NCT06383767招募中3 期
A Open-label, Randomized, Multicenter Phase III Study of ESG401 Versus Investigator's Choice Chemotherapy in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 378
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS) assessed by IRC per RECIST 1.1
研究概览
简要总结
The aim of this study is to evaluate the efficacy and safety of ESG401 in patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer.
详细描述
This is a open-label, randomized, multicenter Phase 3 study to evaluate ESG401 versus Treatment of Physician's Choice (TPC) in subjects with unresectable locally advanced 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals able to understand and give written informed consent.
- •Males or females aged ≥ 18 years ;
- •Histologically and/or cytologically confirmed HR+/HER2- breast cancer who had failed at least one line of systemic chemotherapy in metastatic settings;
- •Patients who are eligible for a chemotherapy regimen in the control group;
- •Patients with at least one measurable lesion per RECIST 1.1 criteria;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
- •Expected survival ≥ 12 weeks;
- •Patients with adequate organ and bone marrow function;
- •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 180 days after the last dose.
排除标准
- •Received chemotherapy, targeted therapy, immunotherapy, interventional therapy or other systemic anti-cancer therapie within 4 weeks before the first investigational product administration;
- •Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1;
- •Received major surgeries 4 weeks prior to the first dose of study treatment or planned to receive major surgeries during the study ;
- •Prior topoisomerase I inhibitor therapy, including antibody-drugconjugate(ADC) therapy, or prior TROP2 targeted therapy, or use of any investigational anti-cancer drug within 28 days or 5 half-lives before the first investigational product administration;
- •New thromboembolic events, intestinal obstruction, gastrointestinal bleeding or perforation within 6 months;
- •Uncontrolled systemic bacterial, viral or fungal infections;
- •Subjects with symptomatic or untreated CNS metastases, or those requiring ongoing treatment for CNS metastases;
- •Patients with Primary CNS malignancy；or patients with other malignancies within 3 years prior to the first dose;
- •Patients with uncontrollable systemic diseases;
- •Patients with gastrointestinal diseases (such as chronic gastritis, chronic enteritis or gastric ulcers), or with a previous history of severe or chronic diarrhea;
- •Subjects with clinically significant cardiovascular disease;
- •Human Immunodeficiency Virus (HIV) infection;
- •Active hepatitis B or hepatitis C;
- •Known immediate or delayed hypersensitivity reaction to irinotecan or other camptocampin derivatives such as topotecan or to have had grade ≥3 gastrointestinal reactions associated with irinotecan, or allergies, or to any investigational drug or excipient ingredient;
- •Pregnant or lactating women.
研究组 & 干预措施
ESG401 for injection
Experimental
IV infusion on day 1, 8 and15 of each 28 day cycle
干预措施: ESG401 (Drug)
Treatment of Physician's Choice
Active Comparator
Eribulin 1.4 mg/m2, IV infusion on day 1 and 8 of each 21 day cycle
Capecitabine 1000 or 1250 mg/m2, po, from day 1 to 14 of each 21 day cycle
Vinorelbine 25 mg/m2, IV infusion on day 1 and 8 of each 21 day cycle
Gemcitabine 1000 mg/m2, IV infusion on day 1,8 and 15 of each 28day cycle
干预措施: Eribulin, capecitabine, gemcitabine or vinorelbine (Treatment of Physician's Choice) (Drug)
结局指标
主要结局
Progression-free survival (PFS) assessed by IRC per RECIST 1.1
时间窗: Up to 24 months
PFS was defined as the time from randomization to PD or death, whichever occurs first.
次要结局
- Objective Response Rate (ORR)(Up to 24 months)
- Adverse events(AEs) and severe adverse events (SAEs)(From signing the ICF up to last dose plus 30 days)
- Progression-free survival (PFS) assessed by the investigators per RECIST V 1.1(Up to 24 months)
- Clinical Benefit Rate (CBR)(Up to 24 months)
- Clearance(Up to 24 months)
- Overall Survival (OS)(Up to 24 months)
- Duration of Response (DoR)(Up to 24 months)
- Volume of distribution(Up to 24 months)
- ADA(Up to 24 months)
- Quality of life evaluated using the NCC-BC-A scale(Up to 24 months)
研究者
研究点 (1)
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