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Trial Title:
Clinical Treatment of Refractory Breast Cancer Based on Organoid Drug Sensitivity Results
NCT ID:
NCT06438055
Condition:
Refractory Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Chemotherapy and targeted-therapy guided by organoid drug sensitivity test
Description:
This study conducts drug sensitivity tests on various clinically approved drugs. The most
sensitive drug for the patient is selected for treatment. This study aims to evaluate the
clinical effectiveness of treatment plans guided by organoid drug sensitivity tests.
Arm group label:
Organoid-Guided therapy
Summary:
This study aims to enroll refractory breast cancer patients. Patient-derived organoid
will be established, and drug sensitivity test will be conducted to intervene in the
selection of clinical treatment plans. Efficacy evaluation and prognosis analysis will
also be conducted. It is hoped that this study will provide a basis for the development
of personalized treatment plans.
Detailed description:
Forty patients with refractory breast cancer who met the inclusion criteria were enrolled
in the study after signing an informed consent form. Tumor samples were obtained through
clinical puncture, and qualified samples were subjected to organoid modeling. Perform
drug sensitivity test on the established breast cancer organoids. The drugs used are all
that have been marketed and applied in clinical practice. According to the results of
organoid drug sensitivity analysis, the patient received a treatment plan with relatively
sensitive drugs. Follow up prognostic data and relevant clinical information of enrolled
patients, conduct statistical analysis on the consistency between drug sensitivity test
results and patient treatment response, and evaluate the clinical effectiveness of
treatment plans guided by organoid drug sensitivity results.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Female, aged ≥ 18 years and ≤ 75 years old;
2. Breast cancer confirmed by histology or cytology;
3. One of the following two conditions shall be met: a) Operable breast cancer:
Recurrent progression during adjuvant therapy; or the time from initial treatment to
the onset of disease progression is less than or equal to 2 years; b) Non-operable
breast cancer: patients who have changed two line treatment plans within 6 months;
4. Being able to obtain sufficient fresh tissue specimens for organoid establishment
through puncture;
5. Expected survival time ≥ 3 months;
6. The patient voluntarily joined this study and signed an informed consent form (ICF),
with good compliance and cooperation in follow-up.
Exclusion Criteria:
1. Pregnant and lactating women;
2. Patients who have clinically significant (i.e. active) heart disease (such as
congestive heart failure, symptomatic coronary artery disease, arrhythmia, etc.) or
myocardial infarction within the past 12 months;
3. Individuals with a history of abuse of psychotropic drugs who are unable to quit or
have mental disorders;
4. The researchers believe that patients are not suitable for inclusion.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
June 2024
Completion date:
June 2026
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Collaborator:
Agency:
Kingbio Medical (Beijing) Co., Ltd.
Agency class:
Other
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06438055
