Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Metastatic Breast Cancer

Sponsor
Shanghai Yizhong Pharmaceutical Co., Ltd.
Study ID
NCT06143553
Phase
PHASE3
Status
Recruiting
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Conditions

  • Metastatic Breast Cancer (MBC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel Polymeric Micelles for Injection — DRUG
    Subjects are given 300 mg/m2 of Paclitaxel Polymeric Micelles for Injection without special infusion device,intravenously administrated for ≥ 3 hours.Three weeks constituted one course of treatment.
  • Eribulin Mesilate injection — DRUG
    Subjects are given 1.4 mg/m2 of Eribulin Mesilate injection on days 1 and 8 of the 21-day cycle.
  • Capecitabine Tablets — DRUG
    Subjects are given 1000-1250mg/m2 of Capecitabine Tablets on days 1 to 14 of the 21-day cycle ,and twice a day (once in the morning and once in the evening; Total daily dose 2000-2500mg/m2).
  • Gemcitabine Hydrochloride for Injection — DRUG
    Subjects are given 800-1200mg/m2 of Gemcitabine Hydrochloride for Injection on days 1, 8 and 15 of the 28-day cycle.
  • Vinorelbine Tartrate Injection — DRUG
    Subjects are given 25mg/m2 of Vinorelbine Tartrate Injection every first day of the week.
  • Paclitaxel (albumin-bound) — DRUG
    Subjects are given 260mg/m2 of Paclitaxel (albumin-bound) on day 1 of the 21-day cycle,intravenous administration for more than 30 minutes.

Study Details

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.

Key Dates

Start date
Sep 25, 2023
Status verified
Aug 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
168 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Paclitaxel Polymeric Micelles for Injection
    300mg/m2 of Paclitaxel Polymeric Micelles for Injection is intravenously administrated for ≥ 3 hours without special infusion device. The frequency of administration is once every 3 weeks (Q3W), and 3 weeks constitutes a treatment cycle.
  • Active Comparator: The Doctor chooses the treatment（TPC）
    Control Group：The Doctor chooses the treatment（TPC）：Eribulin Mesilate injection；Capecitabine Tablets；Gemcitabine Hydrochloride for Injection；Vinorelbine Tartrate Injection；Paclitaxel (albumin-bound). Eribulin Mesilate injection：on days 1 and 8 of the 21-day cycle, 1.4 mg/m2 , intravenous administration; Capecitabine Tablets: On days 1 to 14 of the 21-day cycle, 1000-1250mg/m2，oral administration, twice a day (once in the morning and once in the evening; Total daily dose 2000-2500mg/m2); Gemcitabine Hydrochloride for Injection: On days 1, 8 and 15 of the 28-day cycle, 800-1200mg/m2, intravenous administration; Vinorelbine Tartrate Injection: Every first day of the week, 25mg/m2，intravenous administration; Paclitaxel (albumin-bound): On day 1 of the 21-day cycle, 260mg/m2，intravenous administration for more than 30 minutes. Three weeks constituted one course of treatment.

Primary Outcome Measure

Progression-Free-Survival [ Time Frame: Randomization to measured PD or date of death from any cause（up to 24 months) ]

Central Contacts

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