Triple Negative Breast Cancer
Conditions
Brief 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
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
DRUGSKB264
IV Infusion
DRUGPaclitaxel
IV Infusion.
DRUGNab-paclitaxel
IV infusion.
DRUGCapecitabine
Tablet. Oral route of administration.
DRUGEribulin
IV infusion.
DRUGCarboplatin
IV infusion.
Sponsors
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomised in a 1:1 ratio to one of two intervention groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Randomization up to approximately 28 months | ORR is defined as the percentage of patients who achieve complete response(CR) or partial response (PR), as assessed by BICR/investigator per RECIST 1.1 |
| Duration of Response (DoR) | Randomization up to approximately 28 months | DoR is defined as the time from the date of first documented CR or PR until date of documented disease progression per RECIST 1.1, as assessed by BICR/investigator or death due to any cause, whichever occurs first. |
| Progression-Free Survival (PFS) assessed by Investigator | 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 investigator or death due to any cause, whichever occurs first. |
| Disease control rate (DCR) | Randomization up to approximately 28 months | DCR is defined as the percentage of patients who achieve CR, PR or stable disease (SD), as assessed by BICR/investigator per RECIST 1.1 |
| Time to Response (TTR) | Randomization up to approximately 28 months | TTR is defined as the time from the date of randomization until the first documentation of CR or PR as assessed by BICR/investigator per RECIST 1.1. |
| Adverse events(AEs) and severe adverse events (SAEs) | AEs should be collected from signing the informed consent form (ICF) until 30 days after the last dose | Incidence and severity of AEs and SAEs, and clinically significant lab abnormalities |
Countries
China
Contacts
CONTACTXiaoping Jin, PhD
Outcome results
None listed