Ignite Creation Date:
2024-05-06 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05949541
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2023-07-09
Brief Title:
Efficacy of Everolimus Combined With First-line Endocrine Therapy for HRHER2- SNF1-subtype Advanced Breast Cancer
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Study of Efficacy of Everolimus Combined With First-line Endocrine Therapy for HRHER2- Open Randomized Phase II
Status:
RECRUITING
Status Verified Date:
2024-02
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:
BCTOP-L-M01
Brief Summary:
This is a randomized controlled open-label phase II study to explore the efficacy and safety of Everolimus in combination with standard first-line endocrine therapy for the HR HER2-SNF1 subtype of advanced breast cancer The study was used to explore the efficacy of Everolimus in combination with standard endocrine therapy
Detailed Description:
A total of 584 patients with luminal breast cancer who received surgery in the breast surgery Department of the Affiliated Cancer Hospital of Fudan University were collected in the early stage All patients could be divided into four categories namely SNF1 classical luminal type SNF2 immune-mediated type SNF1 proliferative type and SNF4 receptor tyrosine kinase-driven type through clustering by the SNF algorithm SNF1 classical luminal type The transcriptional component type is dominated by PAM50 LumA with high PIK3CA mutation and low TP53 mutation By combining artificial intelligence based on HE pathological sections with deep learning methodology molecular typing can be effectively distinguished Prior to enrollment the patients primary lesion or metastasis was classified by molecular classification based on the HE section combined with digital pathology and SNF1 was confirmed to be considered for subsequent enrollment
Receivers will be randomly assigned 11 to either Everolimus plus Standard Endocrine therapy study group or Standard Endocrine therapy control group
Treatment will continue until disease progression intolerable toxicity informed withdrawal or death from any cause
Receivers will be randomly assigned 11 to either Everolimus plus Standard Endocrine therapy study group or Standard Endocrine therapy control group
Treatment will continue until disease progression intolerable toxicity informed withdrawal or death from any cause
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