Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-02-24 @ 3:17 PM
Study NCT ID:
NCT02473120
Status:
COMPLETED
Last Update Posted:
2020-07-30
First Post:
2015-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of ESR1 Mutations in Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-29', 'studyFirstSubmitDate': '2015-06-08', 'studyFirstSubmitQcDate': '2015-06-12', 'lastUpdatePostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of ESR1 mutations', 'timeFrame': 'up to 24 months', 'description': 'Determination of the frequency of ESR1 mutation in patient who have a clinical and/or a radiological progression disease'}], 'secondaryOutcomes': [{'measure': 'Frequency of progression without ESR1 mutations', 'timeFrame': 'up to 24 months', 'description': 'Determination of frequency of patient with a progression disease and without any ESR1 mutations'}, {'measure': 'Time between introduction of aromatase inhibitor and detection of ESR1 mutations', 'timeFrame': 'up to 24 months', 'description': 'Time between introduction of aromatase inhibitor and detection of ESR1 mutations by digital PCR'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['metastatic', 'ESR1', 'aromatase inhibitor', 'breast cancer'], 'conditions': ['Metastatic Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '32466779', 'type': 'DERIVED', 'citation': 'Clatot F, Perdrix A, Beaussire L, Lequesne J, Levy C, Emile G, Bubenheim M, Lacaille S, Calbrix C, Augusto L, Guillemet C, Alexandru C, Fontanilles M, Sefrioui D, Burel L, Guenot S, Richard D, Sarafan-Vasseur N, Di Fiore F. Risk of early progression according to circulating ESR1 mutation, CA-15.3 and cfDNA increases under first-line anti-aromatase treatment in metastatic breast cancer. Breast Cancer Res. 2020 May 28;22(1):56. doi: 10.1186/s13058-020-01290-x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the frequency ESR1 mutations by Digital PCR in patient with metastatic breast cancer.', 'detailedDescription': 'Breast cancer is the most common cancer in woman. Aromatase inhibitors have demonstrated a real efficacy however a resistance to treatment exists.\n\nESR1 mutations appear like involved in the mechanism of resistance to aromatase inhibitors treatment.\n\nThe purpose of the study is to determine the frequency ESR1 mutations by Digital PCR in patient with metastatic breast cancer.\n\nThe significance of the Digital PCR technique will be determined first in plasma issued from healthy volunteers.\n\nAt the initiation of aromatase inhibitors treatment patient with metastatic breast cancer will be included in the study. During their follow-up visit every 3 months), their status towards their disease will be collected and a plasma will be collected too.\n\nWhen the patient progress clinically or radiologically the plasma concomitant to this progression will be analysed by Digital PCR to detect ESR1 mutations.\n\nThe patient will be followed during 2 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Woman aged superior to 18 years old\n* Inform consent signed\n* Metastatic breast cancer or loco-regionnaly advanced breast cancer\n* Inoperable\n* With an indication to treat with aromatase inhibitor\n* Treatment with aromatase inhibitors innitiated at the inclusion or at least 6 months before inclusion with a stable disease\n* Without precedent treatment or with treatment by chemotherapy/tamoxifen/faslodex or aromatase inhibitors in a adjuvant treatment and with a time frame of 2 years between last treatment with aromatase inhibitors and metastatic evolution\n* Treatment by aromatase inhibitors alone or in combination with a targeted therapy (trastuzumab +/- pertuzumab, bevacizumab, everolimus)\n\nExclusion Criteria:\n\n* No inform consent signed\n* Patient under guardianship, curatorship\n* Psychosocial disorder\n* No affiliated or beneficiary of a social benefit system'}, 'identificationModule': {'nctId': 'NCT02473120', 'acronym': 'FMER', 'briefTitle': 'Study of ESR1 Mutations in Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Centre Henri Becquerel'}, 'officialTitle': 'Determination of ESR1 Mutations by Digital PCR During Aromatase Inhibitor Treatment in Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'CHB 15.01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Determination of ESR1 mutations', 'description': 'Blood sample will be collected every 3 months during two years to determine ESR1 mutations', 'interventionNames': ['Biological: Determination of ESR1 mutations']}], 'interventions': [{'name': 'Determination of ESR1 mutations', 'type': 'BIOLOGICAL', 'description': 'Blood sample prelevement. Plasma issued from patient with metastatic breast cancer will be analysed at progression by Digital PCR to detect ESR1 mutations', 'armGroupLabels': ['Determination of ESR1 mutations']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76038', 'city': 'Rouen', 'country': 'France', 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'overallOfficials': [{'name': 'Anne Perdrix, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Henri Becquerel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Henri Becquerel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}