Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-01-01 @ 1:08 AM
Study NCT ID:
NCT06535893
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2024-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sustainable and Efficient Platform Trial of New Therapeutic Development for Early 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2040-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2024-07-30', 'studyFirstSubmitQcDate': '2024-07-30', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pathological complete response (pCR)', 'timeFrame': 'Baseline to surgery', 'description': 'pCR is defined as the absence of invasive cancer in the breast and sampled regional lymph nodes.'}, {'measure': 'ctDNA clearance rate', 'timeFrame': 'Before Neoadjuvant chemotherapy to surgery', 'description': 'ctDNA test was performed by Natera'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Randomized phase II trial targeting early-stage breast cancer (stage II-III) applicable to preoperative chemotherapy (NAC), comparing standard treatment with multiple experimental treatments.', 'detailedDescription': 'This randomized phase II trial targets early-stage breast cancer (stage II-III) with preoperative chemotherapy (NAC). It compares standard treatment with multiple experimental treatments using an adaptive design, allowing new treatments to be added during or after the trial. Patients are classified by subtype and randomized between standard and experimental treatments.\n\nThe trial is flexible, permitting single or combination new drug therapies and incorporating circulating tumor DNA (ctDNA) evaluation for precise efficacy and prognosis prediction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically or cytologically confirmed invasive breast carcinoma\n2. Stage II or III\n3. ECOG performance status of 0 or 1\n4. Age 18-80\n\nExclusion Criteria:\n\n1. Continuous systemic administration (oral or intravenous) of steroid drugs or other immunosuppressants.\n2. History or complication of interstitial lung disease or pulmonary fibrosis diagnosed by imaging or clinical findings.\n3. Infection requiring systemic treatment.\n4. Active double cancer (however, the following are not excluded: (1) Completely resected cancers: basal cell carcinoma, squamous cell carcinoma at clinical stage I, carcinoma in situ, mucosal carcinoma, superficial bladder carcinoma, (2) Gastrointestinal cancer that has been curatively resected by ESD or EMR, (3) Other cancers that have not recurred for more than 5 years).'}, 'identificationModule': {'nctId': 'NCT06535893', 'briefTitle': 'Sustainable and Efficient Platform Trial of New Therapeutic Development for Early Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Nagoya City University'}, 'officialTitle': 'Sustainable and Efficient Platform of New Therapeutic Development for Early Breast Cancer (S-FACT)', 'orgStudyIdInfo': {'id': 'JCOG2205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'JCOG2205-TN', 'description': 'KEYNOTE-522 regimen: Carboplatin + paclitaxel + pembrolizumab followed by doxorubicin + cyclophosphamide + pembrolizumab', 'interventionNames': ['Drug: TN']}, {'type': 'EXPERIMENTAL', 'label': 'JCOG2205-TN-1', 'description': 'Carboplatin + paclitaxel + pembrolizumab followed by niraparib + pembrolizumab', 'interventionNames': ['Drug: TN-1']}], 'interventions': [{'name': 'TN', 'type': 'DRUG', 'description': 'Carboplatin + paclitaxel + pembrolizumab followed by doxorubicin + cyclophosphamide + pembrolizumab', 'armGroupLabels': ['JCOG2205-TN']}, {'name': 'TN-1', 'type': 'DRUG', 'otherNames': ['KEYNOTE-522 regimen'], 'description': 'Carboplatin + paclitaxel + pembrolizumab followed by niraparib + pembrolizumab Niraparib Pembrolizumab AC', 'armGroupLabels': ['JCOG2205-TN-1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '467-8601', 'city': 'Nagoya', 'state': 'Aichi-ken', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kazuki Nozawa, MD', 'role': 'CONTACT', 'email': 'k.nozawa@med.nagoya-cu.ac.jp', 'phone': '052-853-8628'}, {'name': 'Kazuki Nozawa, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nagoya City University', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nagoya City University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Japan Clinical Oncology Group', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kazuki Nozawa', 'investigatorAffiliation': 'Nagoya City University'}}}}