EUCTR2016-001852-23-NL进行中（未招募）1 期
A feasibility study of niraparib for advanced, BRCA1-like, HER2-negative breast cancer patients - ABC study
KI-AV0 个研究点开始时间: 2016年8月31日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- 性别
- All
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;
- •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.
- •Fresh frozen primary tumor sample available or metastasis accessible for fresh frozen biopsy;
- •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 one prior line 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;
- •Measureable or evaluable disease according to RECIST 1.1 criteria (appendix 2);
- •Minimal acceptable safety laboratory values
- •o ANC of = 1.5 x 109 /L
- •o Platelet count of = 150 x 109 /L
- •o Hemoglobin = 10 g/dL (6,21 mmol/L)
- •o Hepatic function as defined by serum bilirubin = 1.5 x ULN, ASAT and ALAT < 2.5 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 potential;
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 9
排除标准
- •Any treatment with investigational drugs within 28 days prior to receiving the first dose of investigational treatment; or within 21 days for standard chemotherapy; or within 14 days for weekly scheduled chemotherapeutic regimens or endocrine therapy;
- •Patients who have progressed on previous palliative treatment with PARP1-inhibitors, platinum compounds or high dose alkylating agents with autologous stem cell rescue, since preclinical and anecdotal clinical data in breast cancer indicate that these cancers have acquired resistance to PARP-inhibitors based on genetic reversion, epigenetic modifications, or as yet unknown mechanisms. Platinum-sensitive or PARP1-inhibitor-sensitive patients who stopped for reasons other than progression are eligible;
- •Patients who received high-dose alkylating agents or platinum compounds in the (neo)adjuvant setting, unless these treatments had been received longer than 3 years ago;
- •Pretreatment not containing an anthracycline and/or taxane, either in the (neo-) adjuvant or metastatic setting received, or if not, then discussed with the patient whether it is justified to forego these treatments;
- •Women who have a positive pregnancy test (urine/serum) and/or who are breast feeding;
- •Unreliable contraceptive methods. Women and men enrolled in this trial must agree to use a reliable contraceptive method throughout the study (adequate contraceptive methods are: intra-uterine devices or systems, condom or other barrier contraceptive measures, sterilization and true abstinence: see also 3.5)
- •Radiotherapy within the last four weeks prior to receiving the first dose of investigational treatment; except 1x8 Gy for pain palliation then a seven days interval should be maintained;
- •Patients must not have any known history of myelodysplastic syndrome (MDS) or other cytogenetic abnormality associated with MDS
- •Patients must not have known persistent (> 4 weeks) = Grade 2 toxicity from prior cancer therapy
- •Patients must not have known = Grade 3 hematological toxicity with the last chemotherapy regimen
- •Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients;
- •Patients with an active hepatitis B or C;
- •Recent myocardial infarction (< six months) or unstable angina;
- •Symptomatic brain or leptomeningeal metastases. If adequately treated with resection and/or irradiation and patients are at least four weeks completely free of symptoms of these metastases with or without corticosteroids, patients could be eligible if all other in- and exclusion criteria are obeyed.
- •Any medical condition not yet specified above that is considered to possibly, probably or definitely interfere with study procedures, including adequate follow-up and compliance and/or would jeopardize safe treatment.
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