Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:03 AM
Study NCT ID:
NCT07466303
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serplulimab Combined With Trastuzumab Rezetecan as Neoadjuvant Therapy for Triple-Negative Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D064726', 'term': 'Triple Negative 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2031-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological Complete Response (pCR) Rate', 'timeFrame': 'At the time of definitive surgery (after 6 cycles of neoadjuvant therapy; each cycle is 21 days).', 'description': 'Proportion of participants achieving a pathological complete response, defined as the absence of residual invasive cancer in the breast and sampled ipsilateral lymph nodes (ypT0/Tis, ypN0) upon pathological review of the surgical resection specimen following completion of neoadjuvant therapy.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'From baseline until the end of neoadjuvant therapy (up to 6 cycles), with tumor assessments performed at the end of Cycles 2, 4, and 6（each cycle is 21days).', 'description': 'Proportion of participants achieving a best overall response of complete response or partial response, as assessed by the investigator per Response Evaluation Criteria in Solid Tumors version 1.1 during the neoadjuvant treatment phase.'}, {'measure': 'Invasive Disease-Free Survival (iDFS)', 'timeFrame': 'From surgery until first documented iDFS event or death, assessed up to 5 years (60 months).', 'description': 'Time from the date of definitive surgery to the date of the first occurrence of invasive ipsilateral breast tumor recurrence, invasive loco-regional recurrence, distant recurrence, or death from any cause.'}, {'measure': 'Event-Free Survival (EFS)', 'timeFrame': 'From enrollment until first documented EFS event or death, assessed up to 5 years (60 months).', 'description': 'Time from the date of enrollment to the date of the first occurrence of any of the following: disease progression that precludes planned surgery, invasive local/regional or distant recurrence following surgery, or death from any cause.'}, {'measure': 'Breast-Conserving Surgery Rate', 'timeFrame': 'During surgery', 'description': 'Proportion of participants who undergo successful breast-conserving surgery as the definitive surgical procedure following neoadjuvant therapy.'}, {'measure': 'Incidence and Severity of Adverse Events', 'timeFrame': 'From first study treatment administration until 30 days after the last dose (approximately 25 weeks).', 'description': 'Frequency, severity (graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0), and investigator-assessed relationship to study treatment of all adverse events and serious adverse events.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neoadjuvant Therapy', 'Pathological Complete Response', 'Serplulimab', 'PD-1 Inhibitor', 'Antibody-Drug Conjugate', 'Trastuzumab Deruxtecan', 'Phase II Clinical Trial', 'Triple-Negative Breast Cancer', 'HER2-Low Breast Cancer'], 'conditions': ['Breast Cancer', 'Serplulimab Combined With SHR-A1811 as Neoadjuvant Therapy for Triple-Negative Breast Cancer']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of Serplulimab in combination with Trastuzumab Restuzumab for the neoadjuvant treatment of triple-negative breast cancer, aiming to provide evidence for optimizing the strategy of combining immunotherapy with ADC drugs in the neoadjuvant setting.', 'detailedDescription': "This is a prospective, single-arm, open-label, Phase II clinical trial investigating the efficacy and safety of a non-chemotherapy regimen comprising Serplulimab (an anti-PD-1 monoclonal antibody) and Trastuzumab Restuzumab (SHR-A1811, an antibody-drug conjugate) as neoadjuvant therapy for early-stage triple-negative breast cancer.\n\nPrimary Objective:To assess the pathological complete response rate, defined as the absence of invasive carcinoma in both the breast and sampled regional lymph nodes (ypT0/Tis ypN0), following neoadjuvant treatment with serplulimab plus SHR-A1811.\n\nSecondary Objectives:\n\nTo evaluate invasive disease-free survival, event-free survival, and the objective response rate according to RECIST 1.1 criteria.\n\nTo determine the rate of breast-conserving surgery. To characterize the safety and tolerability profile of the combination regimen, including the incidence and severity of adverse events.\n\nStudy Design:\n\nThis study employs a Simon's two-stage, single-arm design. Approximately 84 treatment-naïve female patients with early-stage TNBC (clinical stage T1cN1-2 or T2-4N0-2) will be enrolled. Participants will receive six cycles of serplulimab and SHR-A1811 prior to definitive surgery. The primary endpoint will be centrally assessed on the surgical pathology specimen.\n\nInterventions:\n\nSerplulimab: Administered intravenously at a protocol-specified dose every three weeks for six cycles.\n\nSHR-A1811: Administered intravenously at a protocol-specified dose every three weeks for six cycles.\n\nStatistical Methods:\n\nThe study is designed to test the hypothesis that the combination regimen will increase the pCR rate from a historical benchmark of 30% to 40%. With a one-sided alpha level of 0.05 and 80% statistical power, a minimum of 75 evaluable patients is required. Allowing for an estimated 10% dropout rate, a total of 84 patients will be enrolled. The primary efficacy analysis of the pCR rate will be conducted on the full analysis set using an exact binomial test. The 95% confidence interval for the pCR rate will be calculated via the Clopper-Pearson exact method. Time-to-event endpoints will be analyzed using the Kaplan-Meier method."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients aged 18 to 70 years, inclusive.\n* Histologically confirmed, treatment-naïve, early-stage triple-negative breast cancer (TNBC), defined as estrogen receptor (ER) and progesterone receptor (PR) expression \\<1% by immunohistochemistry (IHC), and human epidermal growth factor receptor 2 (HER2)-negative (IHC 0/1+ or IHC 2+ with negative in situ hybridization confirmation) per current American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines.\n* Clinical stage T1cN1-2 or T2-4N0-2 according to the American Joint Committee on Cancer (AJCC) staging system, 8th edition.\n* At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate hematologic, hepatic, renal, and cardiac function within 14 days prior to enrollment:\n\n * Hematologic: Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L; platelet count ≥100 × 10⁹/L; hemoglobin ≥90 g/L (without transfusion or growth factor support within 14 days).\n * Hepatic: Total bilirubin ≤1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN.\n * Renal: Serum creatinine and blood urea nitrogen (BUN) ≤1.5 × ULN.\n * Cardiac: Left ventricular ejection fraction (LVEF) ≥50% measured by echocardiogram; corrected QT interval (QTc) \\<470 ms on 12-lead electrocardiogram (ECG).\n* Willingness to provide archival or fresh tumor tissue sample for programmed death-ligand 1 (PD-L1) biomarker analysis using the 22C3 pharmDx assay.\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Evidence of metastatic (Stage IV) disease or bilateral breast cancer at diagnosis.\n* Prior systemic anticancer therapy (including chemotherapy, endocrine therapy, immunotherapy, or biological therapy) for any malignancy within 4 weeks before the first dose of study treatment.\n* Diagnosis of any other malignancy within the past 5 years, except for adequately treated non-melanoma skin cancer, basal cell carcinoma, or carcinoma in situ of the cervix.\n* Known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV-DNA ≥500 IU/mL), or hepatitis C virus (detectable HCV-RNA).\n* Active autoimmune disease requiring systemic immunosuppressive therapy within the past 2 years.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring systemic antibiotic therapy within 2 weeks, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements.\n* History of allogeneic hematopoietic stem cell or solid organ transplantation.\n* Pregnant or lactating women, or women of childbearing potential who are unwilling to use a highly effective method of contraception during the treatment period and for at least 7 months after the last dose.\n* Known hypersensitivity to any component of serplulimab or SHR-A1811.\n* Any condition that, in the opinion of the investigator, would compromise patient safety or interfere with the completion of the study procedures.'}, 'identificationModule': {'nctId': 'NCT07466303', 'briefTitle': 'Serplulimab Combined With Trastuzumab Rezetecan as Neoadjuvant Therapy for Triple-Negative Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Serplulimab Combined With Trastuzumab Rezetecan as Neoadjuvant Therapy for Triple-Negative Breast Cancer: A Phase II Single-Arm Clinical Study', 'orgStudyIdInfo': {'id': 'KY20252486-F-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neoadjuvant Serplulimab + SHR-A1811', 'description': 'All enrolled participants will receive the investigational combination therapy as neoadjuvant treatment. This regimen consists of Serplulimab (an anti-PD-1 monoclonal antibody) and SHR-A1811 (Trastuzumab Restuzumab , an antibody-drug conjugate). Both agents are administered intravenously every 3 weeks (Q3W) for 6 cycles prior to definitive surgery. The primary objective is to evaluate the efficacy and safety of this chemotherapy-free combination in patients with early-stage triple-negative breast cancer (TNBC).', 'interventionNames': ['Drug: Serplulimab', 'Drug: SHR-A1811']}], 'interventions': [{'name': 'Serplulimab', 'type': 'DRUG', 'description': 'Administered intravenously at a protocol-specified dose, once every 3 weeks (Q3W), for a total of 6 cycles in the neoadjuvant setting.', 'armGroupLabels': ['Neoadjuvant Serplulimab + SHR-A1811']}, {'name': 'SHR-A1811', 'type': 'DRUG', 'description': 'Administered intravenously at a protocol-specified dose, once every 3 weeks (Q3W), for a total of 6 cycles in the neoadjuvant setting.', 'armGroupLabels': ['Neoadjuvant Serplulimab + SHR-A1811']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'country': 'China', 'contacts': [{'name': 'Ju Liang J L Zhang, MD', 'role': 'CONTACT', 'email': 'vascularzhang@163.com', 'phone': '029-84775271'}], 'facility': 'the First Affiliated Hospital of the Air Force Medical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Ju Liang Zhang, Prof', 'role': 'CONTACT', 'email': 'vascularzhang@163.com', 'phone': '029-84775271'}, {'name': 'Mei Ling Huang, MD', 'role': 'CONTACT', 'email': 'huangmeiling@126.com', 'phone': '029-84775271'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}