Breast Cancer Treatment Based on Organ-like Culture
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| ClinicalTrials.gov Identifier: NCT03925233 |
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Recruitment Status :
Enrolling by invitation
First Posted : April 24, 2019
Last Update Posted : April 24, 2019
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Sponsor:
Xijing Hospital
Information provided by (Responsible Party):
Xijing Hospital
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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 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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
| 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 |
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.
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| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03925233
Locations
| China, Shaanxi | |
| JingSu | |
| Xi'an, Shaanxi, China | |
Sponsors and Collaborators
Xijing Hospital
| Responsible Party: | Xijing Hospital |
| ClinicalTrials.gov Identifier: | NCT03925233 |
| Other Study ID Numbers: |
KY20182079-F-1 |
| First Posted: | April 24, 2019 Key Record Dates |
| Last Update Posted: | April 24, 2019 |
| Last Verified: | March 2019 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Xijing Hospital:
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Drug sensitivity experiment Resistance mechanism research |
Additional relevant MeSH terms:
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Tamoxifen Toremifene Gemcitabine Vinorelbine Cyclophosphamide Bevacizumab Carboplatin Doxorubicin Liposomal doxorubicin Fluorouracil |
Capecitabine Methotrexate Trastuzumab Letrozole Apatinib Epirubicin Olaparib Fulvestrant Anastrozole Exemestane Endostatins Pirarubicin Citric Acid Sodium Citrate Antineoplastic Agents, Phytogenic |