EUCTR2016-002676-27-ES进行中（未招募）1 期
Chemotherapy-free trastuzumab and pertuzumab in HER2-positive breast cancer: FDG-PET response-adapted strategy. The PHERGain study - PHERGain
Medica Scientia Innovation Research (MedSIR)0 个研究点目标入组 400 人开始时间: 2017年3月23日最近更新:
适应症
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
- 400
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
- •1)Written informed consent prior to beginning specific protocol procedures.
- •2)Female or male patients = 18 years of age.
- •3)Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- •4)Histologically proven invasive breast cancer.
- •5)Operable breast cancer (cT1-3 and/or cN0-2 tumors).
- •6)Tumor size larger than or equal to 1.5 centimeter (cm) in diameter by magnetic resonance imaging (MRI) or ultrasound with a significant 18F-FDG uptake defined as maximum standardized uptake value (SUVmax) =1.5 x SUVmean liver + 2 SD.
- •Multicentric/multifocal tumors will be allowed only if:
- •1. Histological confirmation of at least two lesions.
- •2. All tumors must be HER2-positive.
- •3. Largest lesion must be larger than or equal to 1.5 cm in diameter by MRI or ultrasound.
- •7)Centrally confirmed HER2-positive disease according to the 2013 American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) criteria.
- •8)Patient must have known estrogen receptor (ER) and progesterone receptor (PR) status locally determined prior to study entry.
- •Patient has adequate bone marrow, liver, and renal function:
- •9)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 = 10.0 g/dL (= 6.2 mmol/L).
- •10)Hepatic: total bilirubin = institutional upper limit of normal (ULN) (except for Gilbert’s syndrome); alkaline phosphatase (ALP) = 2.5 times ULN; aspartate transaminase (AST) and alanine transaminase (ALT) = 1.5 times ULN.
- •11)Renal: serum creatinine = 1.5 x ULN or creatinine clearance = 50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
- •12)Patient must be accessible for treatment and follow-up.
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
排除标准
- •1)Previous treatment with chemotherapy, anti-HER2 therapy, radiation therapy, or endocrine therapy for invasive breast cancer.
- •2)cT4 and/or cN3 tumors.
- •3)Bilateral breast cancer.
- •4)Evidence of metastatic disease by routine clinical assessment ?chest x-ray, liver ultrasound, and bone scan; or computed tomography (CT) scan of thorax and abdomen and bone scan?, except patients with subclinic M1 at baseline only according to 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) that will be allowed to be included into Cohort C.
- •5)Known hypersensitivity reaction to any investigational or therapeutic compound or their incorporated substances.
- •6)History of other malignancy within the last five years prior to first dose of study drug administration, except for curatively treated basal and squamous cell carcinoma of the skin and/or in situ cervical carcinoma.
- •7)Left ventricular ejection fraction (LVEF) below 55% as determined by multiple-gated acquisition (MUGA) scan or echocardiography (ECHO).
- •8)Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg) despite adequate antihypertensive treatment.
- •9)Clinically significant cardiovascular disease [stroke, unstable angina pectoris, or documented myocardial infarction within six months prior to study entry; history of documented congestive heart failure (CHF) (New York Heart Association II-III-IV); symptomatic pericarditis; documented cardiomyopathy; ventricular arrytmhias with the exception of benign premature ventricular contractions; conduction abnormality requiring a pacemaker; other arrhythmias not controlled with medication].
- •10)Active uncontrolled infection at the time of enrollment.
- •11)Current known infection with HIV, hepatitis B virus, or hepatitis C virus.
- •12)Patients with pulmonary disease requiring continuous oxygen therapy.
- •13)Previous history of bleeding diathesis.
- •14)Patient is currently receiving anti-coagulant therapy, chronic treatment with corticosteroids, or another immunosuppressive agent (standard premedication for chemotherapy and local applications are allowed).
- •15)Major surgical procedure or significant traumatic injury within 14 days prior to randomization or anticipation of need for major surgery within the course of the study treatment.
- •16)Patient has other concurrent severe and/or uncontrolled medical condition that would, in the investigator´s judgment, contraindicate her participation in the clinical study.
- •17)Concurrent participation in other clinical trial, except other translational studies.
- •18)History of receiving any investigational treatment within 28 days prior to randomization.
- •19)Pregnant or breast-feeding women or patients not willing to apply highly effective contraception as defined in the protocol.
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