CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 400 target
Drug / intervention
JSKN003 +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06079983
NCT06079983Phase 3RecruitingMonitorUpdated 9mo ago · Completion was 3mo ago
Slow Enrollment
Monitor

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·interventional·Posted Oct 12, 2023·Updated Sep 12, 2025

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

Enrolling slower than its timeline implies

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesChina
Collaborators--

Timeline

Phase 3Recruiting
202420252026202720282029
First PostedOct 12, 2023
Enrollment StartDec 1, 2023
Primary CompletionApr 1, 2026
Study CompletionMar 1, 2029
TodayJul 1, 2026
Enrollment to primary: 2.3 yearsPosted 2.7 years ago

Interventions

JSKN003drug

Administered intravenously according to protocol.

Capecitabine tabletsdrug

Administered according to protocol, as one option for investigator's choice (determined before randomization).

Gemcitabine hydrochloride for injectiondrug

Administered according to protocol, as one option for investigator's choice (determined before randomization).

Vinorelbine tartrate injectiondrug

Administered according to protocol, as one option for investigator's choice (determined before randomization).

Paclitaxel for injection (albumin-bound type)drug

Administered according to protocol, as one option for investigator's choice (determined before randomization).

Docetaxel injectiondrug

Administered according to protocol, as one option for investigator's choice (determined before randomization).

Eribulin mesylate injectiondrug

Administered according to protocol, as one option for investigator's choice (determined before randomization).