Ignite Creation Date:
2025-12-24 @ 12:24 PM
Ignite Modification Date:
2025-12-27 @ 9:39 PM
Study NCT ID:
NCT05891561
Status:
RECRUITING
Last Update Posted:
2024-11-27
First Post:
2023-05-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short-course Trastuzumab, Pertuzumab with Taxanes in the Adjuvant Treatment of Early HER2-positive 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': 'C485206', 'term': 'pertuzumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-24', 'studyFirstSubmitDate': '2023-05-21', 'studyFirstSubmitQcDate': '2023-06-04', 'lastUpdatePostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease free survival [DFS]', 'timeFrame': '3 year', 'description': 'Time from surgery to first proven loco-regional recurrence, distant recurrence, second non-breast malignancy, or death from any cause'}], 'secondaryOutcomes': [{'measure': 'Overall survival [OS]', 'timeFrame': '3 year', 'description': 'Time from surgery to death from any cause'}, {'measure': 'Distant disease-free survival [DDFS]', 'timeFrame': '3 year', 'description': 'Time from surgery to first proven distant recurrence, second non-breast malignancy, or death from any cause'}, {'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': '3 year', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer', 'pertuzumab', 'her2', 'adjuvant'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The investigators plan to carry out a phase II, open-label, single-arm clinical study of short-course trastuzumab, pertuzumab combined with taxanes in the adjuvant treatment of early HER2-positive breast cancer, to explore whether 4 courses of dual HER2 blockade combined with taxanes can lead to a similar prognosis with current standard treatment, which is one-year trastuzumab monotherapy combined with chemotherapy, while reducing the adverse reactions of treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically diagnosed unilateral primary invasive breast cancer patient with pT1, pN0, and M0 disease\n* HER2-positive, ie. immunohistochemistry \\[IHC\\] 3+ or IHC 2+ and fluorescence in situ hybridisation \\[FISH\\]-positive according to ASCO/CAP 2018 guidelines\n* complete clinical pathological information\n* Eastern Cooperative oncology Group \\[ECOG\\] 0-1\n* Currently not pregnant or breast-feeding\n* Fine organ function\n* Have good compliance with planned treatment, understand the study process and sign a written informed consent\n\nExclusion Criteria:\n\n* Bilateral or metastatic breast cancer\n* Receiving neoadjuvant treatment\n* Other malignancies within 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer\n* Severe systemic infections or other serious illnesses\n* HIV infection, active hepatitis B or C infection\n* Known allergy to or intolerance to a therapeutic drug or its excipients\n* Prior history of chemotherapy, endocrine therapy, biotherapy, or radiation therapy for any reason\n* Enrollment of another investigational study within 4 weeks prior to initial administration of the investigational treatment\n* Receiving live vaccine within 30 days prior to initial administration of the investigational treatment\n* History of mental illness or drug abuse that may affect compliance with the trial requirements\n* The researchers determine that the patients were not suitable for the study'}, 'identificationModule': {'nctId': 'NCT05891561', 'briefTitle': 'Short-course Trastuzumab, Pertuzumab with Taxanes in the Adjuvant Treatment of Early HER2-positive Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Short-course Trastuzumab, Pertuzumab Combined with Taxanes in the Adjuvant Treatment of Early Human Epidermal Growth Factor Receptor 2-positive Breast Cancer: an Open-label, Single-arm Study', 'orgStudyIdInfo': {'id': 'RJBC-THP4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pertuzumab', 'description': '4 cycles of taxane, Pertuzumab, Trastuzumab', 'interventionNames': ['Drug: Pertuzumab']}], 'interventions': [{'name': 'Pertuzumab', 'type': 'DRUG', 'description': '4 cycles of taxane, pertuzumab, trastuzumab', 'armGroupLabels': ['Pertuzumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaosong Chen', 'role': 'CONTACT', 'phone': '+8621-64370045*602102'}, {'name': 'Yiwei Tong', 'role': 'CONTACT', 'phone': '+8621-64370045*602107'}], 'facility': 'Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xiaosong Chen', 'role': 'CONTACT', 'email': 'chenxiaosong0156@hotmail.com', 'phone': '+8621-64370045*602102'}, {'name': 'Yiwei Tong', 'role': 'CONTACT', 'email': 'ash_yiwei@sjtu.edu.cn', 'phone': '+8621-64370045*602107'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kunwei Shen', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}