Safety and Efficacy of Eribullin or Eribulin Combined With Anlotinib in Metastatic Breast Cancer Patients: An Open-Labeled, Single-center, Prospective Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Progression-Free Survival
研究概览
简要总结
Eribulin is the promising agent for late-line metastatic breast cancer patients. The aim of this Phase II, double-arm, open-label and prospective clinical trial is to assess the efficacy and safety of Eribullin or Eribulin combined with Anlotinib in patients with metastatic breast cancer
详细描述
The aim of the double-arm, open-label, phase II clinical trial is to assess efficacy and safety of Eribulin or Eribulin combined with Anlotinib in metastatic breast cancers. The investigator hypothesize that both Eribulin and Eribulin combined with Anlotinib may be an effective alternative treatment for metastatic breast cancers. In addition, Eribulin combined with Anlotinib might be able to improve the treatment response and progression-free survival.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old, voluntary consent and signed written informed consent
- •ECOG 0~2
- •Pathologically diagnosed HER2-negative breast cancer patients with radiologically confirmed locally advanced (stage IIIB or IIIC) or metastatic (stage IV) breast cancer; HR-positive patients were permitted
- •At least one measurable disease lesion before treatment
- •Never receive Eribulin Mesylate treatment or anti-angiogenetic therapies before recruitment
- •Anticipated survival time is longer than three months
- •Brain metastases with stable disease or without clinical symptom
- •Blood routine test, liver and kidney function test meet the following criteria: PLT > 100g / L, Hb > 9g / L, Neutrophil > 2.0 g/L; AST and ALT < 2.5 upper limit of normal (ULN); Cr < 1.0 ULN; TBIL < 1.5ULN
- •Previously treated with anthracycline-based and taxane-based chemotherapy regimens (at least one line of chemotherapy in the metastatic setting or the recurrence time is less than 1 year from the end of adjuvant or neoadjuvant chemotherapy); for HR-positive/HER2-negative patients, progressed after at least one line of endocrine therapy
- •For women with fertility, the pregnancy test before administration was negative, and agreed to take appropriate measures to avoid pregnancy during the study treatment and at least half a year after the end of treatment; Men agreed to take appropriate contraceptive measures during the study treatment and at least half a year after the end of the treatment.
排除标准
- •Pregnant or lactating women
- •Active infection requiring systemic treatment
- •HIV positive
- •Suffering from or suspected of suffering from central neuromuscular system diseases
- •Serious heart disease; uncontrollable hypertension; history of heavy hemorrhea；recent operation within three months
- •The investigator considered that the patient was not suitable for in this study, with any other situation.
研究组 & 干预措施
Eribulin mesylate
Metastatic breast cancer patients receive eribulin mesylate injection alone. The dosage is 1.4mg/m2 for one cycle. Injection is performed on Day 1 and Day 8 of a treatment cycle. Patients receive Eribulin untill progression.
Patients were observed for at least 6 months but no longer than 18 months.
干预措施: Eribulin Mesylate (Drug)
Eribulin mesylate combined with Anlotinib
Metastatic breast cancer patients receive Eribulin mesylate combined with Anlotinib. The dosage of Eribulin mesylate is 1.4mg/m2 for one cycle. Injection is performed on Day 1 and Day 8 of a treatment cycle.
Anlotinib dosage is 12mg per day for consecutive 14 days (21 days per cycle). Patients receive Anlotinib untill progression.
Patients were observed for at least 6 months but no longer than 18 months.
干预措施: Eribulin Mesylate (Drug)
Eribulin mesylate combined with Anlotinib
Metastatic breast cancer patients receive Eribulin mesylate combined with Anlotinib. The dosage of Eribulin mesylate is 1.4mg/m2 for one cycle. Injection is performed on Day 1 and Day 8 of a treatment cycle.
Anlotinib dosage is 12mg per day for consecutive 14 days (21 days per cycle). Patients receive Anlotinib untill progression.
Patients were observed for at least 6 months but no longer than 18 months.
干预措施: Anlotinib (Drug)
结局指标
主要结局
Progression-Free Survival
时间窗: through study completion, up to 6 months.
The time from the date of recruitment to the date of first documented progression or date of death from any cause
次要结局
- Objective response rate (ORR)(At the end of Cycle 2 (42 days).)
- Disease Control Rate (DCR)(At the end of Cycle 2 (42 days).)
- Overall survival (OS)(through study completion, an average of 2 year)
- Patient Report Outcome (PRO)(through study completion, up to 6 months.)
- Adverse Events(through study completion, up to 6 months.)