EUCTR2018-001213-32-ES进行中（未招募）1 期
Effectiveness of olaparib plus trastuzumab in HER2-positive BRCA-mutated or Homologous Recombination Deficiency (HRD) advanced breast cancer patients – The OPHELIA Study – - OPHELIA
Medica Scientia Innovation Research (MedSIR)0 个研究点目标入组 33 人开始时间: 2018年11月16日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 33
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. Provision of informed consent prior to any study specific procedures.
- •2. Male or female =18 years of age at the time of signing the Informed Consent Form (ICF).
- •3. Histologically and/or cytologically confirmed breast cancer with evidence of advanced disease (locoregionally recurrent or metastatic) not amenable to resection or radiation therapy with curative intent.
- •4. Patients with histologically and/or cytologically locally confirmed diagnosis of Human Epidermal Growth Factor Receptor 2 (HER2)-positive breast cancer according to the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) 2013
- •5. [Cohort A]: Patients with documented germinal mutation in Breast Cancer (BRCA)1 or BRCA2 genes that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function). Patients with germinal BRCA1/2 mutations that are considered to be non-detrimental (e.g., Variants of uncertain clinical significance” or Variant of unknown significance” or Variant, favor polymorphism” or benign polymorphism,” etc.) will not be eligible for the study. Patients with known germinal BRCA status prior to enrollment are considered eligible to participate.[Exploratory cohort B]: Patients with wild-type germinal BRCA1/2 genes with Homologous Recombination Deficiency (HRD)-positive status based on HRDetect test.
- •6. History of progression on HER2-directed therapy for the treatment of HER2-positive breast cancer with not more than three prior regimens of chemotherapy and/or trastuzumab-lapatinib in advanced scenario, and at least one regimen of chemotherapy
- •including trastuzumab.
- •7. Eastern Cooperative Oncology Group (ECOG) performance status score = 1.
- •8. Life expectancy greater or equal to 16 weeks.
- •9. Patients must have evaluable or measurable disease by Computed Tomography (CT) scan or Magnetic resonance imaging (MRI), according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
- •10. Patients must have normal organ and bone marrow function within 35 days prior to administration of study treatment as defined below: • Hematological: White blood cell (WBC) count >3.0 x 109/L, absolute neutrophil count (ANC) =1.5 x 109/L, platelet count
- •=100.0 x109/L, and hemoglobin = 10 g/dL with no blood transfusions (packed red blood cells and platelet transfusions in the past 35 days are permitted). • Hepatic: bilirubin = 1.5 times the upper limit of normal (x ULN) (=2.0 in patients with known Gilberts syndrome) or direct bilirubin = 1 x ULN; alkaline phosphatase (ALP), Aspartate aminotransferase (AST) / Serum Glutamic Oxaloacetic Transaminase (SGOT), and Alanine aminotransferase (ALT) / Serum Glutamic Pyruvate Transaminase (SGPT) = 2.5 x institutional ULN unless liver metastases are present, in which case they must be = 5 x ULN. • Renal: Serum creatinine = 1.5 x ULN or based on a 24-hour urine test or estimated creatinine clearance = 51 mL/min using the Cockcroft-Gault equation: Estimated creatinine clearance = (140-age [years]) x weight (kg) (x F)a serum creatinine (mg/dL) x 72a where F=0.85 for females and F=1 for males.
- •11. Patients have been informed about the nature of study, including the exploratory studies and has agreed to participate and si
排除标准
- •1.Patients that have previously received any poly(ADP-ribose) polymerase (PARP)inhibitor (PARPi)for any reason,including olaparib
- •2.Previous treatment with carboplatin or other platinum containing compounds in the last 12 months prior to entry to the study
- •3.Patients who have not received any previous chemotherapy in the advanced setting
- •4.Involvement in the planning and/or conduct of the study
- •5.Previous enrolment in the present study
- •6.Patients simultaneously enrolled in any interventional clinical trial
- •7.Patients who have received any systemic chemotherapy during the last 3 weeks prior initiating protocol therapy
- •8.Patients who have had radiation therapy encompassing>20%of the bone marrow within 3 weeks prior to start of treatment,excepting for palliative radiation therapy to a small field>1-week prior to Day 1 of study
- •9.Resting ECG indicating uncontrolled,potentially reversible cardiac conditions,as judged by the investigator or patients with congenital long QT syndrome
- •10.Patients with symptomatic visceral disease are not eligible
- •11.Concomitant use of known strong Cytochrome P450 (CYP)3A inhibitors or moderate CYP3A inhibitors.The required washout period prior to starting olaparib is 2 weeks
- •12.Concomitant use of known strong or moderate CYP3A inducers.The required washout period prior to starting study treatment is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents
- •13.Persistent toxicities CTCAE grade 2)caused by previous cancer therapy,excluding alopecia
- •14.Patients with Myelodysplastic syndrome(MDS)/Acute myeloid leukemia(AML)or with features suggestive of MDS/AML
- •15.Patients having diagnosis,detection,or treatment of another type of cancer during the last 5 years prior to initiating protocol therapy(except adequately treated non-melanoma skin cancer,curatively treated in situ cancer of the cervix,definitively treated ductal carcinoma in situ,stage 1,grade 1 endometrial carcinoma),or other solid tumors including lymphomas(without bone marrow involvement)curatively treated with no evidence of disease for =5 years)
- •16.Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery
- •17.Patients considered a high medical risk due to a serious,uncontrolled medical disorder,non-malignant systemic disease or active,uncontrolled infection
- •18.Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication
- •19.Immunocompromised patients
- •20.Patients with a known hypersensitivity to olaparib or trastuzumab or any of the excipients of the products
- •21.Clinically significant cardiovascular disease(stroke, unstable angina pectoris,or documented myocardial infarction)within 6 months prior to study entry;history of documented congestive heart failure(New York Heart Association II-III-IV);symptomatic pericarditis;documented cardiomyopathy;ventricular arrhythmias with the exception of benign premature ventricular contractions;conduction abnormality requiring a pacemaker;other arrhythmias not controlled with medication
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