JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai JMT-Bio Inc.
About this trial
This study is designed to compare the safety and efficacy of JSKN003 versus T-DM1 in unrespectable locally advanced and/or metastatic HER2-positive breast cancer participants previously treated with trastuzumab and taxane.
Eligibility criteria
Qualifiers
1. Voluntarily agree to participate in the study and sign the informed consent.
2.Age≥18 years old.
3.Patients with unresectable locally advanced or metastatic breast cancer confirmed by histology or cytology.
4.Confirmed to be HER2 positive (HER2-positive is defined as IHC 3+ or IHC 2+ with ISH positive) by the pathology department of participating study center.
Disqualifiers
1. Have previously been treated with an anti-HER2 ADC loaded with topoisomerase I inhibitors or medenosin derivative 1 (DM1) or have relapsed after receiving such therapy during or within 12 months after the adjuvant/neo-adjuvant setting or in the advanced stage.
2.History of any other malignant tumors within three years before randomization.
3.With uncontrollable serous effusion within 14 days before randomization, which requires frequent drainage or medical intervention.
4.Known contraindication to T-DM1or not suitable to receive JSKN003 or T-DM1 by investigator.
Trial design
Treatments tested in this trial
- JSKN003
- Trastuzumab emtansine (T-DM1)
Treatment groups
228 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov