Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621459
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
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:
None
Organization:
None
Study Overview
Official 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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MONARCHE29
Brief Summary:
Overall survival at 8 years under treatment for localized hormone-dependent breast cancer is 933 1 Adjuvant therapy especially hormone therapy helps reduce the risk of recurrence
However 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 211 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
CDK46 inhibitors first demonstrated their efficacy at the metastatic stage Abemaciclib improved median survival to 467 months compared to a median of 373 months with hormone therapy alone Monarch 2 3 and Monarch 3 4 Palbociclib showed in PALOMA-2 5 an improvement in progression-free survival 248 months versus 145 months without an improvement in overall survival Ribociclib in turn demonstrated in MONALEESA 2 6 an improvement in PFS 253 months versus 16 months and in overall survival 639 months versus 514 months These treatments have become the standard first-line treatment for patients with RH HER2 non-amplified breast cancer
Given the results in advanced lines CDK46 inhibitors have been the subject of studies in localized breast cancer particularly in this high-risk population where the recurrence rate remains significant
The 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 154 months and to reimbursement starting in May 2023 after a second interim analysis 8 in this at-risk population with a 56 reduction in relapse risk after 42 months of follow-up compared to hormone therapy alone
It 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 25
Real-world data are needed to better understand the management and toxicity of this treatment
However 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 211 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
CDK46 inhibitors first demonstrated their efficacy at the metastatic stage Abemaciclib improved median survival to 467 months compared to a median of 373 months with hormone therapy alone Monarch 2 3 and Monarch 3 4 Palbociclib showed in PALOMA-2 5 an improvement in progression-free survival 248 months versus 145 months without an improvement in overall survival Ribociclib in turn demonstrated in MONALEESA 2 6 an improvement in PFS 253 months versus 16 months and in overall survival 639 months versus 514 months These treatments have become the standard first-line treatment for patients with RH HER2 non-amplified breast cancer
Given the results in advanced lines CDK46 inhibitors have been the subject of studies in localized breast cancer particularly in this high-risk population where the recurrence rate remains significant
The 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 154 months and to reimbursement starting in May 2023 after a second interim analysis 8 in this at-risk population with a 56 reduction in relapse risk after 42 months of follow-up compared to hormone therapy alone
It 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 25
Real-world data are needed to better understand the management and toxicity of this treatment
Detailed Description:
TARGET POPULATION
Patients with high-risk RH HER2 non-amplified breast cancer according to the criteria of the MONARCH-E study specifically
Either 4 pALN positive axillary lymph nodes
Or 1-3 pALN and at least one of the following criteria
Tumor size 5 cm
Or histological grade 3 PRIMARY OBJECTIVE
Tolerance of treatment with ABEMACICLIB in combination with hormone therapy
SECONDARY OBJECTIVES
Recurrence-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
PRIMARY EVALUATION CRITERION
Dose intensity of ABEMACICLIB treatment at 6 months SECONDARY EVALUATION CRITERIA
Median 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
STATISTICS 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
If necessary quantitative variables will be compared using the Studentamp39s 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
INCLUSION CRITERIA
Adult patient Patient who has received adjuvant ABEMACICLIB in combination with hormone therapy
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
4 ipsilateral positive axillary lymph nodes OR
1 to 3 ipsilateral positive axillary lymph nodes with at least one of the following two criteria histological grade 3 or primary tumor size 5 cm
EXCLUSION CRITERIA
Patients under legal protection guardianship trusteeship etc Refusal to participate
NUMBER OF PATIENTS Cohort consisting of all patients meeting the inclusion criteria during the study period approximately 30 patients
TIMELINE Inclusion duration 23 months
Data collection period retrospective between May 2023 and June 2025
Study completion time ie sending non-objections data entry 25 months
FUNDING No funding
Patients with high-risk RH HER2 non-amplified breast cancer according to the criteria of the MONARCH-E study specifically
Either 4 pALN positive axillary lymph nodes
Or 1-3 pALN and at least one of the following criteria
Tumor size 5 cm
Or histological grade 3 PRIMARY OBJECTIVE
Tolerance of treatment with ABEMACICLIB in combination with hormone therapy
SECONDARY OBJECTIVES
Recurrence-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
PRIMARY EVALUATION CRITERION
Dose intensity of ABEMACICLIB treatment at 6 months SECONDARY EVALUATION CRITERIA
Median 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
STATISTICS 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
If necessary quantitative variables will be compared using the Studentamp39s 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
INCLUSION CRITERIA
Adult patient Patient who has received adjuvant ABEMACICLIB in combination with hormone therapy
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
4 ipsilateral positive axillary lymph nodes OR
1 to 3 ipsilateral positive axillary lymph nodes with at least one of the following two criteria histological grade 3 or primary tumor size 5 cm
EXCLUSION CRITERIA
Patients under legal protection guardianship trusteeship etc Refusal to participate
NUMBER OF PATIENTS Cohort consisting of all patients meeting the inclusion criteria during the study period approximately 30 patients
TIMELINE Inclusion duration 23 months
Data collection period retrospective between May 2023 and June 2025
Study completion time ie sending non-objections data entry 25 months
FUNDING No funding
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None