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Active, not recruiting Phase 3

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

NCT06279364 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2024-02-28
Last updated
2026-10-21

Condition(s) studied

Triple Negative Breast Cancer

Investigational drug(s) / intervention(s)

SKB264 →Paclitaxel →Nab-paclitaxel →Capecitabine →Eribulin →Carboplatin →

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 PD-L1-negative, or participants whose tumors are PD-L1 positive and have relapsed after prior anti-PD-1/PD-L1 inhibitor for early-stage disease. 5. At least one measurable lesion per RECIST v1.1. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 2 weeks prior to randomization. 7. A life expectancy of at least 3 months. 8. Eligible for the chemotherapy options listed as investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, eribulin, or carboplatin) as assessed by the investigator. 9. Adequate organ and bone marrow function. Key Exclusion Criteria: 1. Active second malignancy. 2. Uncontrolled or clinical significant cardiovascular disease. 3. History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD. 4. Active infection requiring systemic therapy within 2 weeks of randomization. 5. Active hepatitis B or hepatitis C virus infection. 6. Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection. 7. Known hypersensitivity to SKB264 or its excipients. 8. Previously received TROP2-targeted therapy or topoisomerase 1 inhibitors. 9. Prior treatment with the same investigator's choice chemotherapy (except taxane). 10. Pregnant or lactating women.

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)

FacilityCityRegionStatus
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality
Official registry record

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