Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-01 @ 5:12 PM
Study NCT ID:
NCT01210768
Status:
UNKNOWN
Last Update Posted:
2021-11-23
First Post:
2010-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Pegylated Liposomal Doxorubicin and Cyclophosphamide in Her2-negative Stage I and II Breast Cancer Patients
Sponsor:
TTY Biopharm
Organization:
Study Overview
Official Title:
A Phase II Randomized Study of Pegylated Liposomal Doxorubicin, Cyclophosphamide Versus Epirubicin-Cyclophosphamide as Adjuvant Chemotherapy in Her2-negative Stage I and II Breast Cancer Patients
Status:
UNKNOWN
Status Verified Date:
2021-11
Last Known Status:
ACTIVE_NOT_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:
Primary objective:
* To evaluate the disease-free survival (DFS) in the two randomized arms after therapy with LC vs. EC in chemo-naive Her2-patients with stage I or II breast cancer
Secondary objectives:
* To assess the overall survival (OS)
* To establish the safety profile by assessing the toxicities and tolerability
* To assess the quality of life (QoL)
* To evaluate survival correlation with biomarkers expression.
* To evaluate the disease-free survival (DFS) in the two randomized arms after therapy with LC vs. EC in chemo-naive Her2-patients with stage I or II breast cancer
Secondary objectives:
* To assess the overall survival (OS)
* To establish the safety profile by assessing the toxicities and tolerability
* To assess the quality of life (QoL)
* To evaluate survival correlation with biomarkers expression.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: