Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT06243432
Status:
UNKNOWN
Last Update Posted:
2024-04-24
First Post:
2024-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Estrogen Receptors and HER2 Levels' Expression in Luminal Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-23', 'studyFirstSubmitDate': '2024-01-24', 'studyFirstSubmitQcDate': '2024-02-02', 'lastUpdatePostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival (PFS)', 'timeFrame': 'Through study completion, an average of 1 year".', 'description': 'PFS of HR+/HER2- breast cancer patients who received endocrine treatment plus CDK4/6 inhibitor as first line treatment for metastatic disease, categorized according to estrogen and progesterone receptor levels and HER2 expression status (HER2 0,1+ or 2+ FISH negative).'}], 'secondaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': 'Through study completion, an average of 1 year".', 'description': 'ORR according to estrogen and progesterone receptor levels and HER2 expression status (HER2 0,1+ or 2+ FISH negative).'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Through study completion, an average of 1 year".', 'description': 'OS according to estrogen and progesterone receptor levels and HER2 expression status (HER2 0,1+ or 2+ FISH negative).'}, {'measure': 'Incidence of Adverse Events (AEs)', 'timeFrame': 'Through study completion, an average of 1 year".', 'description': 'AEs related to the treatment and evaluated according to CTCAE v5.0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Breast Carcinoma']}, 'descriptionModule': {'briefSummary': "CYCLHER is a retrospective observational multicentric italian study aimed to evaluate the correlation between hormone receptors (HR) and HER2 immunohistochemistry (IHC) levels and treatment'response in patients affected by advanced breast cancer treated with first line CDK4/6 inhibitor plus endocrine therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HR+/HER2- advanced breast cancer patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 yo\n* Histological diagnosis of HR+/HER2- advanced breast cancer\n* Immunohistochemical HER2 negative evaluation (0, 1+ or 2+ FISH-)\n* Immunohistochemical expression levels of estrogen and progesterone receptors\n* First line CDK4/6 inhibitor plus endocrine therapy stared up to 12/31/2020\n* Signing of informed consent approved by local Ethic Committee\n\nExclusion Criteria:\n\n* Absence of clinical and pathological data that would compromise the definition of the study endpoints\n* HER2 positive (ICH 2+ and FISH positive or HER2 3 +) or triple negative disease\n* Previous chemotherapy for treatment of metastatic disease'}, 'identificationModule': {'nctId': 'NCT06243432', 'acronym': 'CYCLHER', 'briefTitle': "Estrogen Receptors and HER2 Levels' Expression in Luminal Metastatic Breast Cancer", 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': "Estrogen Receptors and HER2 Levels' Expression in Luminal Metastatic Breast Cancer: Correlation to Therapeutic Efficacy of Cycline-Dependent Kinase Inhibitors(CDK4/6) as First Line Treatment. CYCLHER Study", 'orgStudyIdInfo': {'id': '5519'}}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandra Fabi', 'role': 'CONTACT', 'email': 'alessandra.fabi@policlinicogemelli.it', 'phone': '+390630157337'}, {'name': 'Alessandra Fabi', 'role': 'CONTACT', 'email': 'alessandra.fabi@policlinicogemelli.it', 'phone': '+390630156124'}], 'facility': 'Fondazione Policlinico A. Gemelli - IRCCS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Alessandra Fabi, MD', 'role': 'CONTACT', 'email': 'alessandra.fabi@policlinicogemelli.it', 'phone': '0039 0630157337'}], 'overallOfficials': [{'name': 'Alessandra Fabi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}