Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417801
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-13
Brief Title:
Prevalence of Emerging Treatment-induced Mutations in Metastatic ER-positive Breast Cancer
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
PANGEIA-2 Prevalence of Emerging Treatment-induced Mutations in metastaticER Positive Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-09
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:
Pangeia-2
Brief Summary:
Observational study on prevalence of emerging ESR1 mutations in liquid biopsy in two cohorts of patients with breast cancer with and without prior therapies in metastatic setting in comparison with patients baseline ESR1 mutation status as defined by tissue profiling
Detailed Description:
This is a prospective observational biomarker cohort study Biomarkers GS Focus Liquid Breast liquid biopsy sequencing assay covers mutations in ESR1 PIK3CA AKT1 PTEN ERBB2 BRCA1 BRCA2 PALB2 and parallel GS Focus Breast tissue sequencing assay performed in baseline tissue biopsy from primary tumor or metastatic lesion not exposed to any systemic therapy cover same gene panel
Biomarker assessment will be carried out by NGS methodology in both liquid biopsy and baseline tissue biopsy Both strategies consider a custom panel covering PIK3CA AKT1 PTEN ESR1 BRCA1 BRCA2 PALB2 ERBB2 genes
NGS panels were internally validated and presented sensitivity specificity and accuracy of 10000 with a limit of detection of 05 VAF for liquid biopsy panel and sensitivity specificity and accuracy of 10000 with a limit of detection of 5 VAF for tissue panel Basically DNA is extracted from tissue samples FFPE and plasma using QIASymphony extractions kits An input of 10 and 100 ng is required for liquid biopsy and tissue respectively NGS libraries is prepared using QIAseq Targeted DNA Custom Panel QIAGEN Sequencing is performed in Illumina platform NextSeq for liquid biopsy and MiSeq for tissue samples in paired-end 2x 150 cycles
Biomarker assessment will be carried out by NGS methodology in both liquid biopsy and baseline tissue biopsy Both strategies consider a custom panel covering PIK3CA AKT1 PTEN ESR1 BRCA1 BRCA2 PALB2 ERBB2 genes
NGS panels were internally validated and presented sensitivity specificity and accuracy of 10000 with a limit of detection of 05 VAF for liquid biopsy panel and sensitivity specificity and accuracy of 10000 with a limit of detection of 5 VAF for tissue panel Basically DNA is extracted from tissue samples FFPE and plasma using QIASymphony extractions kits An input of 10 and 100 ng is required for liquid biopsy and tissue respectively NGS libraries is prepared using QIAseq Targeted DNA Custom Panel QIAGEN Sequencing is performed in Illumina platform NextSeq for liquid biopsy and MiSeq for tissue samples in paired-end 2x 150 cycles
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