Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06143553
Status:
RECRUITING
Last Update Posted:
2023-11-22
First Post:
2023-11-16
Brief Title:
Paclitaxel Polymeric Micelles for Injection Versus TPC on the Treatment of HER2-negative Metastatic Breast Cancer MBC
Sponsor:
Shanghai Yizhong Pharmaceutical Co Ltd
Organization:
Shanghai Yizhong Pharmaceutical Co Ltd
Study Overview
Official Title:
A Randomized Controlled Phase Ⅲ Study of Paclitaxel Polymeric Micelles for Injection Versus Physicians ChoiceTPC in Human Epidermal Growth Factor Receptor 2-negative HER2- Metastatic Breast Cancer MBC Subjects Who Have Failed at Least Two Previous Chemotherapy Regimens
Status:
RECRUITING
Status Verified Date:
2023-01
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 multicenter randomized open parallel positive control study compares the clinical efficacy and safety of paclitaxel polymeric micelles for injection with TPC in HER2- MBC subjects who have failed 2 to4 previous chemotherapy regimens
Treatment Protocol Subjects are randomized into paclitaxel polymeric micelles for injection group and the Physicians Choice TPC group by the proportion of 11 Randomization is stratified according to three factors number of lines of previous treatment for metastatic disease 2 or 34 lines receptor status triple-negative non-triple-negative and visceral metastasis yesno
Progression-free survival PFS is the main efficacy indicator in this study Treatment Group Subjects are given paclitaxel polymeric micelles for injection three weeks constitutes one cycle of treatment
Control Group Physicians Choice Group subjects are given Eribulin Mesilate injection or capecitabine tablets or gemcitabine hydrochloride for injection or vinorelbine tartrate injection or paclitaxel albumin-bound Three or four weeks constitutes one cycle of treatment
If subject does not develop disease progression after 6 cycles of dosing the subject continues treatment until disease progression RECIST 11 or develops an intolerable toxicity initiation of a new anti-cancer drug withdrawal from the study death or loss of follow-up
Superiority design is used in this study progression-free survival PFS is the main efficacy indicator Assuming α 00249unilateral adjusted test level power80 the median PFS of the treatment group is 60 months the median PFS of the control group is 37 months the enrollment period is 12 months and the study period is 24 months Using PASS version 110 for calculation a total of 152 subjects 76 in each group are required to meet the statistical significance between the treatment group and the control group In consideration of case expulsion enlarged by 10 a total of 168 subjects 84 in each group are required
Treatment Protocol Subjects are randomized into paclitaxel polymeric micelles for injection group and the Physicians Choice TPC group by the proportion of 11 Randomization is stratified according to three factors number of lines of previous treatment for metastatic disease 2 or 34 lines receptor status triple-negative non-triple-negative and visceral metastasis yesno
Progression-free survival PFS is the main efficacy indicator in this study Treatment Group Subjects are given paclitaxel polymeric micelles for injection three weeks constitutes one cycle of treatment
Control Group Physicians Choice Group subjects are given Eribulin Mesilate injection or capecitabine tablets or gemcitabine hydrochloride for injection or vinorelbine tartrate injection or paclitaxel albumin-bound Three or four weeks constitutes one cycle of treatment
If subject does not develop disease progression after 6 cycles of dosing the subject continues treatment until disease progression RECIST 11 or develops an intolerable toxicity initiation of a new anti-cancer drug withdrawal from the study death or loss of follow-up
Superiority design is used in this study progression-free survival PFS is the main efficacy indicator Assuming α 00249unilateral adjusted test level power80 the median PFS of the treatment group is 60 months the median PFS of the control group is 37 months the enrollment period is 12 months and the study period is 24 months Using PASS version 110 for calculation a total of 152 subjects 76 in each group are required to meet the statistical significance between the treatment group and the control group In consideration of case expulsion enlarged by 10 a total of 168 subjects 84 in each group are required
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