Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-03-06 @ 12:59 PM
Study NCT ID:
NCT03017404
Status:
COMPLETED
Last Update Posted:
2017-01-11
First Post:
2017-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dose Increase Finding Study of Doxorubicin Hydrochloride Liposome Injection for Patients With Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-10', 'studyFirstSubmitDate': '2017-01-09', 'studyFirstSubmitQcDate': '2017-01-10', 'lastUpdatePostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'maximum tolerated dose', 'timeFrame': '4 cycles (each cycle is 21 days) of chemotherapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'To study the maximum tolerated dose of Doxorubicin Hydrochloride Liposome Injection combination with cyclophosphamide and sequential treatment of docetaxel for patients with locally advanced breast cancer'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients newly diagnosed breast cancer≥18 and ≤70 years of age;\n* Karnofsky performance status≥70 and measurable or evaluable;\n* Stages Ⅲa-ⅢC;\n* Baseline left ventricular ejection fraction (LVEF) ≥ 50%;\n* Adequate marrow function (WBC count\\> 4.0×10(9)/L, neutrophil\\> 2.0×10(9)/L, platelet count \\> 100×10(9)/L，hemoglobin \\> 90g/L );\n* AST and ALT ≤1.5× institutional upper limit of normal, alkaline phosphatase\n* ≤2.5×institutional upper limit of normal，bilirubin ≤institutional upper limit of normal;\n* Serum creatinine ≥ 44µmol/L and ≤ 133 µmol/L;\n* Expected lifetime ≥ 12 months;\n* Pregnancy tests of reproductive age women is negative;\n* All patients provided written informed consent.\n\nExclusion Criteria:\n\n* Distant metastasis;\n* Severe heart failure (NYHA grade II or higher);\n* Active and uncontrolled severe infection;\n* Hypersensitivity to anthracycline therapy or a history of severe hypersensitivity reactions to products containing liposomal doxorubicin and docetaxel;\n* Have accepted any other anti-tumor drug within 30 days before the first dose of doxorubicin hydrochloride liposome or doxorubicin;\n* Pregnancy or breast feeding;\n* Other situations that investigators consider as contra-indication for this study'}, 'identificationModule': {'nctId': 'NCT03017404', 'briefTitle': 'A Dose Increase Finding Study of Doxorubicin Hydrochloride Liposome Injection for Patients With Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hebei Medical University Fourth Hospital'}, 'officialTitle': 'A Dose Increase Finding Study of Doxorubicin Hydrochloride Liposome Injection in Neoadjuvant Chemotherapy for Patients With Locally Advanced Breast Cancer', 'orgStudyIdInfo': {'id': 'CSPC-DMS-BC-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment group:35 mg/m(2)', 'description': 'Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy', 'interventionNames': ['Drug: Doxorubicin Hydrochloride Liposome Injection', 'Drug: Cyclophosphamide', 'Drug: docetaxel']}, {'type': 'EXPERIMENTAL', 'label': 'treatment group:40 mg/m(2)', 'description': 'Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy', 'interventionNames': ['Drug: Doxorubicin Hydrochloride Liposome Injection', 'Drug: Cyclophosphamide', 'Drug: docetaxel']}, {'type': 'EXPERIMENTAL', 'label': 'treatment group:45 mg/m(2)', 'description': 'Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy', 'interventionNames': ['Drug: Doxorubicin Hydrochloride Liposome Injection', 'Drug: Cyclophosphamide', 'Drug: docetaxel']}, {'type': 'EXPERIMENTAL', 'label': 'treatment group:50 mg/m(2)', 'description': 'Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy', 'interventionNames': ['Drug: Doxorubicin Hydrochloride Liposome Injection', 'Drug: Cyclophosphamide', 'Drug: docetaxel']}], 'interventions': [{'name': 'Doxorubicin Hydrochloride Liposome Injection', 'type': 'DRUG', 'armGroupLabels': ['treatment group:35 mg/m(2)', 'treatment group:40 mg/m(2)', 'treatment group:45 mg/m(2)', 'treatment group:50 mg/m(2)']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'armGroupLabels': ['treatment group:35 mg/m(2)', 'treatment group:40 mg/m(2)', 'treatment group:45 mg/m(2)', 'treatment group:50 mg/m(2)']}, {'name': 'docetaxel', 'type': 'DRUG', 'armGroupLabels': ['treatment group:35 mg/m(2)', 'treatment group:40 mg/m(2)', 'treatment group:45 mg/m(2)', 'treatment group:50 mg/m(2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050019', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'Fourth Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hebei Medical University Fourth Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}