Phase II Study of Fluvestrant Combined With Oral Vinorelbine in Hormone Receptor-positive Advanced Breast Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This is a single-center phase II study designed to evaluated the efficacy and safety of fulvestrant in combination with oral vinorelbine in hormone receptor-positive advanced breast cancer
详细描述
This is a single-group, single-center phase II trial. Patients with hormone-receptor-positive, Her2-negative recurrent or metastatic breast cancer who had not previously received any systemic antitumor therapy for advanced disease were treated with fulvestrant combined with oral vinorelbine as a first-line regimen. Key issues to be addressed in this study: to observe and evaluate the efficacy and safety of fulvestrant combined with oral vinorelbine in the treatment of hormone-receptor-positive and HER2-negative advanced breast cancer. Thirty patients are planned to be enrolled.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 year-old women; Pathologically or cytologically confirmed breast cancer; Hormone receptor-positive
- •ECOG score: 0-1, expected survival time ≥ 3months;
- •Recurrence after adjuvant therapy or metastatic breast cancer and chemotherapy naïve in the metastatic setting or had one prior regimen for metastatic breast cancer.
- •Patients must have measurable disease according to RECIST criteria Version 1.
- •Bone metastases lesions were excluded.
- •The patients have adequate hematologic and organ function.
排除标准
- •Patients with symptomatic brain metastases.
- •Patients who are known or suspected to be allergic to the active ingredient or excipients of the investigational drug.
- •Received ≥1 standard chemotherapy regimen (excluding endocrine therapy) for advanced breast cancer.
- •Participation in other clinical trials within 4 weeks before enrollment.
- •Severe cardiovascular disease, including history of congestive heart failure, acute myocardial infarction within 6 months before enrollment, transmural myocardial infarction measured by ECG, uncontrolled arrhythmia, angina requiring therapy, clinically significant valvular heart disease, uncontrolled hypertension.
- •Severe or uncontrolled infection.
- •Any factors that affect the oral administration and absorption of drugs (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.);
- •Active malignancy in the past 5 years (other than carcinoma in situ of the cervix or basal cell carcinoma of the skin).
- •Patients who are pregnant , breastfeeding ,or refuse to use adequate contraception during the course of participation.
- •Need to concurrent other cancer therapy(other than palliative care for non-target lesions).
- •Other ineligible conditions according to the researcher's judgment.
研究组 & 干预措施
Single arm
Fluvestrant in combination with oral Vinorelbine Fluvestrant: administered at a dose of 0.5g once im every 28 days. Vinorelbine: administered at a dose of 60mg/kg once a week for 3 weeks p.o. every 28 days.
干预措施: fluvestrant + oral vinorelbine (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: approximately 1.5 years
PFS will be defined as the time from first dose of study drug until documentation of disease progression or death from any cause
次要结局
- Objective response rate (ORR)(approximately 6 months)
- Incidence and Severity of adverse events(approximately 1.5 years)
研究者
Peng Yuan
Principal Investigator
Chinese Academy of Medical Sciences