NL-OMON47829已完成2 期
A feasibility study of niraparib for advanced, BRCA1-like, HER2-negative breast cancer patients: the ABC study - ABC study
ederlands Kanker Instituut0 个研究点目标入组 39 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational invasive
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Histological proof of advanced, HER2 negative breast cancer;
- •* The tumor must be BRCA1-like, as identified by Agendia*s RNA-based BRCAness
- •classifier;with a maximum of 25% of the study population in each stage.
- •* Only the following patients may be referred for BRCA1-like testing: all
- •patients that had triple negative primary breast cancer; hormone-receptor
- •positive, HER2-negative primary breast cancer patients with a histological
- •grade III breast cancer; Breast cancer patients carrying a BRCA1 and/or BRCA2
- •germ line mutation.
- •* Pretreatment containing an anthracycline and/or taxane in the (neo-)adjuvant
- •or metastatic setting received, or if not, then discussed with the patient
- •whether it is justified to forego these treatments;
- •* Maximum of two prior lines of chemotherapy for advanced disease.
- •* Age * 18 years;
- •* Able and willing to give written informed consent;
- •* WHO performance status of 0, 1 or 2;
- •* Life expectancy * 3 months, allowing adequate follow up of toxicity
- •evaluation and antitumor activity;
- •* Measurable or evaluable disease according to RECIST 1.1 criteria;
- •* Minimal acceptable safety laboratory values
- •-ANC of * 1.5 x 109 /L
- •-Platelet count of * 150 x 109 /L
- •-Hemoglobin * 10 g/dL (6.21mmol/L)
- •-Hepatic function as defined by serum bilirubin * 1.5 x ULN, ASAT and ALAT <
- •2.5 x ULN; Subjects who have obligatory liver toxic medication or liver
- •steatosis should have values < 5 x ULN.
- •* Renal function as defined by serum creatinine * 1.5 x ULN or creatinine
- •clearance * 50 mL/min (by Cockcroft-Gault formula);
- •* Negative pregnancy test (urine/serum) for female patients with childbearing
排除标准
- •* Any systemic anticancer treatment within 14 days prior to receiving the first
- •dose of investigational treatment; , except for endocrine therapy that may be
- •continued up to 1 week before start niraparib
- •* Patienten met progressive op eerdere palliatieve behandeling met
- •PARP1-remmers, platina bevattende behandeling of hoge dosis alkylerende
- •middelen met stam cel transplanatatie.
- •Platinum-gevoelige of PARP1-remmer-gevoelige patienten die om andere reden dan
- •progressive zijn gestopt zijn wel eligible;
- •* Patienten die hoge dosis alkylerende midelen met autologe stam cel
- •transplantatie hebben gehad in (neo)adjuvante setting, tenzij deze behandleing
- •meer dan 3 jaar geleden is gegeven;
- •*Voorbehandeling bevat geen anthracycline en/of taxane, in de (neo-) adjuvante
- •of gemetastaseerde setting tenzij deze behandelingen gecontraindiceerd zijn;
研究者
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