Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT04985058
Status:
RECRUITING
Last Update Posted:
2025-05-18
First Post:
2021-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real-world Data in Patients With Breast Cancer Treated With Abemaciclib
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}, 'targetDuration': '30 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2021-07-26', 'studyFirstSubmitQcDate': '2021-07-26', 'lastUpdatePostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'Through the completion of the study, for an average of 6 months', 'description': 'the time from treatment initiation to either the first documented disease progression or death from any cause'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 96 months', 'description': 'The time from treatment initiation to patient death or last contact'}, {'measure': 'Efficacy of the digital support through personalised support in patients with BC', 'timeFrame': 'Up to 30 months'}, {'measure': 'Toxicity rate', 'timeFrame': 'Up to 30 months', 'description': 'Adverse events from the time from treatment initiation to disease progression, patient death or last contact'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['abemaciclib', 'real-world data'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '40805239', 'type': 'DERIVED', 'citation': 'Fountzilas E, Aravantinou-Fatorou E, Dadouli K, Economopoulou P, Tryfonopoulos D, Vernadou A, Vorrias E, Vagionas A, Nikolaidi A, Karageorgopoulou S, Koumarianou A, Boukovinas I, Mauri D, Kokkali S, Christopoulou A, Tsoukalas N, Assi A, Spathas N, Kosmidis P, Koutras A, Fountzilas G, Psyrri A. Real-World Toxicity and Effectiveness Study of Abemaciclib in Greek Patients with Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer: A Multi-Institutional Study. Cancers (Basel). 2025 Jul 31;17(15):2543. doi: 10.3390/cancers17152543.'}]}, 'descriptionModule': {'briefSummary': 'The present study will assess real-world clinical outcomes and adverse events from treatment with endocrine therapy combined with abemaciclib in patients with HR-positive, HER2-negative advanced breast cancer.', 'detailedDescription': 'Protocol was amended in November 2021, after the recent FDA approval of abemaciclib in the adjuvant setting. On October 12, 2021, FDA approved abemaciclib with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor -positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score ≥20%. Our study will now include real-world data on efficacy and toxicity of abemaciclib in the adjuvant setting as well. 2-negative advanced breast cancer. Patients who are enrolled and the patients to be enrolled will refer to a dedicated online platform (CARE ACROSS platform) where they can register their side-effects of cancer and the treatment received at frequent intervals. Patients will be randomized in the platform in two arms with an allocation 1:1(automatically by the platform). After every report of their side-effects, patients in Arm A will receive an acknowledgement and suggestion to stay in contact with their clinician. After every report of their side- effects, patients in Arm B will receive an acknowledgment and suggestion to stay in contact with their clinician; additionally they will receive personalised support (as a few word text) for each side-effect reported. Clinicians involved in the trial will refer patients (upon enrollment or to those already enrolled) to a dedicated online platform. Patients will sign up by entering their patient ID and their email address (and picking their password for security).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with histologically confirmed HR-positive, HER2-negative breast cancer treated with abemaciclib in combination with endocrine therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed HR-positive, HER2-negative breast cancer\n* Treated at Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology\n* 18 years or older\n* Any menopausal status\n* Treatment with abemaciclib in combination with endocrine therapy\n* Any endocrine therapy\n* At least two months of treatment with abemaciclib'}, 'identificationModule': {'nctId': 'NCT04985058', 'acronym': 'ENDURANCE', 'briefTitle': 'Real-world Data in Patients With Breast Cancer Treated With Abemaciclib', 'organization': {'class': 'OTHER', 'fullName': 'Hellenic Cooperative Oncology Group'}, 'officialTitle': 'Real-world Clinical Outcome and Toxicity Data in Patients With Breast Cancer Treated With Abemaciclib Combined With Endocrine Therapy: the Experience of the Hellenic Cooperative Oncology Group', 'orgStudyIdInfo': {'id': 'RWD_abemaciclib'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with breast cancer randomised in arm A of digital platform', 'description': 'Patients with breast cancer treated with abemaciclib in combination with endocrine treatment and randomised in Arm A of the digital platform. Patients randomised in arm A will receive a an acknowledgement and suggestion to stay in contact with their clinician.'}, {'label': 'Patients with breast cancer randomised in arm B of digital platform', 'description': 'Patients with breast cancer treated with abemaciclib in combination with endocrine treatment and randomised in Arm B of the digital platform. Patients randomised in arm A will receive a an acknowledgement and suggestion to stay in contact with their clinician; additionally they will receive personalised support (as a few word text) for each side-effect reported.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Elena Fountzilas, MD', 'role': 'CONTACT', 'email': 'fountzila@oncogenome.gr'}], 'facility': 'Hellenic Oncology Cooperative Group', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'Elena Fountzilas, MD, PhD', 'role': 'CONTACT', 'email': 'FOUNTZILA@ONCOGENOME.GR', 'phone': '+306945779709'}, {'name': 'Areti Stamboliou', 'role': 'CONTACT', 'email': 'a_stampoliou@hecog.ondsl.gr', 'phone': '+302106912520', 'phoneExt': '23'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hellenic Cooperative Oncology Group', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}