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

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),

Trial Details

NCT ID
NCT06143553
Phase
PHASE3
Sponsor
Shanghai Yizhong Pharmaceutical Co., Ltd.
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Paclitaxel Polymeric Micelles for Injection
  • Eribulin Mesilate injection
  • Capecitabine Tablets
  • Gemcitabine Hydrochloride for Injection
  • Vinorelbine Tartrate Injection
  • Paclitaxel (albumin-bound)
Locations (sample)
  • Nanjing, Jiangsu, China|32.06167,118.77778
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

  • Eligible subjects must meet all the following criteria:
  • Male or female 18 years and older;
  • Understand the purpose, benefits and risks of this clinical trial, voluntarily participate in and sign the written informed consent;
  • The Eastern Cooperative Oncology Group (ECOG)performance status is 0 or 1;

For full eligibility, visit ClinicalTrials.gov.

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