Viewing Study NCT03439046



Ignite Creation Date: 2024-05-06 @ 11:07 AM
Last Modification Date: 2024-10-26 @ 12:40 PM
Study NCT ID: NCT03439046
Status: COMPLETED
Last Update Posted: 2024-02-23
First Post: 2018-01-29

Brief Title: Study of the Molecular Features of Postmenopausal Women With HR HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and in Patients With a PIK3CA Mutation on Second-line Treatment With Alpelisib Plus Fulvestrant
Sponsor: Novartis Pharmaceuticals
Organization: Novartis

Study Overview

Official Title: A Phase IIIb Open-label Local Multicenter Study of the Molecular Features of Postmenopausal Women With Hormone Receptor-positive HR HER2-negative Advanced Breast Cancer on First-line Treatment With Ribociclib Plus Letrozole and in Patients With a PIK3CA Mutation on Second-line Treatment With Alpelisib Plus Fulvestrant BioItaLEE
Status: COMPLETED
Status Verified Date: 2024-07
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: BioItaLEE
Brief Summary: The purpose of this clinical trial is to study of the molecular features of postmenopausal women with hormone receptor-positive HR HER2-negative advanced breast cancer on first-line treatment with ribociclib and letrozole and in patients with a PIK3CA mutation on second-line treatment with alpelisib plus fulvestrant
Detailed Description: The main purpose of this local multicenter study is to investigate genetic and gene expression alterations in tumor prior to and following progression on ribociclib during core phase and then prior to and following progression on alpelisib and thus identify patterns of mutations how they evolve and their association with CDK46 inhibition and outcomes such as sustained response or early progression The study also aims to evaluate pharmacogenomics and its association with adverse events frequency and severity drug-drug interactions and clinical outcomes

Finally the study will also generate additional long-term safety and efficacy data in this specific Italian population

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
2017-004176-62 EUDRACT_NUMBER None None