Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06382948
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-04-05
Brief Title:
Elacestrant Everolimus in Patients ERHER2- ESR1mut Advanced Breast Cancer Progressing to ET and CDK46i
Sponsor:
MedSIR
Organization:
MedSIR
Study Overview
Official Title:
A Randomized Phase 3 Double-Blind Placebo-Controlled Study of Elacestrant Plus Everolimus Versus Elacestrant in Patients With ERHER2- ESR1mut Advanced Breast Cancer Progressing to Endocrine Therapy and CDK46 Inhibitors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADELA
Brief Summary:
This trial will study a type of advanced breast cancer ABC defined as endocrine receptor ER-positivehuman epidermal growth factor receptor 2HER2-negative and estrogen receptor 1 ESR1-mutated Patients will be treated with elacestrant a compound that acts as a selective estrogen receptor degrader and everolimus or placebo a kinase inhibitor indicated for the treatment of postmenopausal women with advanced hormone receptor-positive HER2-negative breast cancer
The main purpose of the study is to analyze the efficacy to find out how effective a treatment is of elacestrant plus everolimus therapy in patients who have ER-positiveHER2-negative ESR1-mutated ABC progressing to endocrine therapy and cyclin-dependent kinase 46 CDK46 inhibitor The efficacy of elacestrant plus everolimus combination will be determined by assessing the period from elacestrant plus everolimus or placebo treatment initiation until to the first occurrence of disease progression unacceptable toxicity death or discontinuation from the study treatment for any other reason whichever occurs first defined as progression free survival
Rigorous eligibility criteria based on specific co-morbidities and clinicopathologic features of their disease have been designed to minimize the risk of patients participating in this study The anticipated favorable clinical benefits of elacestrant combined with everolimus are projected to outweigh the risks of this treatment This study will be performed in full compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ICH and all applicable local Good Clinical Practice GCP and regulations
The main purpose of the study is to analyze the efficacy to find out how effective a treatment is of elacestrant plus everolimus therapy in patients who have ER-positiveHER2-negative ESR1-mutated ABC progressing to endocrine therapy and cyclin-dependent kinase 46 CDK46 inhibitor The efficacy of elacestrant plus everolimus combination will be determined by assessing the period from elacestrant plus everolimus or placebo treatment initiation until to the first occurrence of disease progression unacceptable toxicity death or discontinuation from the study treatment for any other reason whichever occurs first defined as progression free survival
Rigorous eligibility criteria based on specific co-morbidities and clinicopathologic features of their disease have been designed to minimize the risk of patients participating in this study The anticipated favorable clinical benefits of elacestrant combined with everolimus are projected to outweigh the risks of this treatment This study will be performed in full compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ICH and all applicable local Good Clinical Practice GCP and regulations
Detailed Description:
Upon meeting all selection criteria a total of 240 patients will be enrolled
After signing the Informed Consent Form ICF patients will be randomized ratio 11 as follows
Interventional Arm Arm A N120 Patients will receive 345 mg of elacestrant and 75 mg of everolimus orally once daily
Control Arm Arm B N120 Patients will receive elacestrant at 345 mg orally once daily plus everolimus placebo
Patients will be stratified by presence of visceral metastases yes versus no and duration of prior CDK46 inhibitor-based therapy 12 months versus 12 months Patients progressing to CDK46 inhibitor-based therapy in the adjuvant setting will be stratified as patients with a duration of prior CDK46 inhibitor-based therapy 12 months
Patients will receive study treatment in 28-day cycles until documented disease progression death unacceptable toxicity or discontinuation from the study treatment for any other reason whichever occurs first
Patients discontinuing the study treatment period will enter a post-treatment follow-up period during which survival and new anti-cancer therapy information will be collected every 3 months 14 days from the last dose of IMPs until the End of Study EoS defined as 12 months after last patient is randomized unless premature termination of the trial For patients who discontinue the study treatment for reasons other than disease progression tumor assessments will be conducted following the frequency of the study until the start of a new anti-cancer treatment death or disease progression
After signing the Informed Consent Form ICF patients will be randomized ratio 11 as follows
Interventional Arm Arm A N120 Patients will receive 345 mg of elacestrant and 75 mg of everolimus orally once daily
Control Arm Arm B N120 Patients will receive elacestrant at 345 mg orally once daily plus everolimus placebo
Patients will be stratified by presence of visceral metastases yes versus no and duration of prior CDK46 inhibitor-based therapy 12 months versus 12 months Patients progressing to CDK46 inhibitor-based therapy in the adjuvant setting will be stratified as patients with a duration of prior CDK46 inhibitor-based therapy 12 months
Patients will receive study treatment in 28-day cycles until documented disease progression death unacceptable toxicity or discontinuation from the study treatment for any other reason whichever occurs first
Patients discontinuing the study treatment period will enter a post-treatment follow-up period during which survival and new anti-cancer therapy information will be collected every 3 months 14 days from the last dose of IMPs until the End of Study EoS defined as 12 months after last patient is randomized unless premature termination of the trial For patients who discontinue the study treatment for reasons other than disease progression tumor assessments will be conducted following the frequency of the study until the start of a new anti-cancer treatment death or disease progression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-512926-27-00 | CTIS | None | None |