MedTrace Logo

A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who Have Failed Standard of Care

NCT07533123 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 364

Last updated 2026-04-16

No results posted yet for this study

Summary

Primary Endpoint of this Study:

To compare Progression-Free Survival (PFS) (as assessed by a Blinded Independent Review Committee \[BIRC\] based on Response Evaluation Criteria in Solid Tumors \[RECIST v1.1\]) between JSKN016 and Treatment of Physician's Choice (TPC) in participants with unresectable locally advanced, recurrent, or metastatic triple-negative breast cancer (TNBC).

To compare Overall Survival (OS) between JSKN016 and TPC in the treatment of unresectable locally advanced, recurrent, or metastatic TNBC.

Conditions

Interventions

DRUG

JSKN016 Injection

Injection; 100 mg (4.0 mL)/vial. Dosage: 6 mg/kg administered via intravenous infusion on Day 1 of each 21-day cycle

DRUG

Eribulin Mcsilate Injection

Injection; 2 mL:1 mg (0.5 mg/mL). Dosage: 1.4 mg/m² administered via intravenous bolus on Day 1 and Day 8 of each 21-day cycle

DRUG

Vinorelbine Tartrate Injection

Injection; 1 mL:10 mg (10 mg/mL). Dosage: 25 mg/m² administered via intravenous infusion on Day 1 and Day 8 of each 21-day cycle

DRUG

Capecitabine Tablets

Tablet; 0.15 g and 0.5 g. Dosage: 1000-1250 mg/m² orally once daily on Days 1-14 of each 21-day cycle (14 days on/7 days off)

DRUG

Gemcitabine Hydrochloride for Injection

Injection; 0.2 g. Dosage: 1000 mg/m² administered via intravenous infusion on Day 1 and Day 8 of each 21-day cycle

DRUG

Sacituzumab Govitecan for Injection

Injection; 180 mg/vial. Dosage: 10 mg/kg administered via intravenous infusion on Day 1 and Day 8 of each 21-day cycle

Sponsors & Collaborators

  • Jiangsu Alphamab Biopharmaceuticals Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-17
Primary Completion
2029-03-17
Completion
2030-03-17

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07533123 on ClinicalTrials.gov