RecruitingPhase 3NCT06279364

A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer

A Randomized, Open-Label, Multicenter Phase 3 Study of SKB264 Versus Investigator's Choice Chemotherapy as First-Line Treatment in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer


Sponsor

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Enrollment

524 participants

Start Date

Feb 28, 2024

Study Type

INTERVENTIONAL

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial compares a new drug called SKB264 (an antibody-drug combination that targets a protein called TROP2) against standard chemotherapy options for people with triple-negative breast cancer (TNBC) that has spread or cannot be surgically removed. **You may be eligible if...** - You have been diagnosed with triple-negative breast cancer (a type that lacks certain hormone receptors) - Your cancer has either spread from the start or returned at least 6 months after completing treatment aimed at a cure - You have not yet received systemic (whole-body) treatment for metastatic or unresectable disease - Your cancer is PD-L1 negative, OR it is PD-L1 positive but returned after immunotherapy for earlier-stage disease - You are in good physical condition (ECOG 0-1) - You have a life expectancy of at least 3 months - You have adequate organ function **You may NOT be eligible if...** - You have another active cancer - You have significant heart disease - You have a history of severe lung inflammation - You have active hepatitis B, C, or HIV - You have previously received TROP2-targeted therapies or topoisomerase 1 inhibitors - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSKB264

IV Infusion

DRUGPaclitaxel

IV Infusion.

DRUGNab-paclitaxel

IV infusion.

DRUGCapecitabine

Tablet. Oral route of administration.

DRUGEribulin

IV infusion.

DRUGCarboplatin

IV infusion.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06279364