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出境医 / 临床实验 / Breast Cancer Treatment Based on Organ-like Culture
Breast Cancer Treatment Based on Organ-like Culture
Study Description
Brief Summary:
Based on the breast cancer organ platform, this experiment establishes a drug sensitivity test method that is closer to the body tumor in breast cancer, provides a basis for the accurate treatment of breast cancer, and discusses the possible mechanism of breast cancer drug resistance.
| Condition or disease | Intervention/treatment |
|---|---|
| Breast Cancer Organoids | Drug: Trastuzumab Drug: Doxorubicin Hydrochloride Drug: Epirubicin hydrochloride Drug: Fluorouracil Drug: Paclitaxel Drug: Gemcitabine Drug: Cisplatin Drug: Recombinant Human Endostatin Drug: Pirarubicin hydrochloride Drug: Pyrrolidine Drug: Ixabepilone Drug: Tamoxifen citrate Drug: Vinorelbine tartrate Drug: Carboplatin Drug: Methotrexate Drug: Eribulin mesylate Drug: Toremifene citrate Drug: Anastrozole Drug: Letrozole Drug: Exemestane Drug: Fulvestrant Drug: Olaparib Drug: Bevacizumab Drug: Apatinib mesylate Drug: Pattozumab Drug: Capecitabine Drug: Ear particles Drug: Aidi Injection Drug: Cyclophosphamide |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 300 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Retrospective |
| Official Title: | Sensitivity Detection and Drug Resistance Mechanism of Breast Cancer Therapeutic Drugs Based on Organ-like Culture |
| Actual Study Start Date : | January 2, 2019 |
| Estimated Primary Completion Date : | December 15, 2021 |
| Estimated Study Completion Date : | December 15, 2021 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
| HER2+ Breast Cancer |
Drug: Trastuzumab
Trastuzumab Injection
Drug: Doxorubicin Hydrochloride Doxorubicin Hydrochloride Injection
Drug: Epirubicin hydrochloride Epirubicin hydrochloride injection
Drug: Fluorouracil Fluorouracil injection
Drug: Paclitaxel Paclitaxel injection
Drug: Gemcitabine Gemcitabine injection
Drug: Cisplatin Cisplatin injection
Drug: Recombinant Human Endostatin Recombinant Human Endostatin Injection
Drug: Pirarubicin hydrochloride Pirarubicin hydrochloride injection
Drug: Pyrrolidine Pyrrolidine tablets
Drug: Ixabepilone Ixapilone Injection
Drug: Tamoxifen citrate Tamoxifen citrate tablets
Drug: Vinorelbine tartrate Vinorelbine tartrate injection
Drug: Carboplatin Carboplatin injection
Drug: Methotrexate Methotrexate injection
Drug: Eribulin mesylate Eribulin mesylate injection
Drug: Toremifene citrate Toremifene citrate tablets
Drug: Anastrozole Anastrozole tablets
Drug: Letrozole Letrozole tablets
Drug: Exemestane Exemestane tablets
Drug: Fulvestrant Fulvestrant injection
Drug: Olaparib Olapani pill
Drug: Bevacizumab Bevacizumab injection
Drug: Apatinib mesylate Apatinib mesylate tablets
Drug: Pattozumab Pattozumab injection
Drug: Capecitabine Capecitabine tablets
Drug: Ear particles Ear particles
Drug: Aidi Injection Aidi Injection
Drug: Cyclophosphamide Cyclophosphamide injection
|
| ER+ Breast Cancer |
Drug: Trastuzumab
Trastuzumab Injection
Drug: Doxorubicin Hydrochloride Doxorubicin Hydrochloride Injection
Drug: Epirubicin hydrochloride Epirubicin hydrochloride injection
Drug: Fluorouracil Fluorouracil injection
Drug: Paclitaxel Paclitaxel injection
Drug: Gemcitabine Gemcitabine injection
Drug: Cisplatin Cisplatin injection
Drug: Recombinant Human Endostatin Recombinant Human Endostatin Injection
Drug: Pirarubicin hydrochloride Pirarubicin hydrochloride injection
Drug: Pyrrolidine Pyrrolidine tablets
Drug: Ixabepilone Ixapilone Injection
Drug: Tamoxifen citrate Tamoxifen citrate tablets
Drug: Vinorelbine tartrate Vinorelbine tartrate injection
Drug: Carboplatin Carboplatin injection
Drug: Methotrexate Methotrexate injection
Drug: Eribulin mesylate Eribulin mesylate injection
Drug: Toremifene citrate Toremifene citrate tablets
Drug: Anastrozole Anastrozole tablets
Drug: Letrozole Letrozole tablets
Drug: Exemestane Exemestane tablets
Drug: Fulvestrant Fulvestrant injection
Drug: Olaparib Olapani pill
Drug: Bevacizumab Bevacizumab injection
Drug: Apatinib mesylate Apatinib mesylate tablets
Drug: Pattozumab Pattozumab injection
Drug: Capecitabine Capecitabine tablets
Drug: Ear particles Ear particles
Drug: Aidi Injection Aidi Injection
Drug: Cyclophosphamide Cyclophosphamide injection
|
| Triple Negative Breast Cancer |
Drug: Trastuzumab
Trastuzumab Injection
Drug: Doxorubicin Hydrochloride Doxorubicin Hydrochloride Injection
Drug: Epirubicin hydrochloride Epirubicin hydrochloride injection
Drug: Fluorouracil Fluorouracil injection
Drug: Paclitaxel Paclitaxel injection
Drug: Gemcitabine Gemcitabine injection
Drug: Cisplatin Cisplatin injection
Drug: Recombinant Human Endostatin Recombinant Human Endostatin Injection
Drug: Pirarubicin hydrochloride Pirarubicin hydrochloride injection
Drug: Pyrrolidine Pyrrolidine tablets
Drug: Ixabepilone Ixapilone Injection
Drug: Tamoxifen citrate Tamoxifen citrate tablets
Drug: Vinorelbine tartrate Vinorelbine tartrate injection
Drug: Carboplatin Carboplatin injection
Drug: Methotrexate Methotrexate injection
Drug: Eribulin mesylate Eribulin mesylate injection
Drug: Toremifene citrate Toremifene citrate tablets
Drug: Anastrozole Anastrozole tablets
Drug: Letrozole Letrozole tablets
Drug: Exemestane Exemestane tablets
Drug: Fulvestrant Fulvestrant injection
Drug: Olaparib Olapani pill
Drug: Bevacizumab Bevacizumab injection
Drug: Apatinib mesylate Apatinib mesylate tablets
Drug: Pattozumab Pattozumab injection
Drug: Capecitabine Capecitabine tablets
Drug: Ear particles Ear particles
Drug: Aidi Injection Aidi Injection
Drug: Cyclophosphamide Cyclophosphamide injection
|
Outcome Measures
Primary Outcome Measures :
- Detection of cell viability [ Time Frame: 8 weeks before neoadjuvant chemotherapy ]1. The organ-like organ was assayed for cell viability using CellTiter Glo 3D reagent, and the curve was used to obtain a half-inhibitory concentration range. The dose was adjusted according to the half-inhibition concentration range to obtain an accurate half-inhibitory concentration.
Secondary Outcome Measures :
- Detection of in vitro model drug sensitivity [ Time Frame: 8 weeks before neoadjuvant chemotherapy ]2. In vitro model drug sensitivity: sensitive and insensitive
- Clinical efficacy assessment according to RECIST criteria [ Time Frame: 8 weeks before neoadjuvant chemotherapy ]Clinical efficacy evaluation according to RECIST criteria: imaging ultrasonography, histological pathology.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
With the prolongation of human life and lifestyle changes, the incidence and mortality of cancer has increased year by year. Since 2010, cancer has become the leading cause of death. Among women, the incidence of breast cancer is the highest, and it shows a growing trend, which seriously threatens women's health. Breast cancer has a high degree of tumor heterogeneity, which leads to a great difference in sensitivity to chemotherapy among affected individuals. The drug resistance after chemotherapy leads to poor prognosis. Therefore, screening for breast cancer tumor cells is sensitive to chemotherapy. Molecular level studies of drug resistance are necessary.
Criteria
Inclusion Criteria:
Patients with breast cancer and the largest tumor diameter ≥ 3cm No previous chemotherapy regimen age 18-65 years old Can obtain the tumor tissue specimens required for culture Heart, liver, kidney and bone marrow hematopoietic function is good Know and sign the informed consent form
Exclusion Criteria:
Pregnant or lactating women Also suffering from other cancer patients There are serious uncontrolled medical diseases or acute infections Those who are known to be allergic to this study drug or a variety of previous drugs The patient cannot understand the purpose of the study or disagree with the requirements of the study.
Other investigators believe that patients who are not suitable for this study group
Contacts and Locations
Locations
| China, Shaanxi | |
| JingSu | |
| Xi'an, Shaanxi, China | |
Sponsors and Collaborators
Xijing Hospital
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | March 30, 2019 | ||||
| First Posted Date | April 24, 2019 | ||||
| Last Update Posted Date | April 24, 2019 | ||||
| Actual Study Start Date | January 2, 2019 | ||||
| Estimated Primary Completion Date | December 15, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Detection of cell viability [ Time Frame: 8 weeks before neoadjuvant chemotherapy ] 1. The organ-like organ was assayed for cell viability using CellTiter Glo 3D reagent, and the curve was used to obtain a half-inhibitory concentration range. The dose was adjusted according to the half-inhibition concentration range to obtain an accurate half-inhibitory concentration.
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
|
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Breast Cancer Treatment Based on Organ-like Culture | ||||
| Official Title | Sensitivity Detection and Drug Resistance Mechanism of Breast Cancer Therapeutic Drugs Based on Organ-like Culture | ||||
| Brief Summary | Based on the breast cancer organ platform, this experiment establishes a drug sensitivity test method that is closer to the body tumor in breast cancer, provides a basis for the accurate treatment of breast cancer, and discusses the possible mechanism of breast cancer drug resistance. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Only Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | With the prolongation of human life and lifestyle changes, the incidence and mortality of cancer has increased year by year. Since 2010, cancer has become the leading cause of death. Among women, the incidence of breast cancer is the highest, and it shows a growing trend, which seriously threatens women's health. Breast cancer has a high degree of tumor heterogeneity, which leads to a great difference in sensitivity to chemotherapy among affected individuals. The drug resistance after chemotherapy leads to poor prognosis. Therefore, screening for breast cancer tumor cells is sensitive to chemotherapy. Molecular level studies of drug resistance are necessary. | ||||
| Condition | Breast Cancer Organoids | ||||
| Intervention |
|
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Enrolling by invitation | ||||
| Estimated Enrollment |
300 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 15, 2021 | ||||
| Estimated Primary Completion Date | December 15, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria: Patients with breast cancer and the largest tumor diameter ≥ 3cm No previous chemotherapy regimen age 18-65 years old Can obtain the tumor tissue specimens required for culture Heart, liver, kidney and bone marrow hematopoietic function is good Know and sign the informed consent form Exclusion Criteria: Pregnant or lactating women Also suffering from other cancer patients There are serious uncontrolled medical diseases or acute infections Those who are known to be allergic to this study drug or a variety of previous drugs The patient cannot understand the purpose of the study or disagree with the requirements of the study. Other investigators believe that patients who are not suitable for this study group |
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| Sex/Gender |
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| Ages | 18 Years to 65 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03925233 | ||||
| Other Study ID Numbers | KY20182079-F-1 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Xijing Hospital | ||||
| Study Sponsor | Xijing Hospital | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Xijing Hospital | ||||
| Verification Date | March 2019 | ||||
