An interventional study of Chemotherapy and targeted-therapy guided by organoid drug sensitivity test in Refractory Breast Cancer, sponsored by Tianjin Medical University Cancer Institute and Hospital. Not yet recruiting. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-05-31.
Sponsored by Tianjin Medical University Cancer Institute and Hospital · Not applicable, Interventional, and Treatment
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 40 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 484 studies on the registry; 286 are open to participants now.
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Exclusion Criteria:
All patients will be included in a single-arm. Participants will undergo biopsy of tumor tissue for subsequent organoid generation and drug sensitivity tests.
Other: Chemotherapy and targeted-therapy guided by organoid drug sensitivity test
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.
Objective Response Rate
Percentage of patient's measurable disease who have achieved either complete response (CR) or partial response (PR) according to RECIST 1.1.
Time frame: 1-2 years
Progressive free survival
The time from initiation of treatment to the occurrence of disease progression or death.
Time frame: 1-2 years
Overall survival time
The time from the date of randomization to the date of death for any cause. Patients will be followed until their date of death or until final database closure.
Time frame: 2 years
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Tianjin Medical University Cancer Institute and Hospital