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A Phase III Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer - Trial NCT06081959

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.

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NCT06081959
Phase 3
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov • NCT06081959
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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

Study Focus

Metastatic Breast Cancer

SKB264

Interventional

drug

Sponsor & Location

Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

Timeline & Enrollment

Phase 3

Nov 30, 2023

Dec 31, 2027

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 breast
Malignant neoplasm of breast
Malignant neoplasm: Breast, unspecified
Malignant neoplasm: Central portion of breast
Malignant neoplasm: Overlapping lesion of breast

Data Source

ClinicalTrials.gov

NCT06081959

Non-Device Trial