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast Cancer Metastatic, Hydrothorax, Ascites
- What is being tested?
- organoid drug test
- How many people
- 90 participants
- Where
- 3 sitesChina
- Study dates
- 9 Nov 2024to 25 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: metastatic breast cancer patients with hydrothorax and ascite fluid
Who may be able to join
- 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).
Who cannot join
- 1.Patients not suitable for chemotherapy and target therapy
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Second affiliated hospital of zhejiang university
Hangzhou, Zhejiang, 310000
zhigang chen, MD, 13819132563, pridechen@126.com
JIAN HUANG, MD
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000
Jun Fang, MD, 8615869188981, fangjun1391@zjcc.org.cn
Jun Fang, MD
- Recruiting
2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310009
ZHIGANG CHEN, MD, +8657189713716, chenzg@zju.edu.cn
JIAN HUANG, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer Metastatic, Hydrothorax, Ascites, Organoids, Drug Evaluation
- Being tested
- organoid drug test
- Medical subject headings
- Hydrothorax, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
organoid drug testDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2024.10-2026.10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start9 Nov 2024
- Primary completion25 Oct 2026 (estimated)
- Study completion25 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658080
- Sponsor's protocol ID
- 2024-0866
- Status last verified
- Nov 2024
- First submitted
- 23 Oct 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Sensitivity Based on Hydrothorax and Ascite Organoids Derived from Metastasic Breast Cancer
- ClinicalTrials.gov ID
- NCT06658080
- Acronym / sponsor ID
- 2024-0866
- Conditions
- Breast Cancer Metastatic, Hydrothorax, Ascites, Organoids, Drug Evaluation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 9 Nov 2024 (actual)
- Primary completion
- 25 Oct 2026 (estimated)
- Study completion
- 25 Oct 2027 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- metastatic breast cancer patients with hydrothorax and ascite fluid
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (1 listed)
- 1.Patients not suitable for chemotherapy and target therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| organoid drug testBefore 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. | Diagnostic test | – |
Primary outcome
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.
Time frame: 2024.10-2026.10
1 secondary outcome
The sensitivity and specificity would be checked between drug sensitivity of organoid models in predicting the efficacy of treatment.
Time frame: 2024.10-2026.10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Metastatic and Hydrothorax, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ZHIGANG CHEN, MD (+8657189713716, chenzg@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 2024.10-2026.10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.