Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2025-12-25 @ 1:41 PM
Study NCT ID:
NCT07283692
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neoadjuvant Serplulimab Plus Weekly Paclitaxel and Carboplatin in TNBC (Neo-SERPENT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}, {'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': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}], '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': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2031-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2025-12-04', 'studyFirstSubmitQcDate': '2025-12-04', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pCR', 'timeFrame': '1-2 weeks after surgery', 'description': 'pathological complete response'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'From the date of starting neoadjuvant therapy to the end of the treatment (up to approximately 1 year)', 'description': 'Adverse events during neoadjuvant therapy will be assessed according to the NCI CTCAE v5.0.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer', 'neoadjuvant', 'serplulimab'], 'conditions': ['Triple Negative Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is an prospective, open label, multicenter study to evaluate the efficacy and safety of neoadjuvant serplulimab plus weekly paclitaxel and carboplatin in patients with triple-negative breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female, Aged ≥18 and ≤70 years\n* Histologically confirmed triple negative breast cancer (ER\\<10%, PR\\<10%, and HER2 negative)\n* Subjects with at least one evaluable lesion\n* ECOG 0-1\n* Adequate organ function\n\nExclusion Criteria:\n\n* Metastatic disease (Stage IV)\n* Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test;Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period'}, 'identificationModule': {'nctId': 'NCT07283692', 'briefTitle': 'Neoadjuvant Serplulimab Plus Weekly Paclitaxel and Carboplatin in TNBC (Neo-SERPENT)', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'NEOadjuvant SERplulimab Plus Weekly PaclitaxEl and carboplatiN in Triple-negative Breast Cancer: a Prospective, Single-arm, Multicenter, Phase 2 Clinical Trial', 'orgStudyIdInfo': {'id': 'LY2025-277-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'neoadjuvant serplulimab', 'description': 'serplulimab in combination with weekly paclitaxel and carboplatin as neoadjuvant therapy', 'interventionNames': ['Drug: Serplulimab', 'Drug: Paclitaxel', 'Drug: Carboplatin']}], 'interventions': [{'name': 'Serplulimab', 'type': 'DRUG', 'description': '1.5mg/kg qw, start from C1D15', 'armGroupLabels': ['neoadjuvant serplulimab']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': '80mg/m\\^2 qw', 'armGroupLabels': ['neoadjuvant serplulimab']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'AUC=1.5, D1, 8, 15, every 28 days', 'armGroupLabels': ['neoadjuvant serplulimab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'country': 'China', 'facility': 'Renji Hospital, School of Medicine, Shanghai Jiaotong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Wenjin Yin, M.D.', 'role': 'CONTACT', 'email': 'yinwenjin@renji.com', 'phone': '86(21)68385569'}], 'overallOfficials': [{'name': 'Wenjin Yin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Renji Hospital,School of Medicine, Shanghai Jiaotong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Chief of Breast Surgery Department', 'investigatorFullName': 'Wenjin Yin', 'investigatorAffiliation': 'RenJi Hospital'}}}}