Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-03-06 @ 10:09 PM
Study NCT ID:
NCT03925233
Status:
UNKNOWN
Last Update Posted:
2019-04-24
First Post:
2019-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breast Cancer Treatment Based on Organ-like Culture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D015251', 'term': 'Epirubicin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D043169', 'term': 'Endostatins'}, {'id': 'C027260', 'term': 'pirarubicin'}, {'id': 'C032519', 'term': 'pyrrolidine'}, {'id': 'C430592', 'term': 'ixabepilone'}, {'id': 'D013629', 'term': 'Tamoxifen'}, {'id': 'D000077235', 'term': 'Vinorelbine'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'C490954', 'term': 'eribulin'}, {'id': 'D017312', 'term': 'Toremifene'}, {'id': 'D000077384', 'term': 'Anastrozole'}, {'id': 'D000077289', 'term': 'Letrozole'}, {'id': 'C056516', 'term': 'exemestane'}, {'id': 'D000077267', 'term': 'Fulvestrant'}, {'id': 'C531550', 'term': 'olaparib'}, {'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'C553458', 'term': 'apatinib'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D043165', 'term': 'Angiostatic Proteins'}, {'id': 'D042501', 'term': 'Angiogenic Proteins'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D043170', 'term': 'Collagen Type XVIII'}, {'id': 'D024041', 'term': 'Non-Fibrillar Collagens'}, {'id': 'D003094', 'term': 'Collagen'}, {'id': 'D016326', 'term': 'Extracellular Matrix Proteins'}, {'id': 'D012596', 'term': 'Scleroproteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2021-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-23', 'studyFirstSubmitDate': '2019-03-30', 'studyFirstSubmitQcDate': '2019-04-23', 'lastUpdatePostDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of cell viability', 'timeFrame': '8 weeks before neoadjuvant chemotherapy', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Detection of in vitro model drug sensitivity', 'timeFrame': '8 weeks before neoadjuvant chemotherapy', 'description': '2\\. In vitro model drug sensitivity: sensitive and insensitive'}, {'measure': 'Clinical efficacy assessment according to RECIST criteria', 'timeFrame': '8 weeks before neoadjuvant chemotherapy', 'description': 'Clinical efficacy evaluation according to RECIST criteria: imaging ultrasonography, histological pathology.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug sensitivity experiment', 'Resistance mechanism research'], 'conditions': ['Breast Cancer Organoids']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "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.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients 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\n\nExclusion Criteria:\n\nPregnant 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.\n\nOther investigators believe that patients who are not suitable for this study group'}, 'identificationModule': {'nctId': 'NCT03925233', 'briefTitle': 'Breast Cancer Treatment Based on Organ-like Culture', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Sensitivity Detection and Drug Resistance Mechanism of Breast Cancer Therapeutic Drugs Based on Organ-like Culture', 'orgStudyIdInfo': {'id': 'KY20182079-F-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HER2+ Breast Cancer', 'interventionNames': ['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']}, {'label': 'ER+ Breast Cancer', 'interventionNames': ['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']}, {'label': 'Triple Negative Breast Cancer', 'interventionNames': ['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']}], 'interventions': [{'name': 'Trastuzumab', 'type': 'DRUG', 'description': 'Trastuzumab Injection', 'armGroupLabels': ['ER+ Breast Cancer', 'HER2+ Breast Cancer', 'Triple Negative Breast Cancer']}, {'name': 'Doxorubicin Hydrochloride', 'type': 'DRUG', 'description': 'Doxorubicin Hydrochloride Injection', 'armGroupLabels': ['ER+ Breast Cancer', 'HER2+ Breast Cancer', 'Triple Negative Breast Cancer']}, {'name': 'Epirubicin hydrochloride', 'type': 'DRUG', 'description': 'Epirubicin hydrochloride injection', 'armGroupLabels': ['ER+ Breast Cancer', 'HER2+ Breast Cancer', 'Triple Negative Breast Cancer']}, {'name': 'Fluorouracil', 'type': 'DRUG', 'description': 'Fluorouracil injection', 'armGroupLabels': ['ER+ Breast Cancer', 'HER2+ Breast Cancer', 'Triple Negative Breast Cancer']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'Paclitaxel injection', 'armGroupLabels': ['ER+ Breast Cancer', 'HER2+ Breast Cancer', 'Triple Negative Breast Cancer']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': 'Gemcitabine injection', 'armGroupLabels': ['ER+ Breast Cancer', 'HER2+ Breast Cancer', 'Triple Negative Breast Cancer']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Cisplatin injection', 'armGroupLabels': ['ER+ Breast Cancer', 'HER2+ Breast Cancer', 'Triple Negative Breast Cancer']}, {'name': 'Recombinant Human Endostatin', 'type': 'DRUG', 'description': 'Recombinant Human Endostatin Injection', 'armGroupLabels': ['ER+ Breast Cancer', 'HER2+ Breast Cancer', 'Triple Negative Breast Cancer']}, {'name': 'Pirarubicin hydrochloride', 'type': 'DRUG', 'description': 'Pirarubicin hydrochloride injection', 'armGroupLabels': ['ER+ Breast Cancer', 'HER2+ Breast Cancer', 'Triple Negative Breast Cancer']}, {'name': 'Pyrrolidine', 'type': 'DRUG', 'description': 'Pyrrolidine tablets', 'armGroupLabels': ['ER+ Breast Cancer', 'HER2+ Breast Cancer', 'Triple Negative Breast Cancer']}, {'name': 'Ixabepilone', 'type': 'DRUG', 'description': 'Ixapilone Injection', 'armGroupLabels': ['ER+ Breast Cancer', 'HER2+ Breast Cancer', 'Triple Negative Breast Cancer']}, {'name': 'Tamoxifen citrate', 'type': 'DRUG', 'description': 'Tamoxifen citrate tablets', 'armGroupLabels': ['ER+ Breast Cancer', 'HER2+ Breast Cancer', 'Triple Negative Breast Cancer']}, {'name': 'Vinorelbine tartrate', 'type': 'DRUG', 'description': 'Vinorelbine tartrate injection', 'armGroupLabels': ['ER+ Breast Cancer', 'HER2+ Breast Cancer', 'Triple Negative Breast Cancer']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Carboplatin injection', 'armGroupLabels': ['ER+ Breast Cancer', 'HER2+ Breast Cancer', 'Triple Negative Breast Cancer']}, {'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Methotrexate injection', 'armGroupLabels': ['ER+ Breast Cancer', 'HER2+ Breast Cancer', 'Triple Negative Breast Cancer']}, {'name': 'Eribulin mesylate', 'type': 'DRUG', 'description': 'Eribulin mesylate injection', 'armGroupLabels': ['ER+ Breast Cancer', 'HER2+ Breast Cancer', 'Triple Negative Breast Cancer']}, {'name': 'Toremifene citrate', 'type': 'DRUG', 'description': 'Toremifene citrate tablets', 'armGroupLabels': ['ER+ Breast Cancer', 'HER2+ Breast Cancer', 'Triple Negative Breast Cancer']}, {'name': 'Anastrozole', 'type': 'DRUG', 'description': 'Anastrozole tablets', 'armGroupLabels': ['ER+ Breast Cancer', 'HER2+ Breast Cancer', 'Triple Negative Breast Cancer']}, {'name': 'Letrozole', 'type': 'DRUG', 'description': 'Letrozole tablets', 'armGroupLabels': ['ER+ Breast Cancer', 'HER2+ Breast Cancer', 'Triple Negative Breast Cancer']}, {'name': 'Exemestane', 'type': 'DRUG', 'description': 'Exemestane tablets', 'armGroupLabels': ['ER+ Breast Cancer', 'HER2+ Breast Cancer', 'Triple Negative Breast Cancer']}, {'name': 'Fulvestrant', 'type': 'DRUG', 'description': 'Fulvestrant injection', 'armGroupLabels': ['ER+ Breast Cancer', 'HER2+ Breast Cancer', 'Triple Negative Breast Cancer']}, {'name': 'Olaparib', 'type': 'DRUG', 'description': 'Olapani pill', 'armGroupLabels': ['ER+ Breast Cancer', 'HER2+ Breast Cancer', 'Triple Negative Breast Cancer']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'description': 'Bevacizumab injection', 'armGroupLabels': ['ER+ Breast Cancer', 'HER2+ Breast Cancer', 'Triple Negative Breast Cancer']}, {'name': 'Apatinib mesylate', 'type': 'DRUG', 'description': 'Apatinib mesylate tablets', 'armGroupLabels': ['ER+ Breast Cancer', 'HER2+ Breast Cancer', 'Triple Negative Breast Cancer']}, {'name': 'Pattozumab', 'type': 'DRUG', 'description': 'Pattozumab injection', 'armGroupLabels': ['ER+ Breast Cancer', 'HER2+ Breast Cancer', 'Triple Negative Breast Cancer']}, {'name': 'Capecitabine', 'type': 'DRUG', 'description': 'Capecitabine tablets', 'armGroupLabels': ['ER+ Breast Cancer', 'HER2+ Breast Cancer', 'Triple Negative Breast Cancer']}, {'name': 'Ear particles', 'type': 'DRUG', 'description': 'Ear particles', 'armGroupLabels': ['ER+ Breast Cancer', 'HER2+ Breast Cancer', 'Triple Negative Breast Cancer']}, {'name': 'Aidi Injection', 'type': 'DRUG', 'description': 'Aidi Injection', 'armGroupLabels': ['ER+ Breast Cancer', 'HER2+ Breast Cancer', 'Triple Negative Breast Cancer']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Cyclophosphamide injection', 'armGroupLabels': ['ER+ Breast Cancer', 'HER2+ Breast Cancer', 'Triple Negative Breast Cancer']}]}, 'contactsLocationsModule': {'locations': [{'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'JingSu', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}