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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 524
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
排除标准
- •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.
研究组 & 干预措施
SKB264
Participants will receive SKB264 on Day 1 and Day 15 of each 4-week cycle
干预措施: SKB264 (Drug)
Investigator's choice chemotherapy
If no prior taxane, or prior taxane in the (neo)adjuvant setting and disease-free interval (DFI) >12 months: paclitaxel or nab-paclitaxel.
If prior taxane and DFI ≤ 12 months: capecitabine, eribulin. If known BRCA1/2 mutation: carboplatin
干预措施: Nab-paclitaxel (Drug)
Investigator's choice chemotherapy
If no prior taxane, or prior taxane in the (neo)adjuvant setting and disease-free interval (DFI) >12 months: paclitaxel or nab-paclitaxel.
If prior taxane and DFI ≤ 12 months: capecitabine, eribulin. If known BRCA1/2 mutation: carboplatin
干预措施: Paclitaxel (Drug)
Investigator's choice chemotherapy
If no prior taxane, or prior taxane in the (neo)adjuvant setting and disease-free interval (DFI) >12 months: paclitaxel or nab-paclitaxel.
If prior taxane and DFI ≤ 12 months: capecitabine, eribulin. If known BRCA1/2 mutation: carboplatin
干预措施: Capecitabine (Drug)
Investigator's choice chemotherapy
If no prior taxane, or prior taxane in the (neo)adjuvant setting and disease-free interval (DFI) >12 months: paclitaxel or nab-paclitaxel.
If prior taxane and DFI ≤ 12 months: capecitabine, eribulin. If known BRCA1/2 mutation: carboplatin
干预措施: Eribulin (Drug)
Investigator's choice chemotherapy
If no prior taxane, or prior taxane in the (neo)adjuvant setting and disease-free interval (DFI) >12 months: paclitaxel or nab-paclitaxel.
If prior taxane and DFI ≤ 12 months: capecitabine, eribulin. If known BRCA1/2 mutation: carboplatin
干预措施: Carboplatin (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: 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)
时间窗: 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.
次要结局
- Objective Response Rate (ORR)(Randomization up to approximately 28 months)
- Duration of Response (DoR)(Randomization up to approximately 28 months)
- Progression-Free Survival (PFS) assessed by Investigator(Randomization up to approximately 28 months)
- Disease control rate (DCR)(Randomization up to approximately 28 months)
- Time to Response (TTR)(Randomization up to approximately 28 months)
- 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)