Ignite Creation Date:
2024-05-06 @ 6:15 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05594095
Status:
RECRUITING
Last Update Posted:
2024-02-06
First Post:
2022-10-13
Brief Title:
SNF Platform Study of HR HER2-advanced Breast Cancer
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Precision Platform Study of HR HER2-advanced Breast Cancer Based on SNF Typing A Prospective Open-label Multi-center Phase II Platform Study
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:
None
Brief Summary:
The purpose of this study is to establish a prospective multi-center platform research based on clinical subtypes to explore precision therapy in patients hormone-receptor-positive HER2-negative advanced breast cancer who had previously used CDK46 inhibitors
Detailed Description:
Participants in this study were hormone-receptor-positive HER2-negative patients with advanced breast cancer who had previously used CDK46 inhibitors Hormone receptor positive HER2 negative was defined as ER positive IHC ER positive percentage 10 or PR positive IHC PR positive percentage 10 and HER2 negative IHC- Or IHC but FISHCISH-
The Department of Pathology and the Key Laboratory of Breast Cancer of Fudan University Shanghai Cancer Center conducted digital pathological typing of the biopsy pathology of metastatic lesions of all participants If the pathology of metastatic lesions could not be obtained the digital pathological typing was performed according to the pathology of primary lesions According to the digital pathological types of biopsy tissue and peripheral blood ctDNA the patients were divided into four precise subtypes SNF1 SNF2 SNF3 and SNF4 At the same time the negative control group was randomly set by subtype stratification at 21 In different SNF types patients were divided into 7 subcohorts according to the genetic PANEL results
The Department of Pathology and the Key Laboratory of Breast Cancer of Fudan University Shanghai Cancer Center conducted digital pathological typing of the biopsy pathology of metastatic lesions of all participants If the pathology of metastatic lesions could not be obtained the digital pathological typing was performed according to the pathology of primary lesions According to the digital pathological types of biopsy tissue and peripheral blood ctDNA the patients were divided into four precise subtypes SNF1 SNF2 SNF3 and SNF4 At the same time the negative control group was randomly set by subtype stratification at 21 In different SNF types patients were divided into 7 subcohorts according to the genetic PANEL results
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