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Recruiting NCT06279364

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

Phase III Interventional Triple Negative Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SKB264, Paclitaxel, Nab-paclitaxel, Capecitabine.
Who it may be relevant to
Registry conditions: Triple Negative Breast Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

This is a randomized, open-label, multicenter, Phase 3 study to evaluate the efficacy and safety of SKB264 versus investigator's choice chemotherapy as first-line treatment for patients with unresectable recurrent or metastatic TNBC whose tumors do not express PD-L1 or in patients with PD-L1 positive tumors who received prior anti-PD-1/PD-L1 inhibitor in early setting.

Interventions

  • Drug SKB264
    IV Infusion
  • Drug Paclitaxel
    IV Infusion.
  • Drug Nab-paclitaxel
    IV infusion.
  • Drug Capecitabine
    Tablet. Oral route of administration.
  • Drug Eribulin
    IV infusion.
  • Drug Carboplatin
    IV infusion.

Primary outcome measures

  • Overall Survival (OS) [Time frame: Randomization up to approximately 40 months]
  • Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) [Time frame: Randomization up to approximately 28 months]
Secondary outcome measures (6)
  • Objective Response Rate (ORR) [Time frame: Randomization up to approximately 28 months]
  • Duration of Response (DoR) [Time frame: Randomization up to approximately 28 months]
  • Progression-Free Survival (PFS) assessed by Investigator [Time frame: Randomization up to approximately 28 months]
  • Disease control rate (DCR) [Time frame: Randomization up to approximately 28 months]
  • Time to Response (TTR) [Time frame: Randomization up to approximately 28 months]
  • Adverse events(AEs) and severe adverse events (SAEs) [Time frame: AEs should be collected from signing the informed consent form (ICF) until 30 days after the last dose]

Eligibility criteria

Inclusion criteria

  • Histologically and/or cytologically confirmed TNBC.
  • De novo metastatic or relapsed ≥ 6 months post completion of treatment with curative intent.
  • No prior systemic anti-cancer therapy for unresectable recurrent or metastatic disease.
  • 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.
  • At least one measurable lesion per RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 2 weeks prior to randomization.
  • A life expectancy of at least 3 months.
  • Eligible for the chemotherapy options listed as investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, eribulin, or carboplatin) as assessed by the investigator.
  • Adequate organ and bone marrow function.

Exclusion criteria

  • Active second malignancy.
  • Uncontrolled or clinical significant cardiovascular disease.
  • History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
  • Active infection requiring systemic therapy within 2 weeks of randomization.
  • Active hepatitis B or hepatitis C virus infection.
  • Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
  • Known hypersensitivity to SKB264 or its excipients.
  • Previously received TROP2-targeted therapy or topoisomerase 1 inhibitors.
  • Prior treatment with the same investigator's choice chemotherapy (except taxane).
  • Pregnant or lactating women.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fudan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT06279364 · SKB264-Ⅲ-11

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗