EUCTR2014-000156-28-PL进行中（未招募）1 期
A MULTICENTER, MULTINATIONAL, PHASE II STUDY TO EVALUATE PERJETA® IN COMBINATION WITH HERCEPTIN® AND STANDARD NEOADJUVANT ANTHRACYCLINE-BASED CHEMOTHERAPY IN PATIENTS WITH HER2-POSITIVE, LOCALLY ADVANCED, INFLAMMATORY, OR EARLY-STAGE BREAST CANCER - BERENICE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 401
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
- •- Adult patients, = 18 years of age
- •- HER2-positive breast cancer confirmed by a central laboratory
- •- Primary tumor > 2 cm in diameter, or > 5 mm in diameter and node-positive
- •- Eastern Cooperative Oncology Group (ECOG) performance status =1
- •- Baseline LVEF = 55% (measured by ECHO or MUGA)
- •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 367
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 33
排除标准
- •- Any previous systemic therapy (including chemotherapy, immunotherapy, HER2-targeted agents, and antitumor vaccines) for cancer, or radiation therapy for cancer
- •- Metastatic disease (Stage IV) or bilateral breast cancer
- •- Previous exposure to any investigational treatment within 4 weeks before the first dose of study treatment
- •- Prior breast or non-breast malignancy within 5 years prior to study
- •entry, except for carcinoma in situ and basal cell and squamous cell
- •carcinoma of the skin. Patients with malignancies occurring more than 5
- •years prior to study entry are permitted if curatively treated.
- •- Inadequate hematologic, renal or liver function
- •- Pregnant or lactating women
- •- History of congestive heart failure of any New York Heart Association (NYHA) criteria
- •- angina requiring anti-anginal medication
- •- history of myocardial infarction within 6 months of enrollment
- •- serious or uncontrolled cardiac arrhythmia requiring treatment
- •- History or evidence of poorly controlled hypertension
- •- Severe, uncontrolled systemic disease
- •- Positive for hepatitis B, hepatitis C or HIV infection
研究者
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