NCT07657130招募中2 期
A Prospective, Randomized Controlled Phase II Trial Investigating the Optimal Timing of Antibody Drug Conjugates in Advanced HER2-Negative Breast Cancer Patients
Liaoning Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年7月1日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
研究概览
简要总结
This study plans to initiate a prospective, randomized controlled trial to investigate the optimal timing of antibody drug conjugate (ADC) therapy in the management of advanced Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer.
Primary Objective:
To compare the difference in PFS2 (Time from randomization to disease progression after second therapy) between antibody-drug conjugate (ADC) followed by chemotherapy versus chemotherapy followed by ADC in the treatment of advanced HER2-negative breast cancer.
Secondary Objectives:
To compare overall survival (OS), adverse events, patient-reported outcomes, and cost-effectiveness between the two treatment sequences. Additionally, to identify potential biomarkers predictive of benefit from frontline ADC therapy.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18-75 years;
- •Histologically confirmed advanced HER2-negative breast cancer, including IHC 2+/ISH-, IHC 1+/ISH-, and IHC 0/ISH- subtypes;
- •Completed first-line combination chemotherapy for advanced/metastatic disease (specific regimen not restricted), with disease progression (PD) evaluated per RECIST criteria (HR-positive patients must have received at least one line of endocrine therapy);
- •Electrocorticography (ECOG) performance status < 2;
- •Estimated life expectancy ≥ 12 weeks;
- •Adequate bone marrow function, defined as:
- •ANC ≥ 1.5 × 10⁹/L
- •Platelets ≥ 90 × 10⁹/L
- •Hemoglobin ≥ 90 g/L
- •Adequate hepatic and renal function, defined as:
- •Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
- •AST or ALT ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases)
- •Creatinine clearance ≥ 60 mL/min
- •Signed informed consent obtained prior to any study-related procedures or treatments, confirming the patient's willingness to participate and comply with study requirements.
排除标准
- •Prior treatment with an ADC after disease recurrence or metastasis;
- •Pregnant or breastfeeding women;
- •No evaluable recurrent or metastatic lesions as defined by RECIST 1.1 criteria;
- •Symptomatic brain parenchymal and/or leptomeningeal metastases with symptoms not adequately controlled by treatment;
- •History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix, cutaneous squamous cell carcinoma, or well-controlled localized basal cell carcinoma of the skin;
- •Psychiatric disorders or other conditions that may interfere with patient compliance;
- •Recent history of serious and uncontrolled systemic diseases, such as clinically significant cardiovascular disease, pulmonary disease, metabolic disorders, or arterial/venous thromboembolic events;
- •Concurrent use of other investigational drugs, or participation in another clinical trial within 30 days prior to enrollment;
- •Known or suspected allergy to any study drug or its excipients;
- •Any other condition that, in the opinion of the investigator, renders the patient unsuitable for participation in this trial.
研究者
Tao Sun
Principal Investigator
Liaoning Cancer Hospital & Institute
研究点 (1)
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