Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-29 @ 10:39 PM
Study NCT ID:
NCT06802757
Status:
RECRUITING
Last Update Posted:
2025-06-17
First Post:
2025-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Posaconazole Plus Pembrolizumab and Chemotherapy vs Pembrolizumab and Chemotherapy in Neoadjuvant Therapy for Triple Negative Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C101425', 'term': 'posaconazole'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'C582435', 'term': 'pembrolizumab'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-13', 'studyFirstSubmitDate': '2025-01-16', 'studyFirstSubmitQcDate': '2025-01-25', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological Complete Response', 'timeFrame': '24 weeks', 'description': 'Expected 10% increase in pCR rate'}], 'secondaryOutcomes': [{'measure': 'Breast pathological complete response', 'timeFrame': '24 weeks'}, {'measure': 'Objective response rate', 'timeFrame': '24 weeks'}, {'measure': '3-year event-free survival rate', 'timeFrame': 'After a median follow-up of 3 years'}, {'measure': 'Survival rate', 'timeFrame': 'After a median follow-up of 3 years'}, {'measure': 'Security', 'timeFrame': '24 weeks', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Triple-Negative Breast Cancer', 'Pathological Complete Response', 'Neoadjuvant Therapy', 'Posaconazole'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Triple-negative breast cancer (TNBC) is as sociated with shorter overall survival than other breast cancer subtypes, despite the use of curative-intent anthracycline- and taxane-based systemic chemotherapy. Neoadjuvant therapy is now also recognized as the standard treatment for patients with high-risk TNBC. The Keynote-522 study demonstrated that the application of pembrolizumab has raised the pathological Complete Response (pCR) rate in TNBC to over 60%, but nearly 40% of patients still do not achieve pCR. How to further improve the pCR rate in TNBC patients has become a hot topic of current research.\n\nPosaconazole is an antibiotic used to prevent invasive Aspergillus and Candida infections and to treat oropharyngeal candidiasis. Our preclinical studies have found that posaconazole can inhibit immune cell-mediated steroidogenesis to restrict TNBC tumor progression. The investigators design and begin a a prospective randomized controlled clinical study to explore the effectiveness of posaconazole in the neoadjuvant treatment of TNBC.', 'detailedDescription': 'OBJECTIVES: On the basis of chemotherapy combined with immunotherapy, posaconazole was used to further improve the pathological complete response (pCR) rate of high-risk triple-negative breast cancer (TNBC), and to explore biomarkers.\n\nOUTLINE: From february 1st, 2025 to june 30th, 2026 the investigators will recruit 40 patients with first-time diagnosed early-stage TNBC. Enrolled patients were randomly divided into experimental group and control group on a 1:1 basis. Both groups received standard neoadjuvant chemotherapy combined with immunotherapy. The experimental group was treated with posaconazole (day 1: 300 mg po bid, from Day 2, start maintenance dose at 300 mg po qd, q21d). Standard surgical treatment was performed after 8 cycles and the surgical specimens were pathologically tested to compare the differences in pCR rates between the two groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female, aged ≥ 18 and ≤ 70 years old;\n2. first-confirmed TNBC;\n3. cT1cN1-3M0 or cT2-4N0-3M0;\n4. ECOG score 0-1 points.\n\nExclusion Criteria:\n\n1. Stage I or IV;\n2. History of previous breast cancer;\n3. Patients with a history of other tumors who have received systemic therapy or local radiotherapy;\n4. No immune system disease or connective tissue disease;\n5. No history of hormone therapy;\n6. Pregnant/lactating.'}, 'identificationModule': {'nctId': 'NCT06802757', 'acronym': 'PRISM-TNBC', 'briefTitle': 'Posaconazole Plus Pembrolizumab and Chemotherapy vs Pembrolizumab and Chemotherapy in Neoadjuvant Therapy for Triple Negative Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Shandong Cancer Hospital and Institute'}, 'officialTitle': 'A Phase II, Randomised, Open-label, Multicentre Study of Posaconazole Plus Pembrolizumab and Chemotherapy Versus Pembrolizumab and Chemotherapy as Neoadjuvant Therapy for Triple Negative Breast Cancer', 'orgStudyIdInfo': {'id': 'POS-PEM-Ⅱ-NEO-TNBC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Chemotherapy + PD-1 inhibitor', 'description': 'Nab-paclitaxel + carboplatin 4 cycles, sequential anthracycline + cyclophosphamide 4 cycles in combination with pembrolizumab', 'interventionNames': ['Drug: Nab-paclitaxel', 'Drug: Carboplatin', 'Drug: Anthracycline', 'Drug: Cyclophosphamide', 'Drug: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Chemotherapy + PD-1 inhibitor+Posaconazole', 'description': 'Nab-paclitaxel + carboplatin 4 cycles, sequential anthracycline + cyclophosphamide 4 cycles in combination with pembrolizumab and posaconazole', 'interventionNames': ['Drug: Posaconazole', 'Drug: Nab-paclitaxel', 'Drug: Carboplatin', 'Drug: Anthracycline', 'Drug: Cyclophosphamide', 'Drug: Pembrolizumab']}], 'interventions': [{'name': 'Posaconazole', 'type': 'DRUG', 'description': 'Posaconazole 120mg/m2 po bid d1-14 q21d', 'armGroupLabels': ['Chemotherapy + PD-1 inhibitor+Posaconazole']}, {'name': 'Nab-paclitaxel', 'type': 'DRUG', 'description': 'Nab-paclitaxel 260mg/m2 d1 q21d', 'armGroupLabels': ['Chemotherapy + PD-1 inhibitor', 'Chemotherapy + PD-1 inhibitor+Posaconazole']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Carboplatin AUC=6 d1 q21d', 'armGroupLabels': ['Chemotherapy + PD-1 inhibitor', 'Chemotherapy + PD-1 inhibitor+Posaconazole']}, {'name': 'Anthracycline', 'type': 'DRUG', 'description': 'Epirubicin 90-100mg/m2 d1 q21d or Doxorubicin 50-60mg/m2 d1 q21d', 'armGroupLabels': ['Chemotherapy + PD-1 inhibitor', 'Chemotherapy + PD-1 inhibitor+Posaconazole']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Cyclophosphamide 1000mg/m2 d1 q21d', 'armGroupLabels': ['Chemotherapy + PD-1 inhibitor', 'Chemotherapy + PD-1 inhibitor+Posaconazole']}, {'name': 'Pembrolizumab', 'type': 'DRUG', 'description': 'Pembrolizumab 200mg d1 q21d', 'armGroupLabels': ['Chemotherapy + PD-1 inhibitor', 'Chemotherapy + PD-1 inhibitor+Posaconazole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250117', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Pengfei Qiu', 'role': 'CONTACT', 'email': 'qiu.pf@outlook.com', 'phone': '+86053167626215'}], 'facility': 'Breast Cancer Center Shandong Cancer Hospital and Institute Shandong First Medical University and Shandong Academy of Medical Sciences', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Pengfei Qiu, MD', 'role': 'CONTACT', 'email': 'qiu.pf@outlook.com', 'phone': '+86053167626215'}, {'name': 'Zhiqiang Shi, MD', 'role': 'CONTACT', 'email': 'shizhiqiang1024@163.com', 'phone': '+86053167626215'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong Cancer Hospital and Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yongsheng Wang', 'investigatorAffiliation': 'Shandong Cancer Hospital and Institute'}}}}