EUCTR2007-000124-41-DE进行中（未招募）不适用
Phase II study of neoadjuvant epirubicin, cyclophosphamide (EC) + sorafenib followed by paclitaxel (P) + sorafenib in women with previously untreated primary breast cancer - Sofia
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
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
- •- Written informed consent for all study procedures including an additional core biopsy after the first 4 cycles of EC must be obtained and documented according to the local regulatory requirements;
- •- Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy. Fine-needle aspiration is not sufficient. Incisional biopsy is not allowed. In case of bilateral cancer the investigator has to decide prospectively which side will be evaluated for the primary endpoint;
- •- Tumor lesion in the breast with a palpable size of >= 2 cm. The lesion has to be measurable in two-dimensions preferably by sonography. In case of inflammatory disease the extent of inflammation can be used as measurable lesion;
- •- Patients should have stages of disease in which adjuvant chemotherapy would be considered. The following tumor stages are eligible:
- •Locally advanced tumors with cT4 or cT3 or
- •Tumors with cT2 cN+
- •In patients with multifocal or multicentric breast cancer, the largest lesion should be measured;
- •- Age >= 18 years
- •- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment;
- •- Negative HER-2/neu status
- •- Karnofsky Performance status index >=80%;
- •- Normal cardiac function must be confirmed by ECG and cardiac ultrasound (LVEF or shortening fraction) within 3 months prior to registration. Results must be above the normal limit of the institution and above 55%;
- •- Laboratory requirements: (within 14 days prior to registration)
- •Absolute neutrophile count (ANC) >= 2,0 x 10^9/L and
- •Platelets >= 100 x 10^9/L and
- •Hemoglobin >= 10 g/dL (>= 6.2 mmol/L)
- •INR = 1.5 ULN and PTT = 1.5 ULN within 14 days prior to enrolment
- •ASAT or ALAT < 2.5 x ULN
- •Alkaline phosphatase = 5 UNL. Patients with ASAT and/or ALAT > 1,5 x UNL associated with alkaline phosphatase > 2,5 x UNL are not eligible for the study
- •Total bilirubin < 1 X UNL
- •Creatinine = 175 µmol/L (2 mg/dl). The calculated creatinine clearance should be = 60 mL/min.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Evidence of distant metastasis;
- •- Prior chemotherapy for any malignancy;
- •- Prior radiation therapy for breast cancer;
- •- Preexisting rhagades at hand and feet and other skin problems (e.g psoriasis)
- •- Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intra uterine contraceptive devices, sterilization) during study treatment;
- •- Pre-existing motor or sensory neuropathy of a severity >= grade 2 by NCI criteria;
- •- Other serious illness or medical condition:
- •Previous malignant disease without being disease-free of less than 5 years (except CIS of the Cervix and non-melanomatous skin cancer)
- •Known or suspected congestive heart failure (=NYHA II) and/or coronary heart disease, angina pectoris requiring antianginal medication, previous history of myocardial infarction within past six months, evidence of transmural infarction on ECG, un- or poorly controlled arterial hypertension (systolic blood pressure >150 mm Hg or > 90 mmHg diastolic blood pressure under treatment with two antihypertensive drugs), rhythm abnormalities requiring permanent treatment, clinically significant valvular heart disease
- •Thrombotic or embolic events including transient ischemic attacks within the past six months
- •Hemorrhage/bleeding event = Grade 3 within 4 weeks prior study entry
- •Evidence or history of bleeding diathesis or coagulopathy
- •History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent
- •Major surgery, open biopsy or significant traumatic injury within 28 days of first dose of study drug
研究者
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