At a glance
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NCT06079983Phase 3RecruitingMonitorUpdated 9mo ago · Completion was 3mo agoA Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Trial Of JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
In Brief
A Phase 3 clinical trial evaluating JSKN003, Capecitabine tablets, and 5 other interventions for Breast Cancer. Currently recruiting, targeting 400 participants across 87 sites.
Signals
Detailed Summary
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
Study Details
Timeline
Interventions
Administered intravenously according to protocol.
Administered according to protocol, as one option for investigator's choice (determined before randomization).
Administered according to protocol, as one option for investigator's choice (determined before randomization).
Administered according to protocol, as one option for investigator's choice (determined before randomization).
Administered according to protocol, as one option for investigator's choice (determined before randomization).
Administered according to protocol, as one option for investigator's choice (determined before randomization).
Administered according to protocol, as one option for investigator's choice (determined before randomization).