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Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer

NCT06081959 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 376

Last updated 2026-05-08

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of SKB264 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer.

Conditions

Interventions

DRUG

SKB264

IV infusion on day 1 and Day 15 of each 28 day cycle

DRUG

Eribulin

1.4 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle

DRUG

Capecitabine

1000-1250 mg/m2, po, bid, from day 1 to Day 15 of each 21 day cycle

DRUG

Gemcitabine

1000 mg/m2, IV infusion on day 1 and Day 8 of each 21day cycle

DRUG

Vinorelbine

25 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle

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
2023-10-31
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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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 NCT06081959 on ClinicalTrials.gov