EUCTR2014-004112-11-GB进行中（未招募）1 期
ALERT: A phase II study of alternating eribulin and hormonal therapy in pre-treated ER+ve breast cancer - ALERT
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Written informed consent prior to admission to this study
- •2. Aged 18=over
- •3. Histologically confirmed ER positive metastatic breast cancer according to
- •local criteria.
- •4. ECOG performance status 0 – 2
- •5. Have progressed after at least one hormonal therapy regime and at least one
- •chemotherapy regime for advanced disease
- •6. Patients must have had prior treatment with an anthracycline and a taxane
- •(either sequential or in combination) unless patients weren’t suitable for
- •these treatments. This treatment can be in the adjuvant setting
- •7. Measurable sites of locally advanced and/or metastatic disease that can be
- •accurately assessed by CT/MRI scan at baseline (RECIST v1.1)¹
- •8. Life expectancy of =6 months
- •9. Adequate organ function, as defined by:
- •Haemoglobin (Hb) =9g/dL
- •Absolute Neutrophil Count (ANC) =1.5x109/L
- •Platelet count (Plts) =100x109/L
- •White Blood Cell (WBC) =3.0 x 109/L
- •Serum albumin = 1.5 ULN
- •Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) = 3 x ULN
- •if no demonstrable liver metastases or = 5 x ULN in the presence of liver
- •metastases.
- •ALP = 5 x ULN
- •Total bilirubin = 1.5 x ULN if no demonstrable liver metastases or = 3 x ULN in
- •the presence of liver metastases
- •Creatinine = 1.5 x ULN or creatinine clearance >50ml/min
- •10. Postmenopausal as defined by age >50, no menstruation for >2 years, previous
- •oophorectomy or lab results confirming this status
- •11. Premenopausal if has been subject to ovarian ablation/ suppression at least 3
- •weeks prior to commencing AI therapy
- •¹RECIST v1.1 updated and now considers bone metastasis with an identifiable soft tissue mass to be measurable disease. Therefore, patients with bone metastasis are eligible, provided they have evaluable disease.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 8
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •1. Triple negative or HER2 positive cancer
- •2. Hypersensitivity to the active substance or to any of its excipients
- •3. History of another primary malignancy within 5 years prior to starting study
- •treatment, except adequately treated basal or squamous cell carcinoma of the
- •skin, carcinoma in site and the disease under study
- •4. Evidence of uncontrolled active infection
- •5. Severe hepatic impairment (Child-Pugh C)
- •6. Evidence of significant medical condition or laboratory finding which, in the
- •opinion of the Investigator, makes it undesirable for the patient to
- •participate in the trial
- •7. Concurrent therapy with any other investigational agent or everolimus
- •8. Concomitant use within 14 days prior to commencement of study treatment of any
- •investigational agent
- •9. Uncontrolled abnormalities of serum potassium, sodium, calcium (corrected)
- •phosphate or magnesium levels
- •10. Pregnant or lactating women. Effective non-hormonal contraception is
- •mandatory for all patients of reproductive potential
- •11. Evidence of ovarian activity
- •12. Prior eribulin therapy
研究者
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