Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-03-03 @ 3:38 PM
Study NCT ID:
NCT03161834
Status:
WITHDRAWN
Last Update Posted:
2021-05-21
First Post:
2017-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plasma Circulating Tumor DNA Analyses in ER+ Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009360', 'term': 'Neoplastic Cells, Circulating'}], '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': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '10 mL blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'IRB Study Closure', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-18', 'studyFirstSubmitDate': '2017-05-15', 'studyFirstSubmitQcDate': '2017-05-18', 'lastUpdatePostDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival Prediction', 'timeFrame': 'Through study completion, an average of 3-6 weeks', 'description': 'To evaluate whether increased mutant ESR1 allele fraction in plasma ctDNA 3-6 weeks after initiating salvage endocrine therapy is predictive of progression free survival in patients with ER+ metastatic breast cancer.'}], 'secondaryOutcomes': [{'measure': 'DNA Analysis of Hotspot Mutation Prevalence', 'timeFrame': 'Through study completion, an average of 3-6 weeks', 'description': 'To evaluate the overall spectrum and prevalence of hotspot and non-hotspot ESR1 mutations in plasma ctDNA prior to initiating 2nd, 3rd, or 4th endocrine therapy and after clinical disease progression.'}, {'measure': 'DNA Analysis of Mutation and Radiographic Response Correlation', 'timeFrame': 'Through study completion, an average of 3-6 weeks', 'description': 'Exploratory analysis of whether changes in mutant ESR1 allele fraction in plasma ctDNA at the time of re-staging scans correlates with radiographic response.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DNA', 'Circulating tumor cells'], 'conditions': ['Metastatic Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://unclineberger.org/patientcare/clinical-trials/clinical-trials', 'label': 'UNC Lineberger Comprehensive Cancer Center Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether increased mutant ESR1 allele fraction in plasma ctDNA 3-6 weeks after initiating salvage endocrine therapy is predictive of progression free survival in patients with ER+ metastatic breast cancer.', 'detailedDescription': 'The primary objective of this 110 patient correlative biomarker study is to evaluate whether changes in mutant ESR1 allele fraction in plasma circulating tumor DNA (ctDNA) are predictive of progression-free survival in metastatic ER+ breast cancer patients who are receiving 2nd, 3rd, or 4th line systemic endocrine therapy. A secondary goal of this study is to explore the prevalence and kinetics of hotspot and non-hotspot ctDNA ESR1 mutations in this patient population, prior to initiating a new line of endocrine therapy as well as upon clinical progression, to identify potential mechanisms of resistance. Although initially to be opened at UNC Chapel Hill, our goal is to expand enrollment to include Rex Cancer Center in Raleigh, North Carolina, and collaborating institutions through the Translational Breast Cancer Research Consortium.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Females with ER+ metastatic breast cancer receiving 2nd, 3rd, or 4th line systemic endocrine therapy', 'genderDescription': 'Females with metastatic breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years of age\n* Female gender\n* Biopsy proven diagnosis of breast cancer\n* Stage IV disease diagnosed either by radiographic studies or biopsy\n* ER+ by immunohistochemistry on primary and/or metastatic tissue biopsy (\\>10%)\n* HER2 non-amplified (1+ or below by immunohistochemistry, and/or Her2 FISH \\<2 HER2-to-CEP17 ratio)\n* Progressed on at least one prior line of endocrine therapy for metastatic disease\n* Three or fewer prior endocrine-containing therapies for recurrent/metastatic disease\n* Two or fewer prior lines of cytotoxic chemotherapy for recurrent/metastatic disease\n* Plans to initiate 2nd, 3rd, or 4th line endocrine therapy for metastatic disease\n* Recent re-staging scans within 4 weeks of study enrollment, with radiographically identifiable disease\n* No concurrent or prior diagnosis of malignancy other than breast cancer for the past 5 years. Patients with a history of in situ cancer or basal or localized squamous cell skin cancer remain eligible\n* Intends to pursue treatment as well as clinical and radiographic follow-up at UNC Health Care\n* Signed an institutional review board (IRB)-approved informed consent document for this protocol and HIPAA consent form\n\nExclusion Criteria:\n\n* \\< 18 years of age\n* Tissue biopsies that support the presence of both ER+ and ER- metastatic breast cancer in the same patient\n* Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT03161834', 'briefTitle': 'Plasma Circulating Tumor DNA Analyses in ER+ Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'UNC Lineberger Comprehensive Cancer Center'}, 'officialTitle': 'LCCC 1642: Plasma Circulating Tumor DNA (ctDNA) Analyses in ER+ Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'LCCC 1642'}, 'secondaryIdInfos': [{'id': '16-2952', 'type': 'OTHER', 'domain': 'UNC IRB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Observational', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill Cancer Hospital', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Gaorav P Gupta, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UNC Lineberger Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}