Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-29 @ 9:19 AM
Study NCT ID:
NCT05054166
Status:
COMPLETED
Last Update Posted:
2021-09-23
First Post:
2021-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Everolimus-containing Chemotherapy in HER2- mBC Patients With PI3K/AKT/mTOR Mutations Study
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-13', 'studyFirstSubmitDate': '2021-09-02', 'studyFirstSubmitQcDate': '2021-09-13', 'lastUpdatePostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'The PFS was defined as the interval from the date of taking the everolimus-containing chemotherapy to the date of the first occurrence of disease progression or death from any cause,whichever came first, assessed up to 24 months.', 'description': 'Progression free survival'}]}, 'conditionsModule': {'conditions': ['Breast Cancer', 'PI3K/AKT/mTOR Pathway Mutation', 'Everolimus']}, 'descriptionModule': {'briefSummary': 'The study aimed to investigate the efficacy of the everolimus-containing chemotherapy in metastatic breast cancer patients with PI3K/AKT/mTOR mutations.14 cases of HER2- metastatic breast cancer patients with PI3K/AKT/mTOR mutations treated with everolimus-containing chemotherapy were retrospectively analyzed.The genetic profile in PI3K/AKT/mTOR pathway was studied.', 'detailedDescription': 'The PI3K/AKT/mTOR pathway is frequently altered in breast cancer. Everolimus is a selective inhibitor of mammalian target of Rapamycin (mTOR).The benefit of everolimus in metastatic breast cancer patients with PI3K/AKT/mTOR mutations remains unclear, especially in TNBC patients. The study aimed to investigate the efficacy of the everolimus-containing chemotherapy in metastatic breast cancer patients with PI3K/AKT/mTOR mutations.\n\n14 cases of HER2- metastatic breast cancer participants with PI3K/AKT/mTOR mutations treated with everolimus-containing chemotherapy were retrospectively analyzed.The genetic profile in PI3K/AKT/mTOR pathway was studied.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '66 Years', 'minimumAge': '29 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HER2- metastatic breast cancer patients with PI3K/AKT/mTOR mutations treated with everolimus-containing chemotherapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with HER2- metastatic breast cancer\n2. Patients with PI3K/AKT/mTOR mutation\n\nExclusion Criteria:\n\n1. Patients treated with endocrinotherapy and everolimus.\n2. The efficacy evaluation could not be available.'}, 'identificationModule': {'nctId': 'NCT05054166', 'briefTitle': 'Efficacy of Everolimus-containing Chemotherapy in HER2- mBC Patients With PI3K/AKT/mTOR Mutations Study', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang Cancer Hospital'}, 'officialTitle': 'Efficacy of Everolimus-containing Chemotherapy in HER2 Negative Metastatic Breast Cancer Patients With PI3K/AKT/mTOR Mutations: A Retrospective Study', 'orgStudyIdInfo': {'id': 'EVE-CWM-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention, it was a retrospective study.', 'type': 'OTHER', 'description': 'This study aimed to retrospectively investigate the efficacy of the everolimus-containing chemotherapy in metastatic breast cancer patients with PI3K/AKT/mTOR mutations.There was no intervention.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Xiao-jia Wang, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zhejiang Cancer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Cancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Wen-Ming Cao', 'investigatorAffiliation': 'Zhejiang Cancer Hospital'}}}}