NCT04927481终止2 期
A Multicenter, Open-label, Single-arm, Phase II Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Advanced HER2 Negative Breast Cancer
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.29 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2021年6月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 28
- 试验地点
- 29
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is a multicenter, open-label, single-arm, phase II study to evaluate the safety and efficacy of Mitoxantrone Hydrochloride Liposome in patients with advanced HER2 negative breast cancer.
详细描述
This is a multicenter, open-label, single-arm, phase II study to evaluate the safety and efficacy of Mitoxantrone Hydrochloride Liposome in patients with advanced HER2 negative breast cancer. Eligible patients will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2 by an intravenous infusion (IV), every 21 days (q3w, 1 cycle) until disease progression, intolerable toxicity, death, or investigator or patient decision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Voluntarily participate in this study and sign informed consent form;
- •Male or female patients aged 18 to 75 years (inclusive);
- •Histologically confirmed diagnosis of HER-2 negative breast cancer (Including immunohistochemistry HER2 0 or 1+, immunohistochemistry HER2 2+ must be confirmed as negative by in situ hybridization);
- •Patients with unresectable locally advanced or recurrent breast cancer with disease progression after first-line or higher chemotherapy；
- •Hormone receptor (HR) negative breast cancer or HR-positive breast cancer that is not suitable for endocrine treatment or is resistant to endocrine treatment.
- •Prior treatment with both an anthracycline (i.e., doxorubicin or epirubicin) and a taxane (i.e., paclitaxel or docetaxel) at least (acceptable for patients not previously treated with anthracyclines due to high risk factors for cardiotoxicity), and four prior chemotherapy regimens at most；
- •At least one measurable lesion according to RECIST v1.1;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
- •Patients must meet the following criteria prior to treatment (not receiving blood transfusion or growth factors therapy within 14 days before the first administration):
- •Absolute neutrophil count (ANC) ≥ 1.5 × 109/L;
- •Hemoglobin ≥ 90g / L;
- •Platelet count ≥ 90 × 109/L;
- •Creatinine ≤1.5 × upper limit of normal (ULN);
- •Total bilirubin ≤ 1.5×ULN;
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 ×ULN (≤ 5 ×ULN for liver metastasis);
- •For women of childbearing potential: the serum pregnancy test must be negative, and patients are willing to take adequate contraceptive measures during the treatment period and for at least 6 months after the last dose of the study drug;
- •Good compliance and willingness to cooperate with follow-up visits.
排除标准
- •Patients who have severe allergic reactions to mitoxantrone hydrochloride or liposome preparation ingredients;
- •History of other malignancy within 3 years, except for radical cure of carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin;
- •Brain metastases and meningeal metastasis;
- •Patients with active hepatitis B (HBsAg positive with hepatitis B virus DNA ≥ 2000 IU/mL), active hepatitis C (hepatitis C virus antibody positive with hepatitis C virus RNA above the lower limit of detection of the study center), or human immunodeficiency virus (HIV) antibody positive;
- •Life expectancy < 3 months;
- •Previous treatment with the anthracyclines, with the total cumulative dose (doxorubicin equivalent) >350 mg/m2;
- •Adverse events from the previous treatment have not resolved to ≤ Grade 1 based on CTCAE (except for the toxicity without safety risk judged by the investigator, such as alopecia, hyperpigmentation);
- •Impaired cardiac function or serious cardiac disease:
- •Long corrected QT interval syndrome or corrected QT interval > 480 ms;
- •Complete left bundle branch block, II-III degree atrioventricular block;
- •Severe, uncontrolled arrhythmias requiring pharmacological treatment;
- •History of chronic congestive heart failure, New York Heart Association ≥ grade 3;
- •Cardiac ejection fraction < 50% within 6 months prior to screening;
- •Heart valve disease with CTCAE ≥ grade 3;
- •ECG evidence of myocardial infarction, unstable angina, severe ventricular arrhythmias, history of severe pericardial disease, and acute ischemic or active conduction system abnormalities within 6 months prior to screening;
- •Uncontrollable hypertension (defined as a measured systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg under pharmacological control);
- •Active bacterial, fungal or viral infections that require intravenous infusion treatment within 1 week prior to the first dose;
- •Any anticancer treatment (including chemotherapy, radiotherapy, molecular targeted therapy, immunotherapy, endocrine therapy) within 4 weeks prior to the first dose, immunomodulators as adjuvant therapy for malignancy within 2 weeks prior to the first dose, any anti-tumor proprietary Chinese medicine (except for those in the category of supporting and relieving symptoms) within 2 weeks prior to the first dose;
- •Patients who enrolled in any other clinical trials within 4 weeks prior to the first dose;
- •Patients who undergone major surgery within 12 weeks before the first dose, or have a surgical schedule during the study period;
- •Patients with thrombosis or thromboembolism within 6 months prior to screening;
- •Lactating female;
- •Serious and/or uncontrolled medical condition that, in the judgment of the investigator, may affect the patient's participation in this study (including, but not limited to: diabetes not effectively controlled, kidney disease requiring dialysis, severe liver disease, life-threatening autoimmune and bleeding disorders, substance abuse, neurological disorders, etc.);
- •Not suitable for this study as decided by the investigator due to other reasons.
研究组 & 干预措施
Mitoxantrone Hydrochloride Liposome Injection
Experimental
Patients with advanced HER2 negative breast cancer will receive 20 mg/m2 Mitoxantrone Hydrochloride Liposome injection every 21 days (a cycle) for about 6 cycles.
干预措施: Mitoxantrone Hydrochloride Liposome Injection (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: From the enrollment to the final documentation of response of the last subject(assessed up to 36 months)
To investigate the preliminary antitumor efficacy
次要结局
- Overall survival (OS)(From the enrollment to death,lost to follow-up,withdrawal,or study end,whichever occurred first,assessed up to 36 months)
- Disease control rate (DCR)(From the enrollment to the final documentation of response of the last subject(assessed up to 36 months))
- Progression-free survival (PFS)(From the enrollment to death,lost to follow-up,withdrawal,or study end,whichever occurred first,assessed up to 36 months)
- Duration of response (DoR)(From the enrollment to death,lost to follow-up,withdrawal,or study end,whichever occurred first,assessed up to 36 months)
- Treatment emergent adverse events (TEAEs)(from the administration of the first dose to 28 days after the last dose)
研究者
研究点 (29)
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