Comparing SKB264 to standard chemotherapy for advanced 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

This study is testing a new treatment called SKB264 to see if it works better than standard chemotherapy for patients with advanced triple-negative breast cancer that can't be surgically removed.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 524 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06279364 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial aims to evaluate the efficacy and safety of SKB264 as a first-line treatment for patients with unresectable recurrent or metastatic triple-negative breast cancer (TNBC). The study is randomized and open-label, comparing SKB264 to investigator's choice of chemotherapy in patients whose tumors do not express PD-L1 or who have previously received anti-PD-1/PD-L1 inhibitors. Participants will be monitored for treatment outcomes and safety profiles over the course of the trial.

Who should consider this trial

Good fit: Ideal candidates include patients with confirmed TNBC who have not received prior systemic therapy for their advanced disease and meet specific eligibility criteria.

Not a fit: Patients with active second malignancies or those who have uncontrolled significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced triple-negative breast cancer.

How similar studies have performed: Other studies have shown promise with similar approaches, but the specific efficacy of SKB264 in this context is still being evaluated.

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 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.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Xiaoping Jin, PhD

Conditions Triple Negative Breast Cancer