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SKB264 Injection vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer

NCT05347134 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2026-05-08

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy of SKB264 in patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer who have failed second-line or above prior standard of care

Conditions

Interventions

DRUG

SKB264

SKB264 ：5 mg/kg, IV (in the vein) on day 1 and Day 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops. Eribulin:1.4mg/m2, IV (in the vein) on day 1 and Day 8 of each 281day cycle. Number of Cycles: until progression or unacceptable toxicity develops. Capecitabine:1000-1250mg/m2, po,bid, from day 1 to Day 15 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops. Gemcitabine:800-1000 mg/m2, IV (in the vein) on day 1 and Day 8 of each 281day cycle. Number of Cycles: until progression or unacceptable toxicity develops. Vinorelbine:25 mg/m2, IV (in the vein) on day 1 and Day 8 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.

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
2022-06-10
Primary Completion
2023-11-30
Completion
2027-06-30

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 NCT05347134 on ClinicalTrials.gov