Ignite Creation Date:
2025-12-24 @ 12:53 PM
Ignite Modification Date:
2026-01-07 @ 9:27 AM
Study NCT ID:
NCT05346861
Status:
UNKNOWN
Last Update Posted:
2022-04-26
First Post:
2022-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pyrotinib Rechallenge in Her2-positive Metastatic Breast Cancer Pretreated With Pyrotinib and Trastuzumab
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': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'C000622954', 'term': 'pyrotinib'}], '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': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-20', 'studyFirstSubmitDate': '2022-04-20', 'studyFirstSubmitQcDate': '2022-04-20', 'lastUpdatePostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'approximately 8 months'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'approximately 8 months'}, {'measure': 'Adverse Events (AEs)', 'timeFrame': 'From the first drug administration to within 28 days for the last treatment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HER2-positive Breast Cancer', 'Metastatic Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '39024777', 'type': 'DERIVED', 'citation': 'Dai L, Gao T, Guo R, Chen Y, Wang J, Zhou S, Tang Y, Chen D, Huang S. Efficacy and safety of pyrotinib-based regimens in HER2 positive metastatic breast cancer: A retrospective real-world data study. Neoplasia. 2024 Oct;56:101029. doi: 10.1016/j.neo.2024.101029. Epub 2024 Jul 17.'}]}, 'descriptionModule': {'briefSummary': 'Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized, open-label, multi-center, parallel design study of the combination of pyrotinib, trastuzumab and chemotherapy versus trastuzumab and chemotherapy in HER2+ MBC patients, who have prior received trastuzumab and pyrotinib. Patients will be randomized in a 2:1 ratio to one of the following treatment arms. Arm A: pyrotinib + trastuzumab + chemotherapy, Arm B: trastuzumab + chemotherapy. Patients will receive either arm of therapy until disease progression, unacceptable toxicity, or withdrawal of consent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged ≥18 and ≤75 years;\n2. Pathologically confirmed HER2 positive patients with recurrence/ metastatic breast cancer: HER2 IHC 3+, or HER2 IHC 2+ and FISH detection gene amplification;\n3. History of trastuzumab-containing chemotherapy in neoadjuvant, adjuvant or recurrence/ metastatic setting;\n4. History of pyrotinib-containing chemotherapy in neoadjuvant or recurrence/ metastatic setting;\n5. Previously reveived ≤2 systemic treatment in recurrence/ metastasis setting; (anti-HER2 ADCs such as T-DM1 is included in chemotherapy regimens, endocrine therapy alone is not included);\n6. ECOG performance status of 0 to 1;\n7. According to RECIST 1.1, at least one extracranial measurable lesion exists；\n8. Signed informed consent.\n\nExclusion Criteria:\n\n1. Patients with leptomeningeal metastasis or unstable brain metastasis;\n2. History of neurological or psychiatric disorders;\n3. Second malignancies within 5 years, except for cured skin basal cell carcinoma, carcinoma in-situ of uterine cervix and squamous-cell carcinoma;\n4. Undergone major surgical procedures or significant trauma within 4 weeks prior to randomization, or expected to undergo major surgery.\n5. Factors influencing the usage of oral administration (e.g. unable to swallow, chronic diarrhea and intestinal obstruction, etc.);\n6. History of allergies to the drug components of this regimen;\n7. History of Immunodeficiency, acquired or congenital immunodeficiency (HIV positive), history of organ transplantation;\n8. Any other situations judged by investigator as not suitable for participating in this study.'}, 'identificationModule': {'nctId': 'NCT05346861', 'briefTitle': 'Pyrotinib Rechallenge in Her2-positive Metastatic Breast Cancer Pretreated With Pyrotinib and Trastuzumab', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Pyrotinib Rechallenge in Her2-positive Metastatic Breast Cancer Pretreated With Pyrotinib and Trastuzumab', 'orgStudyIdInfo': {'id': 'YBCSG-21-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Trastuzumab plus chemotherapy', 'interventionNames': ['Drug: Trastuzumab plus chemotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Pyrotinib in combination with Trastuzumab plus chemotherapy', 'interventionNames': ['Drug: Trastuzumab in combination with pyrotinib plus chemotherapy']}], 'interventions': [{'name': 'Trastuzumab plus chemotherapy', 'type': 'DRUG', 'description': 'Trastuzumab: 8 mg/kg loading dose followed by 6 mg/kg, Q3W Chemotherapy regimen is chosen from the following: Vinorelbine, Gemcitabine, taxanes or Eribulin monotherapy Experimental: Pyrotinib +Trastuzumab + chemotherapy', 'armGroupLabels': ['Trastuzumab plus chemotherapy']}, {'name': 'Trastuzumab in combination with pyrotinib plus chemotherapy', 'type': 'DRUG', 'description': 'Pyrotinib: 400 mg po QD, Q3W Chemotherapy regimen is chosen from the following: Vinorelbine, Gemcitabine, taxanes or Eribulin monotherapy', 'armGroupLabels': ['Pyrotinib in combination with Trastuzumab plus chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jian Zhang, MD,PhD', 'role': 'CONTACT', 'email': 'syner2000@163.com', 'phone': '+8664175590', 'phoneExt': '85000'}], 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jian Zhang,MD', 'investigatorAffiliation': 'Fudan University'}}}}