Study on ctDNA-guided Treatment Decision-making for HER2-negative Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS) in TNBC (Group A vs Group B)
研究概览
简要总结
This is an exploratory, ctDNA-guided, multi-stage clinical study designed to evaluate the clinical value of treatment decision-making based on circulating tumor DNA (ctDNA) variant allele frequency (VAF) dynamics in patients with HER2-negative metastatic breast cancer.
All enrolled patients will receive antibody-drug conjugate (ADC) therapy for two cycles in Stage 1, with serial ctDNA assessments performed prior to Cycle 1 and Cycle 2. In Stage 2, patients without disease progression will be assigned to different treatment strategies based on the percentage reduction in mean ctDNA VAF.
The study aims to assess whether ctDNA VAF dynamics can serve as an early biomarker to guide treatment intensification and improve clinical outcomes in metastatic breast cancer.
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
- •Age 18-75 years；ECOG performance status 0-1； Histologically or cytologically confirmed HER2-negative metastatic breast cancer； At least one measurable lesion per RECIST v1.1； Eligible for ADC therapy； Adequate organ and bone marrow function； Life expectancy ≥3 months； Willingness to provide tumor tissue and blood samples； Signed informed consent
排除标准
- •Prior treatment with ADC targeting the same antigen and payload；History of grade ≥3 immune-related adverse events； Active or untreated CNS metastases； Active autoimmune disease requiring systemic therapy； Clinically significant cardiovascular disease； Active interstitial lung disease； Active infection including tuberculosis, HIV, hepatitis B or C； Pregnancy or breastfeeding；Investigator-determined conditions that may interfere with study participation
研究组 & 干预措施
ADC + Ivonescimab
Patients with <50% mean ctDNA VAF reduction receive ADC combined with ivonescimab.
干预措施: ADC (Drug)
ADC + Ivonescimab
Patients with <50% mean ctDNA VAF reduction receive ADC combined with ivonescimab.
干预措施: Ivonescimab (Drug)
ADC Monotherapy
Patients with <50% mean ctDNA VAF reduction receive continued ADC monotherapy.
干预措施: ADC (Drug)
ADC Monotherapy (ctDNA responder cohort)
Patients with ≥50% mean ctDNA VAF reduction continue ADC monotherapy.
干预措施: ADC (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) in TNBC (Group A vs Group B)
时间窗: From randomization until progression or death (up to 36 months)
Time from randomization to disease progression or death, assessed by RECIST v1.1.
次要结局
- ORR (RECIST v1.1)，DoR，CBR，OS，Safety (CTCAE v5.0)(From treatment initiation until end of follow-up)
研究者
Hongxia Wang
Prof. Hongxia Wang
Fudan University