Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-29 @ 9:10 AM
Study NCT ID:
NCT06067503
Status:
RECRUITING
Last Update Posted:
2025-04-22
First Post:
2023-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers to Detect Endocrine Therapy Resistance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D018275', 'term': 'Carcinoma, Lobular'}, {'id': 'D009360', 'term': 'Neoplastic Cells, Circulating'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073890', 'term': 'Liquid Biopsy'}, {'id': 'D000072078', 'term': 'Positron Emission Tomography Computed Tomography'}], 'ancestors': [{'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': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D049268', 'term': 'Positron-Emission Tomography'}, {'id': 'D014055', 'term': 'Tomography, Emission-Computed'}, {'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}, {'id': 'D064847', 'term': 'Multimodal Imaging'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D011877', 'term': 'Radionuclide Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003947', 'term': 'Diagnostic Techniques, Radioisotope'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2023-09-19', 'studyFirstSubmitQcDate': '2023-09-27', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants who have decreased FFNP uptake on PET/CT in response to endocrine therapy', 'timeFrame': 'baseline, 4 weeks'}, {'measure': 'Number of Participants who have decrease in circulating tumor cell estrogen signaling in response to endocrine therapy', 'timeFrame': 'baseline, 4 weeks', 'description': 'Baseline level and on-treatment CTC ESR1 and estrogen regulated gene expression will be evaluated as well as endocrine-resistance associated mutations including ESR1 (though rare in this patient population) and PGR.'}, {'measure': 'Number of Participants who have a decrease in concentration of Circulating Tumor DNA in response to endocrine therapy', 'timeFrame': 'baseline, 4 weeks'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival (PFS) for 6 months', 'timeFrame': 'up to 6 months'}, {'measure': 'Correlation coefficients', 'timeFrame': 'up to 6 months', 'description': 'Correlate baseline levels and dynamic on treatment changes in estrogen signaling as measured by FFNP-PET/CT and CTC liquid biopsy with clinical response to endocrine therapy and progression-free survival in patients with ER/PR+ metastatic LBC.'}, {'measure': 'Adverse Events within 24 hours of FFNP infusion', 'timeFrame': 'a 24 hour period up to 7 days pre-treatment, a 24 hour period 4 weeks after the first infusion'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endocrine Therapy Resistance', 'circulating tumor cell', 'liquid biopsy'], 'conditions': ['Metastatic Cancer', 'Breast Cancer', 'Lobular Breast Carcinoma']}, 'descriptionModule': {'briefSummary': 'This pilot observational study is being done to identify possible biomarkers of response to endocrine therapy in patients with ER/PR+ metastatic lobular breast cancer (LBC) starting new endocrine therapy. 18F-fluorofuranylnorprogesterone Positron Emission Tomography/Computed Tomography (FFNP-PET/CT) and liquid biopsies will be performed at baseline and after 4 weeks of treatment. Baseline levels and dynamic on-treatment changes in estrogen signaling as measured by FFNP-PET/CT and circulating tumor cell (CTC) liquid biopsy will be correlated with clinical response to endocrine therapy and progression-free survival in the above cohort of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Willing to provide informed consent\n2. Individuals at least 18 years of age\n3. Have biopsy-proven ER/PR-positive (defined as ER ≥1 percent and PR ≥1 percent by IHC) and HER2-negative advanced or metastatic LBC starting new standard of care endocrine therapy\n4. Adequate organ function as indicated by standard laboratory tests (CBC, liver function tests or CMP) allowing for systemic breast cancer treatment per treating oncologist\n5. Patients with evaluable bone-only disease that is lytic or mixed lytic-sclerotic are eligible\n6. Willing to comply with all study procedures and be available for the duration of the study\n7. Disease may be measurable by RECIST 1.1 criteria or non-measurable. Lesion size must be at least 1cm. If only bone lesions present, they should be lytic or mixed lytic-sclerotic. If only liver lesions present, patient is not eligible.\n\nExclusion Criteria:\n\n1. Patients with active brain metastases\n2. Patients with liver-only disease are not eligible due to high background liver activity related to the radiopharmaceutical's hepatobiliary route of elimination\n3. Unable to lie flat during or tolerate PET/CT\n4. Patients with a history of allergic reaction attributable to compounds of similar chemical or biologic composition to FFNP\n5. Presence of liver failure as judged by patient's treating physician\n6. Individuals who are pregnant, lactating, or planning on becoming pregnant during the study\n7. Not suitable for study participation due to other reasons at the discretion of the investigators\n8. Patients with progesterone-receptor negative disease defined as PR \\<1 percent by IHC"}, 'identificationModule': {'nctId': 'NCT06067503', 'briefTitle': 'Biomarkers to Detect Endocrine Therapy Resistance', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Integrating Minimally Invasive Biomarkers of Estrogen Signaling to Detect Endocrine Therapy Resistance in Metastatic Invasive Lobular Breast Cancer', 'orgStudyIdInfo': {'id': '2023-1103'}, 'secondaryIdInfos': [{'id': 'Protocol Version 10/2/2023', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'SMPH/MEDICINE/HEM-ONC', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'UW23076', 'type': 'OTHER', 'domain': 'OnCore ID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants with ER/PR+ metastatic lobular breast cancer (LBC)', 'interventionNames': ['Drug: 18F-fluorofuranylnorprogesterone', 'Device: Liquid Biopsy', 'Device: Positron Emission Tomography/Computed Tomography']}], 'interventions': [{'name': '18F-fluorofuranylnorprogesterone', 'type': 'DRUG', 'otherNames': ['FFNP'], 'description': 'The dose of the investigational imaging agent, FFNP, is approximately 7 millicurie (mCi) (259 megabecquerels (MBq)), IV slow infusion over approximately two minutes followed by saline flush.', 'armGroupLabels': ['Participants with ER/PR+ metastatic lobular breast cancer (LBC)']}, {'name': 'Liquid Biopsy', 'type': 'DEVICE', 'otherNames': ['Circulating Tumor Cells (CTC)'], 'description': '20ml of whole blood will be collected into two Ethylenediaminetetraacetic acid (EDTA) tubes at each timepoint, CTCs are isolated using the microfluidic Versatile Exclusion-based Rare Sample Analysis (VERSA) platform that integrates CTC capture with RNA extraction on a single chip using Exclusion-Based Sample Preparation (ESP) technology', 'armGroupLabels': ['Participants with ER/PR+ metastatic lobular breast cancer (LBC)']}, {'name': 'Positron Emission Tomography/Computed Tomography', 'type': 'DEVICE', 'otherNames': ['PET/CT'], 'description': 'FFNP drug in combination with PET/CT scans to image participant', 'armGroupLabels': ['Participants with ER/PR+ metastatic lobular breast cancer (LBC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UW Carbone Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'centralContacts': [{'name': 'Cancer Connect', 'role': 'CONTACT', 'email': 'clinicaltrials@cancer.wisc.edu', 'phone': '800-622-8922'}], 'overallOfficials': [{'name': 'Marina Sharifi, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UW Carbone Cancer Center'}]}, 'ipdSharingStatementModule': {'timeFrame': 'up to 7 years after the completion of the primary endpoint', 'ipdSharing': 'YES', 'description': 'Data from this study may be requested from other researchers up to 7 years after the completion of the primary endpoint by contacting the University of Wisconsin Carbone Cancer Center (UWCCC)', 'accessCriteria': 'UWCCC Cancer Connect: clinicaltrials@cancer.wisc.edu'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}