EUCTR2014-000156-28-FR进行中（未招募）1 期
A MULTICENTER, MULTINATIONAL, PHASE II STUDY TO EVALUATE PERTUZUMAB IN COMBINATION WITH TRASTUZUMAB AND STANDARD NEOADJUVANT ANTHRACYCLINE-BASED CHEMOTHERAPY IN PATIENTS WITH HER2-POSITIVE, LOCALLY ADVANCED, INFLAMMATORY, OR EARLY-STAGE BREAST CANCER - BERENICE
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 33
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 367
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
- •- History of non-breast malignancies within 5 years prior to study entry, except for carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
- •- 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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