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

Recruiting Phase 3 Interventional Study
Triple Negative Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
524 (estimated)
Sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Industry
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About This Trial

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

Trial Locations
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Eligibility Criteria
Key Inclusion Criteria: 1. Histologically and/or cytologically confirmed TNBC. 2. De novo metastatic or relapsed ≥ 6 months post completion of treatment with curative intent. 3. No prior systemic anti-cancer therapy for unresectable recurrent or metastatic disease. 4. Participants whose tumours are…
Contacts

Xiaoping Jin, PhD

86-028-67255165

jinxp@kelun.com

CONTACT