Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:43 AM
Study NCT ID:
NCT07394218
Status:
RECRUITING
Last Update Posted:
2026-02-06
First Post:
2025-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ctDNA-guided Treatment Decision-making
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 122}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-01', 'studyFirstSubmitDate': '2025-12-18', 'studyFirstSubmitQcDate': '2026-02-01', 'lastUpdatePostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS) in TNBC (Group A vs Group B)', 'timeFrame': 'From randomization until progression or death (up to 36 months)', 'description': 'Time from randomization to disease progression or death, assessed by RECIST v1.1.'}], 'secondaryOutcomes': [{'measure': 'ORR (RECIST v1.1)，DoR，CBR，OS，Safety (CTCAE v5.0)', 'timeFrame': 'From treatment initiation until end of follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Breast Cancer ( HER2 Negative)', 'ctDNA']}, 'descriptionModule': {'briefSummary': 'This is an exploratory, ctDNA-guided, multi-stage clinical study designed to evaluate the clinical value of treatment decision-making based on circulating tumor DNA (ctDNA) variant allele frequency (VAF) dynamics in patients with HER2-negative metastatic breast cancer.\n\nAll enrolled patients will receive antibody-drug conjugate (ADC) therapy for two cycles in Stage 1, with serial ctDNA assessments performed prior to Cycle 1 and Cycle 2. In Stage 2, patients without disease progression will be assigned to different treatment strategies based on the percentage reduction in mean ctDNA VAF.\n\nThe study aims to assess whether ctDNA VAF dynamics can serve as an early biomarker to guide treatment intensification and improve clinical outcomes in metastatic breast cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-75 years；ECOG performance status 0-1； Histologically or cytologically confirmed HER2-negative metastatic breast cancer； At least one measurable lesion per RECIST v1.1； Eligible for ADC therapy； Adequate organ and bone marrow function； Life expectancy ≥3 months； Willingness to provide tumor tissue and blood samples； Signed informed consent\n\nExclusion Criteria:\n\n* Prior treatment with ADC targeting the same antigen and payload；History of grade ≥3 immune-related adverse events； Active or untreated CNS metastases； Active autoimmune disease requiring systemic therapy； Clinically significant cardiovascular disease； Active interstitial lung disease； Active infection including tuberculosis, HIV, hepatitis B or C； Pregnancy or breastfeeding；Investigator-determined conditions that may interfere with study participation'}, 'identificationModule': {'nctId': 'NCT07394218', 'briefTitle': 'ctDNA-guided Treatment Decision-making', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Study on ctDNA-guided Treatment Decision-making for HER2-negative Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'DECISION'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADC + Ivonescimab', 'description': 'Patients with \\<50% mean ctDNA VAF reduction receive ADC combined with ivonescimab.', 'interventionNames': ['Drug: ADC', 'Drug: Ivonescimab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ADC Monotherapy', 'description': 'Patients with \\<50% mean ctDNA VAF reduction receive continued ADC monotherapy.', 'interventionNames': ['Drug: ADC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ADC Monotherapy (ctDNA responder cohort)', 'description': 'Patients with ≥50% mean ctDNA VAF reduction continue ADC monotherapy.', 'interventionNames': ['Drug: ADC']}], 'interventions': [{'name': 'ADC', 'type': 'DRUG', 'description': 'ADC therapy includes sacituzumab govitecan or trastuzumab deruxtecan administered intravenously according to standard dosing schedules. ADC treatment is given in all study stages and continued until disease progression or unacceptable toxicity.', 'armGroupLabels': ['ADC + Ivonescimab', 'ADC Monotherapy', 'ADC Monotherapy (ctDNA responder cohort)']}, {'name': 'Ivonescimab', 'type': 'DRUG', 'description': 'Ivonescimab is administered intravenously at 20 mg/kg every 3 weeks in combination with ADC therapy for patients assigned to the combination treatment arm.', 'armGroupLabels': ['ADC + Ivonescimab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Hongxia WANG', 'role': 'CONTACT', 'email': 'whx365@126.com', 'phone': '86-138196379'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Hongxia Wang', 'investigatorFullName': 'Hongxia Wang', 'investigatorAffiliation': 'Fudan University'}}}}