A Randomized, Open-label, Multicenter Phase 3 Study of SKB264 Versus Treatment of Physician's Choice (TPC) in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 376
- 试验地点
- 2
- 主要终点
- Progression-free survival (PFS) assessed by BIRC per RECIST 1.1.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of SKB264 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer.
详细描述
This is a randomized, open-label, multicenter Phase 3 clinical study to evaluate SKB264 monotherapy versus Treatment of Physician's Choice (TPC) in subjects with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer who had failed at least one line of systemic chemotherapy.
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
- •Males or females aged ≥ 18 to ≤ 75 years at the time of signing the ICF;
- •Histologically and/or cytologically confirmed HR+/HER2- breast cancer based on pathology reports on recent biopsy specimens or other pathological samples;
- •Patients who had failed at least one line of systemic chemotherapy in unresectable locally advanced, recurrent, or metastatic stage;
- •Patients with at least one measurable lesion per RECIST 1.1 criteria; those with only skin or bone lesions cannot be included;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
- •Expected survival ≥ 12 weeks;
- •Adequate organ and bone marrow function;
- •Patients who are eligible for a chemotherapy regimen in the control group;
- •Female patients of childbearing potential and male patients with partners of childbearing potential who use effective medical contraception from the time of signing the informed consent form until 6 months after the last dose;
- •Patients who voluntarily participate in the study and sign the ICF, and able to comply with the visit and related procedures stipulated in the plan.
排除标准
- •Patients with a history of central nervous system (CNS) metastases or current CNS metastases；
- •Patients with other malignancies (except cured basal or squamous cell skin cancer or carcinoma in situ of the cervix) within 3 years prior to the first dose;
- •Patients with any cardio cerebral Vascular disease or cardio cerebral vascular risk factors may affect investigational treatment;
- •Uncontrollable systemic diseases assessed by the investigator;
- •History of (noninfectious) interstitial lung disease (ILD)/noninfectious neumonitis requiring steroid therapy and current ILD/noninfectious pneumonitis, or ILD/noninfectious pneumonitis at screening that cannot be excluded by imaging;
- •Clinically serious lung injuries caused by lung diseases;
- •Patients with active chronic Inflammatory bowel disease, gastrointestinal obstruction, severe ulcer, gastrointestinal perforation, abdominal abscess or acute gastrointestinal bleeding;
- •Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1;
- •Active hepatitis B or hepatitis C;
- •Human immunodeficiency virus (HIV) antibody test positive or a history of acquired immunodeficiency syndrome (AIDS), known active syphilis infection;
- •Known allergy or hypersensitivity to SKB264, or the excipients of SKB264;
- •Prior TROP2 targeted therapy, prior topoisomerase I inhibitor therapy, including antibody-drugconjugate(ADC) therapy;
- •Patients who received major surgeries 4 weeks prior to the first dose of study treatment or planned to receive major surgeries during the study ;
- •Patients with concomitant infections requiring systemic antibiotic therapy within 2 week prior to the first dose of study treatment;
- •Patients who have received live vaccines within 30 days prior to the first dose, or are scheduled to receive live vaccines during the study;
- •Pregnant or lactating women.
研究组 & 干预措施
SKB264 for injection
干预措施: SKB264 (Drug)
Treatment of Physician's Choice
Eribulin, capecitabine, gemcitabine or vinorelbine will be administered and managed according to the investigator's clinical judgment, guided by clinical practice.
干预措施: Eribulin (Drug)
Treatment of Physician's Choice
Eribulin, capecitabine, gemcitabine or vinorelbine will be administered and managed according to the investigator's clinical judgment, guided by clinical practice.
干预措施: Capecitabine (Drug)
Treatment of Physician's Choice
Eribulin, capecitabine, gemcitabine or vinorelbine will be administered and managed according to the investigator's clinical judgment, guided by clinical practice.
干预措施: Gemcitabine (Drug)
Treatment of Physician's Choice
Eribulin, capecitabine, gemcitabine or vinorelbine will be administered and managed according to the investigator's clinical judgment, guided by clinical practice.
干预措施: Vinorelbine (Drug)
结局指标
主要结局
Progression-free survival (PFS) assessed by BIRC per RECIST 1.1.
时间窗: up to 24 months
PFS, defined as the time from randomization to PD or death, whichever occurs first.
次要结局
- Duration of Response (DoR)(up to 24 months)
- Progression-free survival (PFS) assessed by the investigators per RECIST V 1.1(up to 24 months)
- Overall Survival (OS)(up to 24 months)
- Objective Response Rate (ORR)(up to 24 months)
- Disease Control Rate (DCR)(up to 24 months)
- Quality of life of patients evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale(Up to 2 years)
- AEs and SAEs(AEs should be observed and recorded from signing the ICF until 30 days after the last dose. AEs occurring 30 days after the last dose are not required to be actively collected by the investigator.)