A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
SKB264: IV Infusion
Paclitaxel: IV Infusion.
Nab-paclitaxel: IV infusion.
Capecitabine: Tablet. Oral route of administration.
Eribulin: IV infusion.
Carboplatin: IV infusion.
Study summary
The aim of the study is to evaluate the efficacy and safety of SKB264 as first-line treatment for patients with unresectable recurrent or metastatic triple-negative breast cancer (TNBC) whose tumors do not express programmed cell death ligand 1 (PD-L1) or in patients with PD-L1 positive tumors who received prior anti-programmed cell death 1 (PD-1)/PD-L1 inhibitor in early setting
Eligibility
Primary outcome measure(s)
- Overall Survival (OS) — Randomization up to approximately 40 months
OS is defined as the time from randomization until the date of death due to any cause. - Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) — Randomization up to approximately 28 months
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality |
More Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06279364 on ClinicalTrials.gov ↗ ← All trials in China