Ignite Creation Date:
2025-12-24 @ 11:45 AM
Ignite Modification Date:
2025-12-30 @ 10:20 AM
Study NCT ID:
NCT06394661
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-23
First Post:
2024-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serplulimab Plus Chemotherapy for Early-stage HR+/HER2- 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 109}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-20', 'studyFirstSubmitDate': '2024-04-28', 'studyFirstSubmitQcDate': '2024-04-28', 'lastUpdatePostDateStruct': {'date': '2025-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'PDL1 expression', 'timeFrame': 'up to 24 weeks', 'description': 'Evaluate the impact of PDL1 expression on treatment efficacy'}, {'measure': 'next-generation sequencing (NGS)', 'timeFrame': 'up to 24 weeks', 'description': 'NGS analysis to identify genetic alterations that predict response to anti-PD1 treatment'}, {'measure': 'blood based biomarker', 'timeFrame': 'up to 24 weeks', 'description': 'To evaluate blood based biomarkers include immune cell subsets and cytokines.'}, {'measure': '9-item depression module of the Patient Health Questionnaire-9', 'timeFrame': 'up to 24 weeks', 'description': 'PHQ-9 questionnaire to evaluate level of depression of participants.'}], 'primaryOutcomes': [{'measure': 'pathological complete response', 'timeFrame': 'up to 24 weeks', 'description': 'After neoadjuvant chemotherapy and surgery, the resected specimen (breast + axilla) was free of any invasive cancer (ie, ypT0/is, ypN0)'}], 'secondaryOutcomes': [{'measure': 'Event-Free Survival (EFS)', 'timeFrame': '5-10 years', 'description': 'EFS was defined as the time from randomization to any of the following events: disease progression during neoadjuvant therapy, local or distant recurrence, second primary malignancy (breast or other cancer), or death from any cause.'}, {'measure': 'DFS', 'timeFrame': '5-10 years', 'description': 'Disease-free Survival,From the date of surgery to the first local, regional, contralateral or distant recurrence, and death from any cause'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'up to 24 weeks', 'description': 'ORR is defined as proportion of patients demonstrating either a partial response (PR) or a complete response (CR)'}, {'measure': 'adverse events', 'timeFrame': 'After each cycle of chemotherapy (21 days as 1 cycle)]', 'description': 'Evaluate the nature, incidence and severity of chemotherapy adverse events according to CTCAE 5.0'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HR+ breast cancer', 'neoadjuvant', 'serplulimab'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if serplulimab is effective in early HR+/HER2- breast cancer. It will also learn about the safety of serplulimab. The main questions it aims to answer are:\n\nDoes serplulimab combined with neoadjuvant chemotherapy improve the pCR rate of early HR+/HER2- breast cancer? What medical problems do participants have when receiving serplulimab? Researchers will compare the effect of serplulimab combined with chemotherapy to the effect of chemotherapy reported in literature.\n\nParticipants will: Receive serplulimab plus chemotherapy every 3 weeks for 6 cycles; All patients will receive surgery, and the primary end point is a pathological complete response at the time of definitive surgery; After definitive surgery, the participants will receive adjuvant serplulimab every 3 weeks for up to 6 months from the beginning of the treatment.', 'detailedDescription': 'In recent years, significant progress has been made in the immunotherapy of breast cancer, and PD1/PDL1 inhibitors have achieved good results in the treatment of triple-negative breast cancer. There have also been many attempts to apply them in HR+/HER2- breast cancer. In the I-SPY2 study, Pembrolizumab combined with chemotherapy increased the pCR rate of HR+/HER2- breast cancer from 13% in the chemotherapy alone group to 30%. In the KEYNOTE756 study, Pembrolizumab in combination with chemotherapy increased the pCR rate by 8.5% (24.3% vs. 15.6%) compared to the chemotherapy-only arm in HR+/HER2- breast cancer. pCR rates in the Nivolumab arm of the CheckMate 7FL study were 24.5% compared with 13.8% in the control arm. While further long-term follow-up data are still needed to confirm patient benefit, it still provides a new treatment option for HR+/HER2- breast cancer patients.\n\nThe neoadjuvant treatment options commonly used for HR+/HER2- breast cancer are mainly anthracycline sequential or combined with paclitaxel chemotherapy regimens. Several clinical studies have confirmed that albumin paclitaxel is more effective than solvent-based paclitaxel, and therefore, albumin paclitaxel in combination with epirubicin has also become a commonly used chemotherapy regimen in clinical practice.\n\nThe aim of this study was to explore the efficacy and safety of the Serplulimab combined with nab-paclitaxel and epirubicin in the neoadjuvant treatment of HR+/HER2- breast cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nPatients must meet all of the following criteria to be eligible:\n\nAge: ≥18 years old.\n\nClinical-pathological confirmation:\n\ncT2-cT4 breast cancer, or cT1c with axillary lymph node metastasis.\n\nHistopathologically confirmed HR+/HER2- invasive breast cancer:\n\nER and/or PR positive (IHC nuclear staining ≥1%).\n\nHER2-negative (IHC 0 or 1+ without FISH testing, or IHC 2+ with FISH-negative amplification).\n\nKi67 ≥20%.\n\nClinically measurable lesions:\n\nMeasurable lesions confirmed by ultrasound, mammography, or MRI (optional) within 1 month prior to randomization.\n\nAdequate organ and bone marrow function (within 1 month prior to chemotherapy):\n\nAbsolute neutrophil count (ANC) ≥2.0 × 10\\^9/L.\n\nHemoglobin ≥90 g/L.\n\nPlatelet count ≥100 × 10\\^9/L.\n\nTotal bilirubin \\<1.5 × ULN (upper limit of normal).\n\nCreatinine \\<1.5 × ULN.\n\nAST/ALT \\<1.5 × ULN.\n\nCardiac function: Left ventricular ejection fraction (LVEF) ≥55% by echocardiography.\n\nReproductive status: Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization.\n\nECOG performance status: ≤1.\n\nInformed consent: Signed written informed consent.\n\nExclusion Criteria\n\nPatients meeting any of the following criteria will be excluded:\n\nEvidence of metastatic breast cancer:\n\nPrior systemic therapy: Chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for the current breast cancer.\n\nSecond primary malignancy, except: Adequately treated non-melanoma skin cancer.\n\nPrior immunotherapy: Treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or other immune checkpoint inhibitors.\n\nImmune-related conditions:\n\nDiagnosed immunodeficiency or active autoimmune disease.\n\nSevere cardiopulmonary disease: Uncontrolled or clinically significant.\n\nActive hepatitis B or C.\n\nPregnancy or lactation: Pregnant or breastfeeding women.\n\nOther contraindications: Severe uncontrolled comorbidities deemed by investigators to contraindicate chemotherapy or PD-1 inhibitor therapy.'}, 'identificationModule': {'nctId': 'NCT06394661', 'briefTitle': 'Serplulimab Plus Chemotherapy for Early-stage HR+/HER2- Breast Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Henan Cancer Hospital'}, 'officialTitle': 'Serplulimab Combined With NabPE for Early-stage Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Breast Cancer- A Single-arm, Multicenter, Phase 2 Clinical Study', 'orgStudyIdInfo': {'id': 'HELEN-018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Serplulimab group', 'description': 'NabPE+Serplulimab group（Epirubicin 75mg/m2 ivgtt on Day 1+Albumin Paclitaxel 260mg/m2 ivgtt on Day 1+Serplulimab 4.5mg/Kg ivgtt on Day 3）every 3 weeks for 6 cycles. Then paticipants will receive surgery and Serplulimab will be given as monotherapy every 3 weeks up to 6 months from the beginning of the treatment.', 'interventionNames': ['Drug: Serplulimab+NabPE']}], 'interventions': [{'name': 'Serplulimab+NabPE', 'type': 'DRUG', 'description': 'Serplulimab plus neoadjuvant nab-PE: Epirubicin 75mg/m2 ivgtt on Day 1+Albumin Paclitaxel 260mg/m2 ivgtt on Day 1+Serplulimab 4.5mg/Kg ivgtt on Day 3）', 'armGroupLabels': ['Serplulimab group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450008', 'city': 'Henan', 'state': 'Henan', 'country': 'China', 'facility': 'Henan cacer hospital', 'geoPoint': {'lat': 33.41499, 'lon': 112.42212}}], 'overallOfficials': [{'name': 'Zhenzhen Liu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henan Cancer Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhenzhen Liu', 'investigatorAffiliation': 'Henan Cancer Hospital'}}}}