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| Name | Class |
|---|---|
| Kingbio Medical (Beijing) Co., Ltd. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Organoid-Guided therapy | Experimental | All patients will be included in a single-arm. Participants will undergo biopsy of tumor tissue for subsequent organoid generation and drug sensitivity tests. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy and targeted-therapy guided by organoid drug sensitivity test | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1-2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progressive free survival | The time from initiation of treatment to the occurrence of disease progression or death. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yehui Shi, PhD | Contact | +8618622221183 | shiyehui@tjmuch.com |
| Name | Affiliation | Role |
|---|---|---|
| Yehui Shi, PhD | Tianjin Cancer Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33734139 | Background | Cao W, Chen HD, Yu YW, Li N, Chen WQ. Changing profiles of cancer burden worldwide and in China: a secondary analysis of the global cancer statistics 2020. Chin Med J (Engl). 2021 Mar 17;134(7):783-791. doi: 10.1097/CM9.0000000000001474. | |
| 34002584 | Background | Lei S, Zheng R, Zhang S, Chen R, Wang S, Sun K, Zeng H, Wei W, He J. Breast cancer incidence and mortality in women in China: temporal trends and projections to 2030. Cancer Biol Med. 2021 May 18;18(3):900-9. doi: 10.20892/j.issn.2095-3941.2020.0523. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| 2 years |
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| D017437 |
| Skin and Connective Tissue Diseases |