Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-01-03 @ 2:39 AM
Study NCT ID:
NCT06833502
Status:
RECRUITING
Last Update Posted:
2025-10-20
First Post:
2025-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study of Systemic Screening in Pathologic Node Positive 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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-16', 'studyFirstSubmitDate': '2025-02-13', 'studyFirstSubmitQcDate': '2025-02-13', 'lastUpdatePostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systemic Metastasis', 'timeFrame': 'Baseline and 6 months', 'description': 'Proportion of participants with systemic metastasis at baseline and 6 months.'}], 'secondaryOutcomes': [{'measure': 'Metastasis Treatment', 'timeFrame': 'Up to 12 months', 'description': 'Number of patients receiving surgery, radiation therapy, and/or systemic therapy to manage metastases.'}, {'measure': 'Metastasis Frequency', 'timeFrame': 'Up to 12 months', 'description': 'Proportion of participants with metastasis up to 12 months from baseline CT.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Node-positive Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the frequency of systemic metastasis in node positive breast cancer following chemotherapy and surgery. Participants will be asked to spend about 6 months in this study. Participants will undergo a computed tomography (CT) screening of the thorax, abdomen, and pelvis at baseline prior to adjuvant radiation therapy and another CT screening of the thorax, abdomen, and pelvis at 6 months if the baseline CT is found to be negative.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologic diagnosis of breast cancer with documentation of ER/PR/HER2 status.\n* HR+ will be defined as ER and/or PR ≥ 10%. To be classified as HER2+ disease, overexpression of HER2 by either IHC or in-situ hybridization is necessary as defined by the ASCO / CAP Guidelines27. Triple negative will be classified as ER and PR \\<10% and HER2-.\n* Node positive HER2+ and triple negative breast cancer (ypN+) following receipt of neoadjuvant chemotherapy. HR+/HER2- patients should have ypN2 or ypN3 disease following receipt of neoadjuvant chemotherapy and surgery.\n* Patient must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen. To include HER2 directed therapy for HER2+ patients.\n* Age ≥ 18.\n* Life expectancy ≥ 6 months.\n* Eastern Cooperative Oncology Group performance status 0 to 2.\n* Patients must be able to understand and the willingness to sign an informed consent for study procedures.\n* Ability to understand and stated willingness to comply with all study procedures and availability for the duration of the study.\n\nExclusion Criteria:\n\n* Prior diagnosis of systemic metastases.\n* Patients with prior history of non-breast cancer malignancies should have NED ≥ 2 years excluding adequately treated non-melanoma skin cancer, in situ cancer of the cervix or bladder.\n* Contraindication towards CT IV contrast.\n* Chronic kidney disease stage IV or V or end stage renal disease (CrCl \\<30 ml/min).'}, 'identificationModule': {'nctId': 'NCT06833502', 'briefTitle': 'Phase II Study of Systemic Screening in Pathologic Node Positive Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'H. Lee Moffitt Cancer Center and Research Institute'}, 'officialTitle': 'Phase II Study of Systemic Screening in Pathologic Node Positive Breast Cancer Following Neoadjuvant Chemotherapy and Surgery', 'orgStudyIdInfo': {'id': 'MCC-23433'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Triple negative', 'description': 'Participants diagnosed with triple negative breast cancer.', 'interventionNames': ['Other: CT Scan']}, {'type': 'OTHER', 'label': 'HER2+', 'description': 'Participants diagnosed with HER2+ breast cancer.', 'interventionNames': ['Other: CT Scan']}, {'type': 'OTHER', 'label': 'Hormone receptor (HR)+', 'description': 'Participants diagnosed with hormone receptor (HR)+ breast cancer.', 'interventionNames': ['Other: CT Scan']}], 'interventions': [{'name': 'CT Scan', 'type': 'OTHER', 'description': 'Participants will undergo a screening CT thorax, abdomen, pelvis at baseline prior to adjuvant radiation therapy and additional screening CT thorax, abdomen, and pelvis at 6 months if the baseline CT is found to be negative.', 'armGroupLabels': ['HER2+', 'Hormone receptor (HR)+', 'Triple negative']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kamran Ahmed, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Matthew Mills, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Avan Armaghani, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ricardo Costa, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Roberto Diaz, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Loretta Loftus, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': "Tracey O'Connor, MD", 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hatem Soliman, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Aixa Soyano Muller, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Iman Washington, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'centralContacts': [{'name': 'Rheese Mcnab', 'role': 'CONTACT', 'email': 'Rheese.Mcnab@moffitt.org', 'phone': '813-745-1780'}], 'overallOfficials': [{'name': 'Kamran Ahmed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moffitt Cancer Center'}, {'name': 'Matthew Mills', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moffitt Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lee Moffitt Cancer Center and Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Florida Breast Cancer Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}