A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurre… (NCT06279364) | Clinical Trial Compass
RecruitingPhase 3
A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer
China524 participantsStarted 2024-02-28
Plain-language 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
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. 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.
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.
What they're measuring
1
Overall Survival (OS)
Timeframe: Randomization up to approximately 40 months
2
Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)
Timeframe: Randomization up to approximately 28 months