JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
A 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
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
400 participants
Dec 1, 2023
INTERVENTIONAL
Conditions
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
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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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).
Locations(87)
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NCT06079983