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A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer

NCT06279364 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 524

Last updated 2026-05-08

No results posted yet for this study

Summary

The aim of the study is to evaluate the efficacy and safety of SKB264 as first-line treatment for patients with unresectable recurrent or metastatic triple-negative breast cancer (TNBC) whose tumors do not express programmed cell death ligand 1 (PD-L1) or in patients with PD-L1 positive tumors who received prior anti-programmed cell death 1 (PD-1)/PD-L1 inhibitor in early setting

Conditions

Interventions

DRUG

SKB264

IV Infusion

DRUG

Paclitaxel

IV Infusion.

DRUG

Nab-paclitaxel

IV infusion.

DRUG

Capecitabine

Tablet. Oral route of administration.

DRUG

Eribulin

IV infusion.

DRUG

Carboplatin

IV infusion.

Sponsors & Collaborators

  • Sichuan Kelun-Biotech Biopharmaceutical 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
2024-02-28
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
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 NCT06279364 on ClinicalTrials.gov