Pure Global AI
NCT06081959Not yet recruiting

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

A Randomized, Open-label, Multicenter Phase 3 Study of SKB264 Versus Treatment of Physician's Choice (TPC) in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.Phase 3ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Metastatic Breast Cancer
Drug/Device/Intervention
SKB264
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Timeline & enrollment
Phase
Phase 3
Start date
Nov 30, 2023
End date
Dec 31, 2027
Enrollment
376 participants
Primary outcome

Progression-free survival (PFS) assessed by BIRC per RECIST 1.1.

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.

ICD-10 classifications
Malignant neoplasm of breastMalignant neoplasm of breastMalignant neoplasm: Breast, unspecifiedMalignant neoplasm: Central portion of breastMalignant neoplasm: Overlapping lesion of breast
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06081959
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06081959 through Pure Global AI's free database. This Phase 3 trial is sponsored by Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. and is currently Not yet recruiting. The study focuses on Metastatic Breast Cancer. Target enrollment is 376 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.