EUCTR2013-002662-40-IT进行中（未招募）1 期
PERtuzumab-trastuzumab plus lEetrozoLe In endocrine Sensitive breast cancer: a phase II neoAdjuvant study - PER-ELISA
AS.T.R.O.0 个研究点目标入组 68 人开始时间: 2013年7月5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
- 68
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
- Female
入选标准
- •Patients may be included in the study only if they met all the following criteria
- •- female patients with primary diagnosis of infiltrating breast cancer
- •- HR positivity (ER = 10% and/or PgR =10%) and HER2 positivity (IHC 3+ or FISH/CISH amplification) as assessed by local laboratory
- •- Stage II-IIIA
- •- age >18 yrs
- •- ECOG Performance Status 0-1
- •- Postmenopausal status, defined by at least one of the following:
- •60 years of age;
- •< 60 years of age and amenorrheic for >/=12 months prior to day 1
- •< 60 years of age, without a uterus, and luteinizing hormone (LH) and follicle stimulating hormone (FSH) values within postmenopausal range
- •Prior bilateral oophorectomy
- •Prior radiation castration with amenorrhea for at least 6 months
- •- Cardiac ejection fraction within the institutional range of normal (as measured by echocardiogram or MUGA scan).
- •- Normal organ and marrow function as defined below:
- •(leukocytes >=3000/mcL;
- •absolute neutrophil count >=1,500/mcL;
- •platelets >=100,000/mcL;
- •total bilirubin within 1.25 x normal institutional limits (with the exception of Gilbert’s syndrome);
- •AST (SGOT)/ALT(SGPT) within 1.25 x institutional upper limit of normal
- •creatinine within normal institutional limits
- •- Availability of tumor tissue suitable for biological and molecular examination before starting primary treatment
- •- Ability to understand and the willingness to sign a written informed consent document.
- •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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 23
排除标准
- •Patients will be excluded from the study for any of the following reasons
- •- Stage IIIB, IIIC, and inflammatory breast cancer
- •- Stage IV breast cancer
- •- Prior treatment with chemotherapy, endocrine therapy or radiotherapy. Prior treatment with HER2 targeting therapies
- •- LVEF below the ULN
- •- Uncontrolled hypertension (systolic >150 mm Hg and/or diastolic >100 mm Hg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident (CVA)/stroke or myocardial infarction within 6 months prior to first study medication, unstable angina, congestive heart failure (CHF) of New York Heart Association (NYHA) grade II or higher, or serious cardiac arrhythmia requiring medication.
- •- Received any investigational treatment within 4 weeks of study start.
- •- Subjects with known infection with HIV, HBV, HCV
- •- Known hypersensitivity to any of the study drugs or excipients.
- •- Dyspnea at rest or other disease requiring continuous oxygen therapy.
- •- Psychiatric illness/social situations that would limit compliance with study requirements
- •- Subjects assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
研究者
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