Ignite Creation Date:
2024-05-06 @ 8:29 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02742051
Status:
COMPLETED
Last Update Posted:
2021-09-23
First Post:
2016-04-07
Brief Title:
A Trial of Neoadjuvant Everolimus Plus Letrozole Versus FEC in Women With ER-positive HER2-negative Breast Cancer
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
A Randomised Pilot Study of Neoadjuvant Everolimus Plus Letrozole Compared With FEC in Postmenopausal Patients With ER-positive HER2-negative Breast Cancer
Status:
COMPLETED
Status Verified Date:
2021-09
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:
None
Brief Summary:
This open randomized pilot feasibility trial is to evaluate the feasibility and effect of neoadjuvant everolimus plus letrozole versus neoadjuvant fluorouracil epirubicin plus cyclophosphamide FEC in treating postmenopausal women with ER-positive HER2-negative breast cancer Forty postmenopausal stage M0 ER-positive HER2-negative invasive breast cancer women who had a primary tumor 2cm by imaging or an axillary lymph node 2cm by imaging were randomly 11 enrolled to receive neoadjuvant everolimus plus letrozole for 18 weeks or neoadjuvant FEC for 6 cycles before surgery The primary objective is to determine the feasibility of neoadjuvant everolimus plus letrozole in postmenopausal patients with ER-positive HER2-negative breast cancer Secondary aims are to compare the ultrasound response rate pathological complete response pCR rate breast-conserving surgery rate toxicities and changes in the percentages or counts of peripheral blood CD4 T cells CD8 T cells tumor-specific CTLs T helper cells Th regulatory T cells Treg and NK cells and changes in tumor Ki67 index pre- versus post- neoadjuvant therapy
Detailed Description:
None
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