EUCTR2009-009874-28-AT进行中（未招募）不适用
Epirubicine plus Cyclophosphamid followed by Docetaxel +/- Sunitinib before surgery for the treatment of patients with HER2neu-negative operable breast cancer
ABCSG - Austrian Breast & Colorectal Cancer Study Group0 个研究点开始时间: 2009年4月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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 with histologically or cytologically diagnosed HER2neu-negative (FISH negative or IHC 0 or +1) invasive cancer of the breast scheduled to receive chemotherapy (FEC/EC, Docetaxel)
- •- Stage I, II or Stage III (T1-4a-c, N0-N3 and M0)
- •- No prior chemotherapy, radiotherapy, or endocrine therapy for invasive or noninvasive breast cancer
- •- 18 years of age or older
- •- ECOG performance status 0, 1
- •- Adequate organ function as defined
- •- Signed and dated informed consent
- •- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- •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
- •- Metastatic disease
- •- Her-2/neu overexpressing breast cancer
- •- Lobular breast cancer except triple-negative tumors
- •- Inflammatory carcinoma (T4d)
- •- Prior treatment for breast cancer or current treatment with another antitumor therapy
- •- Other malignancy within the last 5 years before randomization except for curatively treated non melanoma skin cancer and in situ carcinoma of the cervix
- •- Patients for whom Docetaxel is contraindicated according to the local prescribing information
- •- Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular incident including transient ischemic attack, or pulmonary embolus.
- •- Ongoing cardiac dysrhythmias of grade >2, atrial fibrillation of any grade, or QTc interval >470 msec.
- •- Hypertension that cannot be controlled by medication (>150/100 mm Hg despite optimal medical therapy).
- •- Current treatment with therapeutic doses of Phenprocoumon (low dose Phenprocoumon up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
- •- Concomitant use of drugs with dysrhythmic potential
- •- Pre-treatment with Sunitinib
- •- Concurrent participation in another clinical trial evaluating the same end point
- •- Known human immunodeficiency virus infection.
- •- Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to study entry. In addition pregnancy tests must be performed at least monthly during therapy and at the end of the therapy in pre-menopausal patients. In post-menopausal patients see protocol section 7.1 Screening.
- •- Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
研究者
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