Ignite Creation Date:
2024-05-06 @ 6:20 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05625087
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2022-11-14
Brief Title:
Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive HR Non-HER2 Expressing HER2- Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
A ctDNA Screening Program in Patients With HR HER2- Metastatic Breast Cancer for Detection of High-risk Relapse Patients on Any CDK46 Inhibitor and a Randomised Phase II Study Comparing Alpelisib Combined With Fulvestrant to Ribociclib Combined With Fulvestrant in Patients With Persistent Targetable PIK3CA Mutations
Status:
RECRUITING
Status Verified Date:
2024-06
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:
SAFIR 03
Brief Summary:
After an initial screening phase SAFIR 03 - SCREENING to identify patients with blood circulating mutated-PIK3CA tumours persistent patients will be enrolled in the treatment phase of SAFIR 03 SAFIR 03 - ARRIBA that was designed as a randomised open-label multicentre phase II study for comparison of alpelisib to ribociclib in combination with fulvestrant as the continuation of the CDK46 inhibitor-fulvestrant strategy in terms of progression-free survival PFS
Detailed Description:
INDICATION The population eligible to the screening phase is composed of all women or men with HR HER2- metastatic breast cancer who are eligible for first-line treatment with a cyclin-dependent kinases CDK 46 inhibitor combined with fulvestrant and a luteinizing hormone realeasing hormone LH-RH analogue in men and premenopausal women in the context of the standard healthcare management The screening will identify patients with high risk of relapse on any CDK46 inhibitor thanks to ctDNA kinetic between baseline and 4 weeks of treatment The purpose is to early adapt the therapeutic intervention for ctDNA no drop patient to prevent from relapse This study will propose an intervention for PIK3CA mutated patients with alpelisib vs ribociclib Other therapeutic approaches might be proposed to patients with wild type PIK3CA through other protocols
The randomised study phase will include patients with persistent mutations on exons 4 9 or 20 of PIK3CA ctDNA after 4 weeks of treatment with any CDK46 inhibitor-fulvestrant in first-line setting
The randomised study phase will include patients with persistent mutations on exons 4 9 or 20 of PIK3CA ctDNA after 4 weeks of treatment with any CDK46 inhibitor-fulvestrant in first-line setting
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU CT | OTHER | 2022-502372-22-00 | None |