Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT07057427
Status:
RECRUITING
Last Update Posted:
2025-07-09
First Post:
2025-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Nab-PHP Versus TCbHP in Neoadjuvant Therapy for HER2-positive Early 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': 'D013660', 'term': 'Taxes'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'C485206', 'term': 'pertuzumab'}], 'ancestors': [{'id': 'D004467', 'term': 'Economics'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'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': 'D056831', 'term': 'Coordination Complexes'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 812}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-04', 'studyFirstSubmitDate': '2025-06-24', 'studyFirstSubmitQcDate': '2025-07-04', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory endpoint - Differences in pCR rates between predefined subgroups and factors influencing pCR in the study population.', 'timeFrame': 'through study completion, an average of 1 year'}], 'primaryOutcomes': [{'measure': 'Pathological Complete Response (pCR)', 'timeFrame': 'through study completion, up to 6 months'}], 'secondaryOutcomes': [{'measure': 'Event-Free Survival (EFS)', 'timeFrame': '5 years after surgery'}, {'measure': 'Invasive Disease-Free Survival (iDFS)', 'timeFrame': '5 years after surgery'}, {'measure': 'Safety-Number of adverse events and serious adverse events.', 'timeFrame': 'up to 1 year'}, {'measure': 'Tolerability-Dose adjustment rate and withdrawal rate of chemotherapy drugs', 'timeFrame': 'up to 1 year'}, {'measure': 'Residual Cancer Burden (RCB)', 'timeFrame': 'up to 6 months', 'description': 'Proportion of patients with residual cancer burden score of 0-1 after surgery'}, {'measure': 'EORTC QLQ-C30 score', 'timeFrame': 'up to 1 year', 'description': 'quality of life evaluated by EORTC QLQ-C30'}, {'measure': 'EORTC QLQ-BR23 score', 'timeFrame': 'up to 1 year', 'description': 'quality of life evaluated by EORTC QLQ-BR23'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HER2 positive', 'neoadjuvant therapy', 'Chemotherapy de-escalation'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the efficacy of nab-paclitaxel (on days 1 and 8 of a 21-day cycle) compared to the standard regimen of docetaxel plus carboplatin, both combined with trastuzumab and pertuzumab, as neoadjuvant therapies for HER2-positive breast cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nAge: 18-70 years old.\n\nClinical Tumor Stage: T2-T4d, or T1c with axillary lymph node positivity.\n\nHistologically confirmed HER2-positive invasive breast cancer:\n\nNote: HER2 positivity is defined as at least one assessment (either initial testing or central review) by the participating center's pathology department demonstrating tumor cells with immunohistochemistry (IHC) staining intensity of 3+ or confirmation by fluorescence in situ hybridization (FISH).\n\nClinically measurable disease: Lesion measurable by ultrasound or MRI (optional) within 1 month prior to randomization.\n\nAdequate organ and bone marrow function within 1 month prior to chemotherapy initiation (no contraindications to chemotherapy):\n\n1. Absolute neutrophil count (ANC) ≥ 2.0 × 10⁹/L\n2. Hemoglobin ≥ 100 g/L\n3. Platelet count ≥ 100 × 10⁹/L\n4. Total bilirubin \\< 1.5 × upper limit of normal (ULN)\n5. Serum creatinine \\< 1.5 × ULN\n6. Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) \\< 1.5 × ULN\n\nCardiac function: Left ventricular ejection fraction (LVEF) ≥ 55% assessed by echocardiography.\n\nWomen of childbearing potential: Negative serum pregnancy test within 14 days prior to randomization.\n\nPerformance status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nInformed consent: Provision of signed written informed consent.\n\nExclusion Criteria:\n\nStage IV (metastatic) breast cancer.\n\nBilateral breast cancer.\n\nPrior systemic therapy or radiotherapy for the current breast cancer diagnosis, including chemotherapy, endocrine therapy, or targeted therapy.\n\nHistory of a second primary malignancy, except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix.\n\nMajor surgery unrelated to breast cancer within 4 weeks prior to enrollment, or incomplete recovery from prior major surgery.\n\nSignificant cardiac disease or dysfunction, including but not limited to:\n\n1. History of congestive heart failure or systolic dysfunction (LVEF \\< 50%)\n2. High-risk uncontrolled arrhythmias (e.g., atrial tachycardia, resting heart rate \\> 100 bpm, clinically significant ventricular arrhythmia \\[e.g., ventricular tachycardia\\], or higher-grade atrioventricular block \\[i.e., Mobitz II second-degree or third-degree heart block\\])\n3. Angina pectoris requiring anti-anginal medication\n4. Clinically significant valvular heart disease\n5. Electrocardiogram (ECG) evidence of transmural myocardial infarction\n6. Poorly controlled hypertension (systolic blood pressure \\> 180 mmHg and/or diastolic blood pressure \\> 100 mmHg)\n\nPresence of any other severe, uncontrolled medical condition that, in the investigator's judgment, constitutes a contraindication to chemotherapy.\n\nKnown history of allergy to any component of the study drugs; patients with a history of immune deficiency diseases, including HIV positivity, or patients with other acquired or congenital immune deficiency diseases, or a history of organ transplantation."}, 'identificationModule': {'nctId': 'NCT07057427', 'briefTitle': 'Efficacy of Nab-PHP Versus TCbHP in Neoadjuvant Therapy for HER2-positive Early Breast Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Henan Cancer Hospital'}, 'officialTitle': 'Comparing the Efficacy of Nab-PHP and TCbHP in Neoadjuvant Therapy for HER2-positive Early Breast Cancer, A Multicenter, Randomized, Phase III Clinical Trial', 'orgStudyIdInfo': {'id': 'HELEN-006Lite'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nab-PHP group', 'description': 'Nab-paclitaxel(on days 1 and 8 of a 21-day cycle) + trastuzumab+ patuzumab (every 3 weeks)', 'interventionNames': ['Drug: Nab paclitaxel', 'Drug: Trastuzumab + Pertuzumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TCbHP', 'description': 'Docetaxel + carboplatin + trastuzumab + patuzumab (every 3 weeks)', 'interventionNames': ['Drug: Docetaxel and Carboplatin', 'Drug: Trastuzumab + Pertuzumab']}], 'interventions': [{'name': 'Nab paclitaxel', 'type': 'DRUG', 'description': 'Nab-paclitaxel (on days 1 and 8 of a 21-day cycle)', 'armGroupLabels': ['Nab-PHP group']}, {'name': 'Docetaxel and Carboplatin', 'type': 'DRUG', 'description': 'Docetaxel 75 mg/m2(day 1) + Carboplatin (AUC=6) (day 1)', 'armGroupLabels': ['TCbHP']}, {'name': 'Trastuzumab + Pertuzumab', 'type': 'DRUG', 'description': 'Trastuzumab (8mg/kg first dose, 6mg/kg sequential) and pertuzumab (840mg first dose, 420mg/kg sequential) were administered intravenously every 3 weeks, or fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (1200 mg pertuzumab plus 600 mg trastuzumab loading dose in 15 mL, followed by 600 mg pertuzumab plus 600 mg trastuzumab maintenance doses in 10 mL), both administered every 3 weeks.', 'armGroupLabels': ['Nab-PHP group', 'TCbHP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhenzhen Liu, PHD', 'role': 'CONTACT', 'email': 'zlyyliuzhenzhen0800@zzu.edu.cn', 'phone': '13603862755'}], 'facility': 'Henan cancer hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Zhenzhen Liu, PHD', 'role': 'CONTACT', 'email': 'zlyyliuzhenzhen0800@zzu.edu.cn', 'phone': '13603862755'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhenzhen Liu', 'investigatorAffiliation': 'Henan Cancer Hospital'}}}}