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JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer

ConditionUnrespectable Locally Advanced and or Metastatic HER2 Positive Breast Cancer Participants
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • JSKN003

    Drug

    Administered intravenously according to protocol.

  • Trastuzumab emtansine (T-DM1)

    Drug

    Administered intravenously according to the approved label.

Treatment groups

228 Participants
are divided into 2 treatment groups
Group A: JSKN003Experimental treatment 1 intervention
Group B: T-DM1Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS) by BIRC

Time frame
Up to approximately 4 years

Secondary outcomes

1

Progression-free survival (PFS) by investigator

Time frame
Up to approximately 4 years
2

Overall Survival (OS)

Time frame
Up to approximately 4 years
3

Objective Response Rate (ORR)

Time frame
Up to approximately 4 years
4

Disease Control Rate (DCR)

Time frame
Up to approximately 4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai JMT-Bio Inc.

Lead sponsor

Source ClinicalTrials.gov
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