Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
Study NCT ID:
NCT06621459
Status:
RECRUITING
Last Update Posted:
2024-10-01
First Post:
2024-09-27
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retrospective Observational Study of the Safety and Toxicity Management of Abemaciclib in Combination with Adjuvant Hormone Therapy in Patients with RH+ ,HER2-nonoveramplified Breast Cancer, Real-life Data (MONARCHE29)
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-26', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-27', 'studyFirstSubmitDate': '2024-09-27', 'studyFirstSubmitQcDate': '2024-09-27', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the average dose of abemaciclib received over 6 months.', 'timeFrame': 'over 6 months', 'description': 'The primary criterion was the average dose of abemaciclib received over 6 months.\n\nThe average dose received was defined as: the dose administered per day, multiplied by the duration of treatment, taking into account periods of interruptions and dose reductions, divided by 183 days (6 months). This quantity can be expressed in mg/day or as a percentage of the maximum dose (full dose, without interruption).\n\nThis criterion will be used to divide the population into two groups. The threshold of two-thirds of the maximum dose was chosen, corresponding to the reduction of the first therapeutic adjustment step. It allows separation into a group receiving a so-called full dose, corresponding to two-thirds or more of the maximum dose, and a group receiving a reduced dose, corresponding to less than two-thirds of the maximum dose. This calculation allows the identification of patients who had at least one dose adjustment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Abemaciclib', 'Adjuvant Therapy', 'Antineoplastic Combined Chemotherapy Protocols', 'Breast Cancer', 'Real-life', 'Real Word Data'], 'conditions': ['Brest Cancer', 'Abemaciclib', 'Adjuvant Therapy', 'Antineoplastic Combined Chemotherapy Protocols', 'Breast Neoplasms']}, 'descriptionModule': {'briefSummary': 'Overall survival at 8 years under treatment for localized hormone-dependent breast cancer is 93.3% (1). Adjuvant therapy, especially hormone therapy, helps reduce the risk of recurrence.\n\nHowever, the risk of relapse remains significant, estimated at around 20% according to studies. The SOFT study, which compares the type of hormone therapy used in premenopausal patients, estimates a relapse risk of 21.1% at 8 years (1), especially when there is initial lymph node involvement. In fact, in cases of lymph node involvement, the cumulative relapse rate at 10 years after stopping hormone therapy ranges between 19% and 36% (2), and the risk of death from breast cancer 20 years after stopping hormone therapy is estimated at 28% to 49% (2).\n\nCDK4/6 inhibitors first demonstrated their efficacy at the metastatic stage. Abemaciclib improved median survival to 46.7 months compared to a median of 37.3 months with hormone therapy alone (Monarch 2 (3) and Monarch 3 (4)). Palbociclib showed in PALOMA-2 (5) an improvement in progression-free survival (24.8 months versus 14.5 months) without an improvement in overall survival. Ribociclib, in turn, demonstrated in MONALEESA 2 (6) an improvement in PFS (25.3 months versus 16 months) and in overall survival (63.9 months versus 51.4 months). These treatments have become the standard first-line treatment for patients with RH+ HER2 non-amplified breast cancer.\n\nGiven the results in advanced lines, CDK4/6 inhibitors have been the subject of studies in localized breast cancer, particularly in this high-risk population where the recurrence rate remains significant.\n\nThe MONARCH-E study, published on September 20, 2020 (7), led to the approval of Abemaciclib by European authorities at the time of the initial publication (median follow-up of 15.4 months) and to reimbursement starting in May 2023 after a second interim analysis (8) in this at-risk population, with a 5.6% reduction in relapse risk after 42 months of follow-up compared to hormone therapy alone.\n\nIt is crucial to clearly define the at-risk population in order to offer them treatment intensification while maintaining a satisfactory quality of life. The group benefiting from Abemaciclib presented grade III toxicity in 43% of cases and grade IV toxicity in 2.5%.\n\nReal-world data are needed to better understand the management and toxicity of this treatment.', 'detailedDescription': 'TARGET POPULATION\n\nPatients with high-risk RH+ HER2 non-amplified breast cancer according to the criteria of the MONARCH-E study, specifically:\n\nEither ≥ 4 pALN (positive axillary lymph nodes)\n\nOr 1-3 pALN and at least one of the following criteria:\n\n* Tumor size ≥ 5 cm\n* Or histological grade 3 PRIMARY OBJECTIVE\n\nTolerance of treatment with ABEMACICLIB in combination with hormone therapy\n\nSECONDARY OBJECTIVES\n\nRecurrence-free survival Safety and tolerance of treatment with ABEMACICLIB Impact of dose reduction on treatment efficacy Incidence and management of digestive toxicity Incidence of hematological toxicity Incidence of pulmonary toxicity (with radiotherapy) Tolerance data in patients over 75 years Incidence and causes of permanent discontinuation of ABEMACICLIB Quality of life data\n\nPRIMARY EVALUATION CRITERION\n\nDose intensity of ABEMACICLIB treatment at 6 months SECONDARY EVALUATION CRITERIA\n\nMedian duration of ABEMACICLIB treatment Cumulative dose of treatment Frequency and severity of side effects according to CTCAE V5 classification IDFS IDFS correlated with dose reduction METHODOLOGY Multicenter retrospective study based on data\n\nSTATISTICS For the demographic analysis of the study population, quantitative variables will be represented by their mean ± standard deviation or their median ± Q1-Q3 interval depending on their distribution. Qualitative variables will be represented by the number and proportion of individuals within each category.\n\nIf necessary, quantitative variables will be compared using the Student\\'s t-test or the Wilcoxon test depending on their distribution. Qualitative variables will be compared using the Chi-square or Fisher test depending on their distribution.\n\nINCLUSION CRITERIA\n\nAdult patient Patient who has received adjuvant ABEMACICLIB in combination with hormone therapy\n\nPatient with localized RH+ HER2 non-amplified breast cancer and eligible for treatment with ABEMACICLIB according to the recommendations of the MA (Marketing Authorization) as defined below:\n\n≥4 ipsilateral positive axillary lymph nodes OR\n\n1 to 3 ipsilateral positive axillary lymph node(s) with at least one of the following two criteria: histological grade 3 or primary tumor size ≥5 cm\n\nEXCLUSION CRITERIA\n\nPatients under legal protection (guardianship, trusteeship, etc.) Refusal to participate\n\nNUMBER OF PATIENTS Cohort consisting of all patients meeting the inclusion criteria during the study period, approximately 30 patients.\n\nTIMELINE Inclusion duration: 23 months\n\nData collection period (retrospective between May 2023 and June 2025):\n\nStudy completion time (i.e., sending non-objections + data entry): 25 months\n\nFUNDING No funding'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with high-risk RH+ HER2 non-amplified breast cancer according to the criteria of the MONARCH-E study, specifically:\n\nEither ≥ 4 pALN (positive axillary lymph nodes)\n\nOr 1-3 pALN and at least one of the following criteria:\n\n* Tumor size ≥ 5 cm\n* Or histological grade 3', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient\n* Patient who has received adjuvant ABEMACICLIB in combination with hormone therapy\n* Patient with localized RH+ HER2 non-amplified breast cancer and eligible for treatment with ABEMACICLIB according to the recommendations of the MA (Marketing Authorization) as defined below:\n\n * 4 ipsilateral positive axillary lymph nodes OR\n\n 1. to 3 ipsilateral positive axillary lymph node(s) with at least one of the following two criteria: histological grade 3 or primary tumor size ≥5 cm\n\nExclusion Criteria:\n\n* Patients under legal protection (guardianship, trusteeship, etc.)\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT06621459', 'acronym': 'MONARCHE29', 'briefTitle': 'Retrospective Observational Study of the Safety and Toxicity Management of Abemaciclib in Combination with Adjuvant Hormone Therapy in Patients with RH+ ,HER2-nonoveramplified Breast Cancer, Real-life Data (MONARCHE29)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Retrospective Observational Study of the Safety and Toxicity Management of Abemaciclib in Combination with Adjuvant Hormone Therapy in Patients with RH+ ,HER2-nonoveramplified Breast Cancer, Real-life Data', 'orgStudyIdInfo': {'id': '29BRC24.0244 - MONARCHE29'}}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Quentin Laune', 'role': 'CONTACT', 'email': 'quentin.laune@chu-brest.fr', 'phone': '+33298223333'}], 'facility': 'Chu Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}], 'centralContacts': [{'name': 'Emmanuelle RENAUD', 'role': 'CONTACT', 'email': 'emmanuelle.renaud@chu-brest.fr', 'phone': '0298223396', 'phoneExt': '+33'}, {'name': 'Quentin LAUNE', 'role': 'CONTACT', 'email': 'quentin.laune@chu-brest.fr'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available beginning three years and ending fifteen years following the final study report completion', 'ipdSharing': 'YES', 'description': 'All collected data that underlie results in a publication', 'accessCriteria': 'Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}