Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513364
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
Neoadjuvant Chemotherapy With WH002 in Women With HER2-negative Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase Ib Randomized Parallel Study of Comparing WH002 With Paclitaxel Both Sequential of Epirubicin and Cyclophosphamide As Neoadjuvant Treatment of Women With HER2-Negative Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the safety and efficacy of bi-weekly WH002Paclitaxel Medium and Long Chain Fat Emulsion InjectionCholesterol Bound vs Paclitaxel both followed by bi-weekly Epirubicin and Cyclophosphamide as neoadjuvant treatment in women with HER2-negative breast cancer
Detailed Description:
This study is a multicenter randomized open-label positive-drug parallel-controlled phase Ib trial The primary aim of this study was to compare the safety efficacy and pharmacokinetics of a dose-dense regimen of bi-weekly WH002 followed by bi-weekly epirubicin and cyclophosphamide ddWH002-ddEC versus bi-weekly Paclitaxel followed by bi-weekly EC ddP-ddEC as neoadjuvant treatment in women with HER2-negative high-risk early-stage and locally advanced breast cancer Patients randomly assigned to ddP-ddEC received premedication with oral prednisolone 12 and 6 hours before paclitaxel IV dexchlorpheniramine and cimetidine or ranitidine 30 minutes before paclitaxel Whereas all of these premedication was not required in the ddWH002-ddEC group before receiving WH002
Eligible subjects are those with biopsy-confirmed HER2-negative breast cancer as verified by the research center and whose tumor staging as determined by imaging falls into the categories of early high-risk T1c-2 N1 T2 N0 or locally advanced T1c-2 N2-3 T3-4 N0-3 Upon fulfilling all inclusion and exclusion criteria participants will be randomized in a 11 ratio to either the WH002 followed by EC group Group A or the Paclitaxel followed by EC group Group BStratified randomization between the two groups based on tumor molecular subtypes
Luminal type HER2-negative ER or progesterone receptor positive
Triple-negative HER2-negative ER and progesterone receptor negative
Eligible subjects are those with biopsy-confirmed HER2-negative breast cancer as verified by the research center and whose tumor staging as determined by imaging falls into the categories of early high-risk T1c-2 N1 T2 N0 or locally advanced T1c-2 N2-3 T3-4 N0-3 Upon fulfilling all inclusion and exclusion criteria participants will be randomized in a 11 ratio to either the WH002 followed by EC group Group A or the Paclitaxel followed by EC group Group BStratified randomization between the two groups based on tumor molecular subtypes
Luminal type HER2-negative ER or progesterone receptor positive
Triple-negative HER2-negative ER and progesterone receptor negative
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