Paclitaxel Polymeric Micelles for Injection Versus TPC on the Treatment of HER2-negative Metastatic Breast Cancer (MBC).
Status:
Recruiting
Trial end date:
2025-07-01
Target enrollment:
Participant gender:
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 to≤4 previous chemotherapy regimens.
Treatment Protocol: Subjects are randomized into paclitaxel polymeric micelles for injection
group and the Physician's Choice (TPC) group by the proportion of 1:1. Randomization is
stratified according to three factors: number of lines of previous treatment for metastatic
disease (2 or 3/4 lines), receptor status (triple-negative, non-triple-negative), and
visceral metastasis (yes/no).
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: Physician's 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 1.1) 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 = 0.0249(unilateral, adjusted test level), power=80%, the
median PFS of the treatment group is 6.0 months, the median PFS of the control group is 3.7
months, the enrollment period is 12 months, and the study period is 24 months. Using PASS
(version 11.0) 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.