Actively Recruiting
A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer
Led by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Updated on 2026-05-08
524
Participants Needed
1
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed triple-negative breast cancer
- De novo metastatic or relapsed at least 6 months after completing curative treatment
- No prior systemic anti-cancer treatment for unresectable recurrent or metastatic disease
- Tumors that are PD-L1 negative or PD-L1 positive with relapse after prior anti-PD-1/PD-L1 inhibitor in early-stage disease
- At least one measurable lesion according to RECIST v1.1
- ECOG performance status of 0 to 1 without worsening within 2 weeks before randomization
- Life expectancy of at least 3 months
- Eligible for investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, eribulin, or carboplatin)
- Adequate organ and bone marrow function
You will not qualify if you...
- Active second malignancy
- Uncontrolled or clinically significant cardiovascular disease
- History of noninfectious pneumonitis or interstitial lung disease requiring steroids or current pneumonitis/ILD
- Active infection needing systemic treatment within 2 weeks of randomization
- Active hepatitis B or C virus infection
- HIV positive or history of AIDS; known active syphilis infection
- Known allergy to SKB264 or its ingredients
- Previous treatment with TROP2-targeted therapy or topoisomerase 1 inhibitors
- Prior treatment with the same investigator's choice chemotherapy except taxane
- Pregnant or breastfeeding women
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
X
Xiaoping Jin, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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