Ignite Creation Date:
2024-05-06 @ 4:16 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04920708
Status:
RECRUITING
Last Update Posted:
2023-10-27
First Post:
2021-05-27
Brief Title:
Fulvestrant Ipatasertib and CDK46 Inhibition in Metastatic ERHER2- Breast Cancer Patients Without ctDNA Suppression
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
Royal Marsden NHS Foundation Trust
Study Overview
Official Title:
Randomised Phase II Study of Induction Fulvestrant and CDK46 Inhibition With the Addition of Ipatasertib in Metastatic ERHER2- Breast Cancer Patients Without ctDNA Suppression
Status:
RECRUITING
Status Verified Date:
2023-10
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:
FAIM
Brief Summary:
Analysis of circulating tumour DNA ctDNA found in a patients peripheral blood can identify cancer progression and predict a patients response to therapy By using ctDNA analysis and imaging techniques the FAIM trial aims to determine whether the addition of the experimental drug ipatasertib to a standard combination of the hormone treatment fulvestrant and the targeted agent palbociclib increases progression free survival PFS for patients with hormone-receptor positive and human epidermal growth factor receptor 2 negative HRHER2- breast cancer
Detailed Description:
Circulating tumour DNA ctDNA can be found in the peripheral blood of patients with cancer ctDNA analysis provides a readily available serial source of tumour DNA which can be used to monitor disease and predict a patients response to therapy
Relative changes in ctDNA after 15 days of treatment with palbociclib and fulvestrant has been found to strongly predict progression free survival PFS in hormone-receptor positive and human epidermal growth factor receptor 2 negative HRHER2- breast cancer patients patients without ctDNA suppression after 2 weeks of treatment had a significantly shorter PFS compared to those with ctDNA suppression identifying a group of patients who require additional therapy to prevent early progression
The FAIM trial is a randomised open-label study which will aim to determine whether the addition of ipatasertib to standard of care CDK46 inhibitors fulvestrant increases PFS in patients who lack ctDNA suppression after 15 days of treatment Patients starting standard of care CDK46 inhibitors fulvestrant will have a ctDNA assessment on cycle 1 day 1 C1D1 and cycle 1 day 15 C1D15 Those with high ctDNA levels at C1D15 will be randomised on a 11 basis to either standard of care CDK46 inhibitors fulvestrant or standard of care plus the experimental drug ipatasertib CDK46 inhibitor fulvestrant ipatasertib Patients with ctDNA suppression at C1D15 will continue standard of care fulvestrantCDK46 inhibitor the first 100 patients of this group will be followed for PFS and ctDNA collection Patients without detectable ctDNA on C1D1 will be followed and treated according standard of care the first 50 patients of this group will be followed for PFS overall survival OS time to next treatment and time to chemotherapy Progression free survival will be monitored using RECIST 11
Relative changes in ctDNA after 15 days of treatment with palbociclib and fulvestrant has been found to strongly predict progression free survival PFS in hormone-receptor positive and human epidermal growth factor receptor 2 negative HRHER2- breast cancer patients patients without ctDNA suppression after 2 weeks of treatment had a significantly shorter PFS compared to those with ctDNA suppression identifying a group of patients who require additional therapy to prevent early progression
The FAIM trial is a randomised open-label study which will aim to determine whether the addition of ipatasertib to standard of care CDK46 inhibitors fulvestrant increases PFS in patients who lack ctDNA suppression after 15 days of treatment Patients starting standard of care CDK46 inhibitors fulvestrant will have a ctDNA assessment on cycle 1 day 1 C1D1 and cycle 1 day 15 C1D15 Those with high ctDNA levels at C1D15 will be randomised on a 11 basis to either standard of care CDK46 inhibitors fulvestrant or standard of care plus the experimental drug ipatasertib CDK46 inhibitor fulvestrant ipatasertib Patients with ctDNA suppression at C1D15 will continue standard of care fulvestrantCDK46 inhibitor the first 100 patients of this group will be followed for PFS and ctDNA collection Patients without detectable ctDNA on C1D1 will be followed and treated according standard of care the first 50 patients of this group will be followed for PFS overall survival OS time to next treatment and time to chemotherapy Progression free survival will be monitored using RECIST 11
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?:
False
Is an FDA AA801 Violation?:
None