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A Study of SKB264 Versus Investigator's Choice of Chemotherapy in Subjects With Unresectable Locally Advanced, Relapsed, or Metastatic HR+/HER2- Breast Cancer Who Have Previously Failed Endocrine Therapy

NCT07071337 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 430

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 who have previously failed endocrine therapy.

Conditions

Interventions

DRUG

SKB264

5mg/kg, IV on Day 1 and Day 15 of each 28 day cycle

DRUG

Nab-paclitaxel

100 mg/m\^2, IV, on Days 1, 8, and 15 every 4 weeks

DRUG

Paclitaxel

90 mg/m\^2, IV, on Days 1, 8, and 15 every 4 weeks; or 80 mg/m\^2, IV, weekly, every 3 weeks

DRUG

Capecitabine

1000-1250 mg/m\^2, orally, Days 1-14, twice daily, every 3 weeks

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
2025-07-18
Primary Completion
2027-07-31
Completion
2031-02-28

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 NCT07071337 on ClinicalTrials.gov