Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-01-02 @ 7:19 AM
Study NCT ID:
NCT07111832
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial of SHR-A1811 in the Treatment of Triple-negative Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}], 'ancestors': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'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': 'D007267', 'term': 'Injections'}, {'id': 'C000656314', 'term': 'toripalimab'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2025-08-01', 'studyFirstSubmitQcDate': '2025-08-01', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival (PFS)', 'timeFrame': 'An average of 3 year.'}], 'secondaryOutcomes': [{'measure': 'Overall response (OS) rate evaluated by investigators', 'timeFrame': 'An average of 3 year.'}, {'measure': 'Clinical benefit rate (CBR) evaluated by investigators', 'timeFrame': 'An average of 3 year.'}, {'measure': 'Duration of response (DoR) evaluated by investigators', 'timeFrame': 'An average of 3 year.'}, {'measure': 'Progression-free survival on next-line therapy (PFS2) evaluated by investigators', 'timeFrame': 'An average of 3 year.'}, {'measure': 'Adverse events (AEs)', 'timeFrame': 'An average of 3 year.'}, {'measure': 'Serious adverse events (SAEs)', 'timeFrame': 'An average of 3 year.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the progression-free survival (PFS) of SHR-A1811 combined with SHR-1316 in the first-line treatment of PD-L1-positive locally recurrent unresectable or metastatic triple-negative breast cancer with Toripalimab combined with Nab-paclitaxel, as assessed by blinded independent central review (BICR).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-75 years old (including both ends), female.\n2. Pathologically confirmed locally recurrent unresectable or metastatic triple-negative breast cancer.\n3. Expected survival ≥ 12 weeks.\n4. Have adequate renal and hepatic function.\n5. Patients voluntarily joined the study and signed the informed consent.\n\nExclusion Criteria:\n\n1. Patients with active central nervous system (CNS) metastases who have not undergone surgery or radiotherapy.\n2. Have other malignancies within the past 5 years.\n3. Presence with uncontrollable third space effusion.\n4. Have undergone other anti-tumor treatment within 4 weeks before the first dose.\n5. A history of immunodeficiency.\n6. Clinically significant cardiovascular diseases.\n7. Known or suspected interstitial lung disease.\n8. Known hereditary or acquired bleeding tendency.\n9. Toxicities from prior anti-tumor therapy that have not recovered to ≤ Grade 1.\n10. Known hypersensitivity to any of the study drugs or their excipients, or a history of allergy to humanized monoclonal antibody products.\n11. Presence of other severe physical or mental disorders or clinically significant laboratory abnormalities.'}, 'identificationModule': {'nctId': 'NCT07111832', 'briefTitle': 'A Clinical Trial of SHR-A1811 in the Treatment of Triple-negative Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Suzhou Suncadia Biopharmaceuticals Co., Ltd.'}, 'officialTitle': 'A Phase III, Multicenter, Randomized, Open-label, Active-controlled Study of SHR-A1811 Plus SHR-1316 Versus Toripalimab Plus Nab-paclitaxel in PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer', 'orgStudyIdInfo': {'id': 'SHR-A1811-313'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-A1811 and SHR-1316 Group', 'interventionNames': ['Drug: SHR-A1811 for Injection', 'Drug: SHR-1316 Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Toripalimab and Nab-paclitaxel Group', 'interventionNames': ['Drug: Toripalimab Injection', 'Drug: Paclitaxel for Injection']}], 'interventions': [{'name': 'SHR-A1811 for Injection', 'type': 'DRUG', 'description': 'SHR-A1811 for injection.', 'armGroupLabels': ['SHR-A1811 and SHR-1316 Group']}, {'name': 'SHR-1316 Injection', 'type': 'DRUG', 'description': 'SHR-1316 injection.', 'armGroupLabels': ['SHR-A1811 and SHR-1316 Group']}, {'name': 'Toripalimab Injection', 'type': 'DRUG', 'description': 'Toripalimab injection.', 'armGroupLabels': ['Toripalimab and Nab-paclitaxel Group']}, {'name': 'Paclitaxel for Injection', 'type': 'DRUG', 'description': 'Paclitaxel for injection.', 'armGroupLabels': ['Toripalimab and Nab-paclitaxel Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huiping Li', 'role': 'CONTACT', 'email': 'huipingli2012@hotmail.com', 'phone': '+86-010-88196380'}, {'name': 'Huiping Li', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Peking University Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhimin Shao', 'role': 'CONTACT', 'email': 'szmgcp2-16@163.com', 'phone': '+86-021-64175590'}, {'name': 'Zhimin Shao', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cancer Hospital，Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Tingting Lei', 'role': 'CONTACT', 'email': 'tingting.lei.tl6@hengrui.com', 'phone': '+86-0518-82342973'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou Suncadia Biopharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}