EUCTR2010-022520-73-GR进行中（未招募）不适用
Phase II, open-label non-randomized trial to investigate the efficacy of Bevacizumab in combination with dose dense sequential chemotherapy in the neo-adjuvant setting for HER2 negative breast cancer patients. - Not Available
Hellenic Oncology Research Group0 个研究点开始时间: 2011年5月17日最近更新:
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
- •Female patients with histologic proven, corebiopsied, invasive ductal adenocarcinoma of the breast >2 cm in size and of any N stage (clinical and/or radiological T-stage > T1, including T4d), scheduled to receive preoperative hemotherapy.
- •Age 18-70 years
- •ECOG performance-status =1
- •No prior or current neoplasm except for curatively treated non melanoma skin cancer, in situ carcinoma of the
- •No distant disease/secondary carcinoma
- •Normal cardiac function
- •Results of the following assessments at the time of inclusion must be available:
- •- bilateral Mammography (before enrolment)
- •- histology
- •- hormone-receptor-status
- •- HER2 status negative (is defined as FISH/CISH negative or IHC0 or IHC1+, or IHC2+ and FISH/CISH negative)
- •Laboratory requirements (within 1 week before enrolment):
- •(a) Hematology: Neutrophils = 1.5 x 109/l, Platelets = 100 x 109/l, Hemoglobin>11 g/dl
- •(b) Hepatic function: Total bilirubin < 1 x ULN, ASAT (SGOT) and ALAT (SGPT) < 1.5 x ULN, Alkaline
- •phosphatases < 1.5 x ULN. In case of abnormal values, the liver function tests have to be repeated within 3 days before study treatment.
- •(c) Renal function: Creatinine < 1 x ULN
- •(d) Urinalysis: Urine dipstick of proteinuria < 2+.
- •Patients discovered to have = 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24–hour urine collection and must demonstrate <1 g of protein / 24 hours.
- •Signed and dated Informed Consent before the start of specific protocol procedures
- •If of childbearing potential, negative pregnancy test
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Cytological only confirmation of diagnosis
- •Lobular or other non-ductal types of breast cancer
- •Pregnant, or lactating patients; patients of childbearing potential must implement adequate contraceptive measures during study participation
- •Pre-existing motor or sensory neurotoxicity of a severity > grade 2 by NCI-CTC AE Version 3.0
- •Preoperative local treatment for breast cancer (i.e. incomplete surgery, radiotherapy)
- •Prior or concurrent systemic antitumor therapy
- •Evidence of wound healing complications, bone fracture, ulcer or the presence of linically significant peripheral vascular disease
- •Clinically significant cardiac disease e.g. congestive heart failure.
- •Other serious illness or medical condition -uncontrolled hypertension or high risk uncontrolled arrythmias -history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent-active uncontrolled infection -unstable peptic ulcer, unstable diabetes mellitus or other contraindication for the use of corticosteroids
- •Known hypersensitivity reaction to the compounds or incorporated substances.
- •Evidence of bleeding diathesis or coagulopathy
- •The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR, or appropriate monitoring test is within therapeutic limits and the patient has been on a stable dose of anticoagulants for at least
- •two weeks at the time of randomization. Patients not receiving anti coagulant medication must have an INR = 1.5 an aPTT = 1.5 x ULN within 7 days of randomization.
- •Ongoing treatment with aspirin (> 325mg / day) or other medications known to predispose to gastrointestinal ulceration.
- •Major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment.
- •Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion
- •Treatment with an investigational drug within 30 days prior to study entry.
- •Legally incapacitated and/or other circumstances which make it undesirable for the subject to understand the nature, meaning and consequences of the clinical study
研究者
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