Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2026-01-06 @ 3:19 PM
Study NCT ID:
NCT05398861
Status:
UNKNOWN
Last Update Posted:
2022-06-01
First Post:
2022-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utidelone Combined With Bevacizumab in the Treatment of ≥ 2 Lines of HER-2 Negative Advanced Breast Cancer
Sponsor:
Henan Cancer Hospital
Organization:
Study Overview
Official Title:
A Single-arm, Prospective, Open-label Phase II Clinical Study of Utidelone Combined With Bevacizumab in the Treatment of ≥ 2 Lines of HER-2 Negative Advanced Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
NOT_YET_RECRUITING
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 study is a prospective, single-arm, open-label phase II study to evaluate the efficacy and safety of the combination of Utidelone and bevacizumab regimen in patients with ≥ 2 lines of HER-2 negative advanced breast cancer.
Detailed Description:
Patients included were patients with ≥ 2 lines of HER2-negative advanced breast cancer who had previously failed taxanes and/or anthracyclines, or patients with hormone receptor-positive HER2-negative advanced breast cancer who had progressed after at least 1 line of prior endocrine therapy.
This study used a Simon two-stage design. 71 subjects will be enrolled using the optimal design.
This study used a Simon two-stage design. 71 subjects will be enrolled using the optimal design.
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?: