Ignite Creation Date:
2024-05-06 @ 2:08 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04227327
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-04-13
First Post:
2019-12-17
Brief Title:
Study Evaluating Abemaciclib Aromatase Inhibitors in HR HER2- Advanced Breast Cancer Patients HERMIONE-7
Sponsor:
University of Milano Bicocca
Organization:
University of Milano Bicocca
Study Overview
Official Title:
A Phase 2 Open Label Multicenter Single Arm Trial Evaluating the Activity and Safety of Abemaciclib Aromatase Inhibitors AIs After 1st-line Treatment With High-Dose Fulvestrant in Hormone-Receptor-Positive HR Human-Epidermal-Growth-factor-negative HER2- Advanced Breast Cancer Patients The HERMIONE-7 Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-04
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:
HERMIONE-7
Brief Summary:
The HERMIONE-7 trial is a phase II single-arm open-label multicenter study in HR HER2- advanced breast cancer patients who have received HD-FUL as first-line endocrine treatment for their metastatic disease Patients will receive aromatase inhibitors plus Abemaciclib
Detailed Description:
Hormone receptor positive tumors represent the most common form of breast cancer and account for most of the deaths from the disease Endocrine therapy ET represents the main initial therapeutic strategy for these patients and has been associated with significant clinical benefits in the majority of them
Key-Topics for rationale
Fulvestrant an Estrogen-Receptor ER antagonist with no known agonist effects suppresses estrogen signaling by binding to and degrading the ER Fulvestrant was approved as a monthly 250 mg dosing regimen based on TTP data demonstrating non-inferiority versus anastrozole in postmenopausal women whose advanced breast cancer had progressed during prior anti-estrogen therapy
The international CONFIRM trial compared Fulvestrant 500 mg High-Dose Fulvestrant HD-FUL Fulvestrant 500 mg every month with an additional 500 mg loading dose on Day 14 of the first month with the monthly 250 mg dose and demonstrated that HD-FUL mg was associated with improved progression-free survival PFS and overall survival OS in postmenopausal women with ER-positive ER advanced breast cancer whose disease had recurred or progressed after prior endocrine therapy
The FALCON study evaluated the efficacy and safety of HD-FUL in comparison to anastrozole in HR HER2- recurrent or metastatic breast cancer MBC patients Median duration of PFS with HD-FUL was 166 months 95 CI 1383-2099 in the whole population and 223 months 95 CI 1662-3279 in the non-visceral one Grade 3 or worse adverse events were reported by 51 22 of 228 patients receiving HD-FUL
Palbociclib Abemaciclib and Ribociclib Fulvestrant are superior to Fulvestrant alone in terms of PFS PALOMA-3 95 vs 46 months MONARCH-2 164 vs 93 MONALEESA-3 205 vs 128 in patients who have received prior endocrine therapy for advanced disease or have relapsed during or within 1 month from adjuvant therapy
A descriptive study analyzed European treatment patterns for HR-positive MBC patients in real-world clinical practice in the years 2004 - 2013 showed that Fulvestrant was the initial therapy for advanced disease in 08 - 26 of the patients However the ongoing real-world GIM-13 AMBRA study showed that in Italy this percentage has grown up to 30
At the moment no data are available regarding the activity of CDK 46 inhibitors in patients treated with HD-FUL as 1st-line therapy nor are there ongoing trials in this setting
The aim of this study is to describe the activity of Abemaciclib aromatase inhibitors AIs - letrozole or anastrozole in HD-FUL pre-treated MBC patients in terms of Clinical Benefit Rate CBR
This is a phase II single-arm open-label multicenter study in HR HER2- advanced breast cancer patients who have received HD-FUL as first-line endocrine treatment for their metastatic disease Patients will receive aromatase inhibitors plus Abemaciclib Abemaciclib will be administered orally at 150 mg twice daily until evidence of disease recurrence or other discontinuation criteria are met whichever occurs first together with AIs as per specific product instructions The Simons optimal two-stage design will be used for the conduction of the trial
Key-Topics for rationale
Fulvestrant an Estrogen-Receptor ER antagonist with no known agonist effects suppresses estrogen signaling by binding to and degrading the ER Fulvestrant was approved as a monthly 250 mg dosing regimen based on TTP data demonstrating non-inferiority versus anastrozole in postmenopausal women whose advanced breast cancer had progressed during prior anti-estrogen therapy
The international CONFIRM trial compared Fulvestrant 500 mg High-Dose Fulvestrant HD-FUL Fulvestrant 500 mg every month with an additional 500 mg loading dose on Day 14 of the first month with the monthly 250 mg dose and demonstrated that HD-FUL mg was associated with improved progression-free survival PFS and overall survival OS in postmenopausal women with ER-positive ER advanced breast cancer whose disease had recurred or progressed after prior endocrine therapy
The FALCON study evaluated the efficacy and safety of HD-FUL in comparison to anastrozole in HR HER2- recurrent or metastatic breast cancer MBC patients Median duration of PFS with HD-FUL was 166 months 95 CI 1383-2099 in the whole population and 223 months 95 CI 1662-3279 in the non-visceral one Grade 3 or worse adverse events were reported by 51 22 of 228 patients receiving HD-FUL
Palbociclib Abemaciclib and Ribociclib Fulvestrant are superior to Fulvestrant alone in terms of PFS PALOMA-3 95 vs 46 months MONARCH-2 164 vs 93 MONALEESA-3 205 vs 128 in patients who have received prior endocrine therapy for advanced disease or have relapsed during or within 1 month from adjuvant therapy
A descriptive study analyzed European treatment patterns for HR-positive MBC patients in real-world clinical practice in the years 2004 - 2013 showed that Fulvestrant was the initial therapy for advanced disease in 08 - 26 of the patients However the ongoing real-world GIM-13 AMBRA study showed that in Italy this percentage has grown up to 30
At the moment no data are available regarding the activity of CDK 46 inhibitors in patients treated with HD-FUL as 1st-line therapy nor are there ongoing trials in this setting
The aim of this study is to describe the activity of Abemaciclib aromatase inhibitors AIs - letrozole or anastrozole in HD-FUL pre-treated MBC patients in terms of Clinical Benefit Rate CBR
This is a phase II single-arm open-label multicenter study in HR HER2- advanced breast cancer patients who have received HD-FUL as first-line endocrine treatment for their metastatic disease Patients will receive aromatase inhibitors plus Abemaciclib Abemaciclib will be administered orally at 150 mg twice daily until evidence of disease recurrence or other discontinuation criteria are met whichever occurs first together with AIs as per specific product instructions The Simons optimal two-stage design will be used for the conduction of the trial
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