Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT04290793
Status:
UNKNOWN
Last Update Posted:
2020-03-02
First Post:
2020-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER-2+ 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': 'C000622954', 'term': 'pyrotinib'}, {'id': 'D015251', 'term': 'Epirubicin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D000068878', 'term': 'Trastuzumab'}], 'ancestors': [{'id': 'D004317', 'term': 'Doxorubicin'}, {'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': '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'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-27', 'studyFirstSubmitDate': '2020-02-27', 'studyFirstSubmitQcDate': '2020-02-27', 'lastUpdatePostDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological Complete Response rate(pCR)', 'timeFrame': 'within 3 weeks after surgery', 'description': 'pathological complete response'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate(ORR)', 'timeFrame': '2 years', 'description': 'Baseline to measured stable disease'}, {'measure': 'Event Free Survival(EFS)', 'timeFrame': '3 years', 'description': 'Baseline to the occurrence of any event'}, {'measure': 'Disease-free survival(DFS) Baseline to measured date of recurrence or death from any cause', 'timeFrame': '3 years', 'description': 'Baseline to measured date of recurrence or death from any cause'}, {'measure': 'Overall survival (OS)', 'timeFrame': '5 years', 'description': 'Baseline to measured date of death from any cause'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a prospective, open label, parallel controlled study to evaluate the efficacy and safety of neoadjuvant pyrotinib in HER2+ breast cancer patients'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female breast cancer patients at the age of \\>= 18 years and \\<= 65 years who received first treatment；\n2. Pathologically confirmed HER2-positive invasive breast cancer（which is defined as the immunohistochemistry score of \\> 10% immunoreactive cells being 3+ or in situ hybridization results showing HER2 gene amplification），regardless of hormone receptor status (ER and PR)；\n3. According to the 2019 CSCO BC guidelines: When HER-2 positive is used as the standard for preoperative neoadjuvant therapy for breast cancer, the tumor is larger than 2 cm；\n4. The Eastern Tumor Collaborative Group (ECOG) has a physical status score of ≤1；\n5. The functional level of the main organs must meet the following requirements ： 1) blood routine test: hemoglobin (Hb) ≥ 90g/L;Neutrophils (ANC) ≥ 1.5 × 10\\^9/L; platelet count (PLT) ≥ 90 × 10\\^9/L; 2) Blood biochemistry: Total bilirubin (TBIL) ≤ 1.5 upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; Urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; 3) Heart color ultrasound: Left ventricular ejection fraction (LVEF) ≥ 55%;\n6. Women of childbearing age, tested negative for serum pregnancy test 7 days before randomization，and willing to use appropriate methods during the trial and within 8 weeks after the last administration of the test drug;\n7. A volunteer to participate in the study; provision of written informed consent; good compliance and willing to cooperate during the follow-up.\n\nExclusion Criteria:\n\n1. Known history of hypersensitivity to pyrotinib or any of it components;\n2. Patients have previously received antitumor treatment or radiation therapy for any malignant tumor (except for cervical carcinoma in situ and basal cell carcinoma that have been cured);\n3. Patients underwent major breast cancer-free surgery within 4 weeks and have not fully recovered;\n4. Subjects that are unable to swallow tablets,intestinal obstruction or dysfunction of gastrointestinal absorption;\n5. Patients with severe heart disease or discomfort who cannot be treated;\n6. The patient suffers from mental illness or psychotropic substance abuse and cannot cooperate;\n7. Pregnant or lactating women;\n8. Less than 4 weeks from the last clinical trial;\n9. Patients participating in other clinical trials at the same time\n10. The researchers think inappropriate.'}, 'identificationModule': {'nctId': 'NCT04290793', 'briefTitle': 'Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER-2+ Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hebei Medical University Fourth Hospital'}, 'officialTitle': 'Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER2+Breast Cancer: a Multicenter, Randomized, Open-label, Parallel-Group Controlled Trial', 'orgStudyIdInfo': {'id': 'HRHB-CB001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Patients will receive the test drug (Pyrotinib) combined with Epirubicin and Cyclophosphamide followed by Taxanes and Trastuzumab', 'interventionNames': ['Drug: Pyrotinib', 'Drug: Epirubicin', 'Drug: Cyclophosphamide', 'Drug: Taxanes', 'Biological: Trastuzumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Patients will only receive Epirubicin and Cyclophosphamide followed by Taxanes and Trastuzumab', 'interventionNames': ['Drug: Epirubicin', 'Drug: Cyclophosphamide', 'Drug: Taxanes', 'Biological: Trastuzumab']}], 'interventions': [{'name': 'Pyrotinib', 'type': 'DRUG', 'description': '400mg administered as continuous oral once daily from the first day of the study', 'armGroupLabels': ['Experimental group']}, {'name': 'Epirubicin', 'type': 'DRUG', 'description': '90mg/m\\^2 d1 iv Q2W for 4 cycles', 'armGroupLabels': ['Control group', 'Experimental group']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': '600 mg/m\\^2 d1 iv Q2W for 4 cycles', 'armGroupLabels': ['Control group', 'Experimental group']}, {'name': 'Taxanes', 'type': 'DRUG', 'description': 'Albumin paclitaxel（125mg/m2 d1、8 iv Q3W for 4 Cycles）/Docetaxel(100mg/m2 d1 iv Q3W for 4 Cycles )', 'armGroupLabels': ['Control group', 'Experimental group']}, {'name': 'Trastuzumab', 'type': 'BIOLOGICAL', 'description': 'the first cycle is a loading dose of 8 mg / kg, followed by 6 mg / kg. Iv Q3W for 1 year', 'armGroupLabels': ['Control group', 'Experimental group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'YUNJIANG LIU, PHD.', 'role': 'CONTACT', 'email': 'lyj818326@126.com', 'phone': '86095588'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hebei Medical University Fourth Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Liu Yunjiang', 'investigatorAffiliation': 'Hebei Medical University Fourth Hospital'}}}}