Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-04-14 @ 10:50 AM
Study NCT ID:
NCT04608357
Status:
RECRUITING
Last Update Posted:
2025-01-20
First Post:
2020-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrated Patient Avatars for Guiding Systemic Therapy Treatments in Metastatic Breast Cancer Patients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062005', 'term': 'Biopsy, Large-Core Needle'}], 'ancestors': [{'id': 'D001707', 'term': 'Biopsy, Needle'}, {'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'needle core biopsies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-17', 'studyFirstSubmitDate': '2020-10-23', 'studyFirstSubmitQcDate': '2020-10-28', 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the tumor take rate in PDX', 'timeFrame': '7-10 days', 'description': 'perform a feasibility study to determine the tumor take rate(s) in PDXs generated from needle core biopsies collected from metastatic breast cancer patients'}], 'secondaryOutcomes': [{'measure': 'Compare response rates of PDXs & with that of the patient from whom the PDX was derived', 'timeFrame': '8 to 16 weeks', 'description': "The response of PDXs will be compared to the patient's response to systemic therapy, as measured using the objective response rate."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['metastatic breast cancer', 'systemic therapy', 'needle core biopsy', 'PDXovo', 'feasibility study', 'tumor take rate'], 'conditions': ['Breast Cancer', 'Breast Neoplasms', 'Metastatic Breast Cancer', 'Cancer, Breast']}, 'referencesModule': {'references': [{'pmid': '38969866', 'type': 'DERIVED', 'citation': 'Grafinger OR, Hayward JJ, Meng Y, Geddes-McAlister J, Li Y, Mar S, Sheng M, Su B, Thillainadesan G, Lipsman N, Coppolino MG, Trant JF, Jerzak KJ, Leong HS. Cancer cell extravasation requires iplectin-mediated delivery of MT1-MMP at invadopodia. Br J Cancer. 2024 Sep;131(5):931-943. doi: 10.1038/s41416-024-02782-9. Epub 2024 Jul 5.'}]}, 'descriptionModule': {'briefSummary': 'The investigators propose to use clinically validated patient avatar technology ("PDXovo") that can test multiple drugs against patients\' cancers to identify the most promising systemic therapy for each individual.', 'detailedDescription': "The primary goal of this feasibility study is to determine the percentage of patients for whom PDXs are successfully generated within 7-10 days. This will give the investigators an indication of the success rate for providing patients with actionable information if this PDX technology were to be implemented in the clinic. Since the PDXs will also receive the same drug as the patient, there is an opportunity to assess the agreement between the clinical response and the PDX response.\n\nAs a secondary goal, the response of PDXs will be compared to the patient's response to systemic therapy, as measured using the objective response rate at 12 weeks +/- 4 weeks (ORR, measured using RECIST 1.1 criteria)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with metastatic breast cancer irrespective of subtype prior to receiving either front-line or subsequent line systemic therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18+.\n2. Metastatic breast cancer irrespective of subtype.\n3. Measurable disease as per RECIST 1.1 criteria.\n4. Metastatic disease involving the lymph nodes and/or visceral organs is required.\n5. Willingness to undergo a biopsy prior to the start of planned systemic therapy.\n\nExclusion Criteria:\n\n1. Lack of feasibility to obtain a core biopsy of a metastatic site other than the bone (e.g. a metastatic lesion cannot be safely sampled due to proximity to vasculature).\n2. Inability to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT04608357', 'briefTitle': 'Integrated Patient Avatars for Guiding Systemic Therapy Treatments in Metastatic Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'Integrated Patient Avatars for Guiding Systemic Therapy Treatments: "Intuition-Free" Decisions in Metastatic Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'SUN-2252'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Needle Core Biopsies', 'type': 'DIAGNOSTIC_TEST', 'description': 'Not an interventional study'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Katarzyna J Jerzak, MD MSc FRCPC', 'role': 'CONTACT', 'email': 'katarzyna.jerzak@sunnybrook.ca', 'phone': '416-480-6100', 'phoneExt': '5248'}, {'name': 'Hon S Leong', 'role': 'CONTACT', 'email': 'hon.leong@sri.utoronto.ca', 'phone': '416-480-6100', 'phoneExt': '5748'}], 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Katarzyna J Jerzak, MD MSc FRCPC', 'role': 'CONTACT', 'email': 'katarzyna.jerzak@sunnybrook.ca', 'phone': '416-480-6100', 'phoneExt': '5248'}, {'name': 'Hon S Leong', 'role': 'CONTACT', 'email': 'hon.leong@sri.utoronto.ca', 'phone': '416-480-6100', 'phoneExt': '5748'}], 'overallOfficials': [{'name': 'Katarzyna J Jerzak, MD MSc FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Health Sciences Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'AFP Innovation Fund', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Oncologist & Associate Scientist', 'investigatorFullName': 'Dr. Katarzyna Jerzak', 'investigatorAffiliation': 'Sunnybrook Health Sciences Centre'}}}}