NCT06079983|RecruitingPhase 3

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 ClinicalTrials.gov

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1 other identifier

JSKN003-302

Study Type

interventional

Target

400

Locations

1 country

Sites

Timeline

RegisteredOct 2023

StartedDec 2023

CompletionMar 2029

Brief 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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

400

participants targeted

Target at P50-P75 for phase_3 breast-cancer

Timeline

34mo left

Started Dec 2023

Geographic Reach

1 country

87 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.3 years study duration

Study Progress46%

Dec 2023Mar 2029

First Submitted

Initial submission to the registry

September 22, 2023

Completed

20 days until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed

2 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed

2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Expected

Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

2.3 years

First QC Date

September 22, 2023

Last Update Submit

September 8, 2025

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

Progression Free Survival (PFS)
PFS evaluated by BICR according to RECIST v1.1 criteria is defined as the time from randomization to the first recorded disease progression or death from any cause as a result of BICR evaluation according to RECIST v1.1 criteria.
up to approximately 3 years after the first enrollment

Secondary Outcomes (3)

Overall survival（OS）
up to approximately 3 years after the first enrollment
Objective Response Rate (ORR)
up to approximately 3 years after the first enrollment
Duration of Response (DOR)
up to approximately 3 years after the first enrollment

Study Arms (2)

JSKN003

EXPERIMENTAL

Administered intravenously according to protocol.

Drug: JSKN003

The chemotherapy chosen by the investigator

ACTIVE COMPARATOR

The mono-chemotherapy drugs selected by the investigators included capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin. The option should be determined before randomization.

Drug: Capecitabine tabletsDrug: Gemcitabine hydrochloride for injectionDrug: Vinorelbine tartrate injectionDrug: Paclitaxel for injection (albumin-bound type)Drug: Docetaxel injectionDrug: Eribulin mesylate injection

Interventions

JSKN003DRUG

Administered intravenously according to protocol.

JSKN003

Capecitabine tabletsDRUG

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