Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-01-05 @ 8:47 PM
Study NCT ID:
NCT03359694
Status:
UNKNOWN
Last Update Posted:
2017-12-02
First Post:
2017-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mutation Scores and Differential Protein Evaluating Efficacy in Adjuvant Chemotherapy in HER2(-) Luminal B Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020022', 'term': 'Genetic Predisposition to Disease'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D004198', 'term': 'Disease Susceptibility'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'C506643', 'term': 'liposomal doxorubicin'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D000077235', 'term': 'Vinorelbine'}, {'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-27', 'studyFirstSubmitDate': '2017-11-20', 'studyFirstSubmitQcDate': '2017-11-27', 'lastUpdatePostDateStruct': {'date': '2017-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pCR rate', 'timeFrame': '2 years', 'description': 'pCR rate in the DT and ET group'}], 'secondaryOutcomes': [{'measure': 'Efficacy of neo-adjuvant chemotherapy', 'timeFrame': '5 years', 'description': '5-year DFS in the DT and ET group'}, {'measure': 'Efficacy of sequential chemotherapy', 'timeFrame': '6 years', 'description': '5-year DFS of non- pCR patients treated by sequential NX regimen'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer, neoadjuvant chemotherapy,susceptible gene'], 'conditions': ['Susceptibility, Genetic', 'Chemotherapy Effect']}, 'descriptionModule': {'briefSummary': 'We plan to carry out a prospective, randomized, open phase III clinical trial which sponsored by the Tianjin Medical University Cancer Hospital and Institute. The primary aim is to evaluate pCR of DT and ET regimen as neoadjuvant chemotherapy in the treatment of HER2 negative Luminal B breast cancers and the correlation of pCR respectively with the susceptible gene mutation scores and differential protein identified by proteomics. For patients with pCR, the association between the 5 year DFS and susceptible gene mutation scores and differential protein identified by proteomics will be evaluated. All Non-pCR patients will receive NX chemotherapy for 4 cycles, and to evaluate correlations between 5 year DFS of these patients respectively with susceptible gene mutation scores and differential protein identified by proteomics, and to evaluate the safety of neoadjuvant chemotherapy and sequential adjuvant NX regimen therapy. Meanwhile, we will verify susceptible gene mutation scores and differential protein identified by proteomics are significant predictors of HER2 negative Luminal B breast cancer chemotherapy sensitivity and prognosis, and explore the feasibility of susceptible gene mutation scores and differential protein in clinical application.', 'detailedDescription': 'This is a prospective, randomized, open phase III clinical trial which will be sponsored by the Tianjin Medical University Cancer Hospital and Institute. The primary aim is to evaluate pCR of Pegylated Liposomal Doxorubicin and Docetaxel (DT) Compared to Conventional Doxorubicin and Docetaxel (ET) regimen as neoadjuvant chemotherapy in the treatment of HER2 negative Luminal B breast cancers and the correlation of pCR respectively with the susceptible gene mutation scores and differential protein identified by proteomics. For patients with pCR, the association between the 5 year DFS and susceptible gene mutation scores and differential protein identified by proteomics will be evaluated. All Non-pCR patients will receive NX chemotherapy for 4 cycles, and to evaluate correlations between 5 year DFS of these patients respectively with susceptible gene mutation scores and differential protein identified by proteomics, and to evaluate the safety of neoadjuvant chemotherapy and sequential adjuvant Nalvelbine and Xeloda (NX) regimen therapy. Meanwhile, we will verify susceptible gene mutation scores and differential protein identified by proteomics are significant predictors of HER2 negative Luminal B breast cancer chemotherapy sensitivity and prognosis, and explore the feasibility of susceptible gene mutation scores and differential protein in clinical application.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent form\n* Compliance with test procedures and good compliance\n* Females, Age more than 18 years of age, less than 70 years old\n* The ECOG score is 0-1\n* Primary invasive cancer, T2-4bN0-2M0 breast cancers\n* Neoadjuvant chemotherapy with standard 6 courses should be completed\n* Patients must undergo standard breast cancer surgery after neoadjuvant chemotherapy\n* Luminal B, Her2 negative patients\n* No other malignant tumors occurred at the same time\n* adequate liver and kidney function\n\nExclusion Criteria:\n\n* Any metastasis\n* Suffered other maligant tumors\n* Participate in other trials\n* Accompanied with severe systemic disease and / or uncontrollable infection\n* Pregnant and lactating women\n* Dysfunction of liver and kidney'}, 'identificationModule': {'nctId': 'NCT03359694', 'briefTitle': 'Mutation Scores and Differential Protein Evaluating Efficacy in Adjuvant Chemotherapy in HER2(-) Luminal B Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University Cancer Institute and Hospital'}, 'officialTitle': 'Mutation Scores and Differential Protein Evaluating Efficacy in Neo-adjuvant Chemotherapy and the Non-PCR Patients Treated With Sequential Nalvelbine and Xeloda in HER2(-) Luminal B Breast Cancer', 'orgStudyIdInfo': {'id': 'NO20170819'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DT group', 'description': 'Pegylated liposomal doxorubicin and Docetaxel Treatment group Pegylated liposomal doxorubicin 30mg/m2，iv，d1， Docetaxel 75mg/m2，iv，d1， q21d×6', 'interventionNames': ['Drug: DT group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ET group', 'description': 'Conventional doxorubicin and Docetaxel Treatment group Conventional doxorubicin 75mg/m2，iv，d1， Docetaxel 75mg/m2，iv，d1， q21d×6', 'interventionNames': ['Drug: ET group']}, {'type': 'EXPERIMENTAL', 'label': 'NX group', 'description': 'Navelbine and Xeloda treatment group in group of Non-pCR patients Navelbine IVD 25 mg/m2 D1、D8 Xeloda PO 1000 mg/m2 bid D1-D14 q21d×4', 'interventionNames': ['Drug: NX group']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'no treatment group of Non-pCR patients after DT or ET neoadjuvant chemotherapy.\n\nNo drugs treatment in this group.'}], 'interventions': [{'name': 'DT group', 'type': 'DRUG', 'otherNames': ['Pegylated liposomal doxorubicin and Docetaxel'], 'description': 'Pegylated liposomal doxorubicin 30mg/m2，iv，d1， Docetaxel 75mg/m2，iv，d1， q21d×6', 'armGroupLabels': ['DT group']}, {'name': 'ET group', 'type': 'DRUG', 'otherNames': ['Conventional doxorubicin and Docetaxel'], 'description': 'Conventional doxorubicin 75mg/m2，iv，d1， Docetaxel 75mg/m2，iv，d1， q21d×6', 'armGroupLabels': ['ET group']}, {'name': 'NX group', 'type': 'DRUG', 'otherNames': ['Navelbine and Xeloda'], 'description': 'Navelbine IVD 25 mg/m2 D1、D8 Xeloda PO 1000 mg/m2 bid D1-D14 q21d', 'armGroupLabels': ['NX group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300000', 'city': 'Tianjin', 'country': 'China', 'facility': 'Jin Zhang', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Sheng Zhang, Doctor', 'role': 'CONTACT', 'email': '403826461@qq.com', 'phone': '+86 23340123', 'phoneExt': '2111'}], 'overallOfficials': [{'name': 'Jin Zhang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tianjin Medical University Cancer Institure and Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University Cancer Institute and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}