Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2026-01-01 @ 8:57 AM
Study NCT ID:
NCT07069595
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-02
First Post:
2025-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D018365', 'term': 'Neoplasm, Residual'}, {'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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2025-07-07', 'studyFirstSubmitQcDate': '2025-07-07', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of triple negative breast cancer (TNBC) with molecular residual disease (MRD)', 'timeFrame': 'Up to 3 years after registration', 'description': 'The number of participants with triple negative breast cancer (TNBC) with molecular residual disease (MRD) only recurrence, which is defined as ctDNA positivity without radiographically measurable recurrence, during post-surgery surveillance.'}], 'secondaryOutcomes': [{'measure': 'The time between Circulating tumor DNA (ctDNA) positivity and clinically proven relapse', 'timeFrame': 'Up to 3 years after registration', 'description': 'ctDNA levels will be measured every 6 weeks during adjuvant and/or Dato-DXd therapy and every 12 weeks thereafter.'}, {'measure': 'Duration of Circulating tumor DNA (ctDNA) clearance', 'timeFrame': 'Up to 3 years after registration', 'description': 'Duration of ctDNA clearance will be defined as the time from the first confirmed clearance (for negative test after positive results) to the date of confirmed positivity.'}, {'measure': 'Circulating tumor DNA (ctDNA) clearance with Dato-DXd', 'timeFrame': 'Up to 3 years after registration', 'description': 'ctDNA clearance in participants who receive Dato-DXd will be defined as the proportion of participants who convert from ctDNA positive to negative after initiation of Dato-DXd.'}, {'measure': 'Toxicity of Dato-DXd', 'timeFrame': 'Up to 3 years after registration', 'description': "Toxicity of Dato-DXd treatment will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. NCI-CTCAE is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE."}, {'measure': 'Recurrence Free Survival (RFS) for ctDNA-positive and ctDNA-negative disease.', 'timeFrame': 'Up to 3 years after registration', 'description': 'RFS will be measured from the day of the first circulating tumor DNA (ctDNA) measurement to documented recurrence of disease in participants with ctDNA-positive and ctDNA-negative disease.'}, {'measure': 'Recurrence Free Survival (RFS) - Dato-DXd', 'timeFrame': 'Up to 3 years after registration', 'description': 'RFS will be measured from the day of the first circulating tumor DNA (ctDNA) measurement to documented recurrence of disease in participants who receive Dato-DXd.'}, {'measure': 'Overall Survival (OS) - ctDNA-positive and ctDNA and negative disease.', 'timeFrame': 'Up to 3 years after registration', 'description': 'OS will be measured from the day of the first ctDNA measurement to death from any cause in participants with ctDNA-positive and ctDNA-negative disease.'}, {'measure': 'Overall Survival (OS) - for ctDNA-positive and ctDNA-negative disease.', 'timeFrame': 'Up to 3 years after registration', 'description': 'OS will be measured from the day of the first ctDNA measurement to death from any cause in participants who receive Dato-DXd.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['circulating tumor DNA (ctDNA)', 'surveillance', 'Dato-DXd'], 'conditions': ['Breast Cancer', 'Residual Disease', 'Triple Negative Breast Cancer (TNBC)', 'Stage II/III']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://unclineberger.org/patientcare/clinical-trials/clinical-trials', 'label': 'University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase II, interventional, prospective, single-arm, multi-center study that will enroll patients with stage II/III triple negative breast cancer (TNBC) who have residual cancer burden (RCB) II/III after conventional neoadjuvant chemo-immunotherapy followed by surgery. Technological advances in ctDNA assays have improved both the sensitivity and reliability of molecular residual disease (MRD) detection to enable real-time measurement with clinical-grade assays.\n\nThe primary objective of this study will be to evaluate ctDNA-based MRD status in high-risk, early-stage TNBC patients by defining the proportion of TNBC patients with MRD-only recurrence (ctDNA positive without radiographically measurable recurrence) during post-surgery surveillance. The secondary objectives will evaluate the safety, preliminary efficacy, and survival outcomes of using Dato-DXd in participants with MRD-only TNBC.\n\nDato-DXd is an investigational antibody-drug conjugate (monoclonal antibody specific for TROP2 and a topoisomerase I (Topo-1) inhibitor) that has demonstrated promising efficacy in TNBC patients with a manageable safety profile.', 'detailedDescription': 'Despite treatment advances, patients with II/III triple negative breast cancer (TNBC) residual disease post-neoadjuvant therapy, particularly patients with higher residual cancer burden (RCB II/III), remain at high risk for developing recurrence. Furthermore, early detection of relapse risk, when the residual disease burden is micrometastatic (defined here as undetectable by standard cross-sectional imaging), provides a chance for disease eradication whereas macrometastatic disease (i.e., detectable on standard cross-sectional imaging) is generally considered to be non-curable.\n\nThere are no standard of care (SOC) surveillance strategies for early detection of micrometastatic disease in high-risk TNBC beyond clinical monitoring. Detecting molecular residual disease (MRD) is a promising approach to identifying patients at increased risk of recurrence after definitive therapy, who may benefit from the escalation of their treatment and remain potentially curable with effective systemic therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWritten informed consent was obtained to participate in the study, and HIPAA authorization for the release of personal health information.\n\n* Participant is willing and able to comply with study procedures based on the judgment of the investigator.\n* Age ≥ 18 years at the time of consent.\n* Histological confirmation of TNBC defined by ER/PR \\<10%, HER2 0-1+ by IHC or 2+ by IHC and fluorescence in situ hybridization (FISH) negative.\n* Stage II/III TNBC treated with neoadjuvant systemic therapy AND have residual disease defined as RCB II/III at time of surgery.\n* Baseline staging scans at the discretion of the treating physician and demonstrate no evidence of metastatic disease.\n* The participant must have archival diagnostic tissue and/or surgical resection tissue Available.\n* Participants are willing and able to comply with study procedures based on the judgment of the investigator.\n\nExclusion Criteria:\n\n• Participants are pregnant or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT07069595', 'acronym': 'PREDICT-RD', 'briefTitle': 'PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease', 'organization': {'class': 'OTHER', 'fullName': 'UNC Lineberger Comprehensive Cancer Center'}, 'officialTitle': 'PREDICT-RD: Postoperative Molecular Residual Disease by ctDNA Surveillance in TNBC With Residual Disease', 'orgStudyIdInfo': {'id': 'LCCC2215'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with higher residual cancer burden', 'description': 'Participants with stage II/III triple negative breast cancer (TNBC) and residual disease post-neoadjuvant therapy, particularly patients with higher residual cancer burden (RCB II/III), remain at high risk for developing recurrence.', 'interventionNames': ['Drug: Datopotamab deruxtecan', 'Diagnostic Test: Circulating tumor DNA (ctDNA) testing']}], 'interventions': [{'name': 'Datopotamab deruxtecan', 'type': 'DRUG', 'otherNames': ['Dato-DXd'], 'description': 'Dato-DXd is administered adjuvantly at 6 mg/kg IV for eight cycles.', 'armGroupLabels': ['Patients with higher residual cancer burden']}, {'name': 'Circulating tumor DNA (ctDNA) testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Circulating tumor DNA (ctDNA) testing is a type of biopsy that analyzes fragments of DNA shed by cancer cells into the bloodstream. These fragments, known as ctDNA, can provide valuable information about the genetic makeup of a tumor without needing a traditional tissue biopsy.', 'armGroupLabels': ['Patients with higher residual cancer burden']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'contacts': [{'name': 'Ana Gallegos', 'role': 'CONTACT', 'email': 'ana_gallegos@med.unc.edu', 'phone': '919-984-0000'}, {'name': 'Taylor Pierce', 'role': 'CONTACT', 'email': 'tepierce@email.unc.edu'}, {'name': 'Yara Abdou, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UNC Lineberger Comprehensive Cancer Center', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'centralContacts': [{'name': 'Taylor Pierce', 'role': 'CONTACT', 'email': 'Taylor_Pierce@med.unc.edu', 'phone': '919-984-0000'}], 'overallOfficials': [{'name': 'Yara Abdou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNC Lineberger Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UNC Lineberger Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}, {'name': 'Translational Breast Cancer Research Consortium', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}