JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu Alphamab Biopharmaceuticals Co., Ltd

About this trial

This study is a randomized controlled, open-label, multicenter phase III clinical study evaluating the efficacy and safety of chemotherapy selected by investigator JSKN003 s in subjects with recurrent or metastatic breast cancer who have previously failed first- or second-line chemotherapy in subjects with recurrent or metastatic breast cancer who have failed prior first- or second-line chemotherapy.

The study planned to enroll 408 subjects in a 1:1 ratio and stratified block randomization method assigned to:

* Experimental group: JSKN003 monotherapy * Control group: investigator's chosen chemotherapy drug (capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin) monotherapy

Eligibility criteria

Qualifiers

1. The subject is able to understand the informed consent form, voluntarily participate and sign the informed consent form.

Disqualifiers

1. Untreated, or unstable brain parenchymal metastases, spinal cord metastases or compression, cancerous meningitis.

Trial design

Treatments tested in this trial

  • JSKN003
  • Capecitabine tablets
  • Gemcitabine hydrochloride for injection
  • Vinorelbine tartrate injection
  • Paclitaxel for injection (albumin-bound type)
  • Docetaxel injection
  • Eribulin mesylate injection

Treatment groups

400 Participants
are divided into 2 treatment groups