Ignite Creation Date:
2024-05-06 @ 9:30 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT02990845
Status:
TERMINATED
Last Update Posted:
2023-02-22
First Post:
2016-12-01
Brief Title:
Pembrolizumab and Exemestane Leuprolide in Premenopausal HR HER2- Locally Advanced or Metastatic Breast Cancer
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
A Pilot Study of Pembrolizumab and Exemestane Leuprolide in Premenopausal Hormone Receptor Positive HER2 Negative Locally Advanced or Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The enrolment became difficult as most of the premenopausal women decided to receive ovarian ablation for health insurance reimbursement for CDK46 inhibitor for the first-line treatment making them ineligible for joining the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEER
Brief Summary:
This is an open-label single-arm multicenter pilot study of pembrolizumab exemestane and leuprolide for subjects being resistant for front-line hormonal therapy for inoperable locally advanced or metastatic hormonal receptor positive HR Human epidermal growth factor receptor 2 HER2 negative breast cancer All the patients will be included in the final tolerability and preliminary efficacy analysis The efficacy objectives including PFS overall response rate ORR clinical benefit rate CBR and duration of response DOR Adverse effects will be recorded according to CTCAE v40
Detailed Description:
None
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