EUCTR2004-002030-19-AT进行中（未招募）1 期
A randomized phase III study comparing epirubicin, docetaxel and capecitabine + G-CSF to epirubicin and docetaxel + G-CSF as neoadjuvant treatment for early HER-2 negative breast cancer and comparing epirubicin, docetaxel and capecitabine + G-CSF ± trastuzumab to epirubicin and docetaxel + G-CSF ± trastuzumab as neoadjuvant treatment for early HER-2 positive breast cancer - ABCSG Studie 24
AUSTRIAN BREAST CANCER STUDY GROUP0 个研究点目标入组 536 人开始时间: 2005年1月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 536
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
- •1. Female patients with histologic proven, core-biopsied, invasive breast cancer of any clinical and/or radiological T-stage (except T4d =inflammatory breast cancer) scheduled to receive preoperative chemotherapy. Patients with bilateral breast cancer can take part in the study if both tumours are histological proven.
- •2. Age 18-70 years
- •3. WHO performance-status < 2
- •4. No prior or current neoplasm except for curatively treated non melanoma skin cancer, in situ carcinoma of the cervix
- •except curatively treated non melanoma skin cancer or in situ cervical cancer
- •5. No distant disease/secondary carcinoma judged clinically and at least by chest X-ray, liver-sonography, and bone scan at the time of randomisation.
- •6. No medical and/or cardiologic contraindication to receive an anthracyclin- and taxan-containing chemotherapy regimen. Normal cardiac function must be confirmed by LVEF (echocardiography or Muga scan). The result must be above 50 % or above the lower normal limit of the institution
- •7. Results of the following assessments at the time of randomisation must be available:
- •- anamnesis and physical examination (within 4 weeks before enrolment)
- •- CT of thorax (within 4 weeks before enrolment)
- •- CT of abdomen (within 4 weeks before enrolment)
- •- bilateral Mammography (within 4 weeks before enrolment)
- •- Laboratory requirements (within 2 weeks before enrolment):
- •(a) Hematology: Leukocytes * 4.0 x 109/l, Platelets * 150 x 109/l,
- •(b) Hepatic function : Total bilirubin < 1.5 x ULN, ASAT (SGOT) and ALAT (SGPT) < 1.25 x ULN, Alkaline phosphatases < 1 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
- •- histology
- •- hormone-receptor-status
- •- HER2 status
- •8. Signed and dated Informed Consent before the start of specific protocol procedures
- •9. If of childbearing potential, negative pregnancy test.
- •10a. Assessment of HER-2 receptor: Patients may have HER-2 negative or positive disease. HER-2 positive disease is defined as HER-2 over expression measured by immunohistochemistry IHC3+ and/or by HER-2 gene amplification according to fluorescent in situ hybridization (FISH) or chromogenic in-situ hybridization (CISH).
- •10b. Patients randomized to receive trastuzumab must have HER-2 positive disease
- •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 536
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 536
排除标准
- •1. Stage T4d/ inflammatory breast cancer
- •2. Pregnant, or lactating patients; patients of childbearing potential must implement adequate contraceptive measures during study participation except hormonal methods incl. oral contraceptives, 3-month Depo-Provera shots, monthly injections, implants, contraceptive patches
- •3. Pre-existing motor or sensory neurotoxicity of a severity > grade 2 by WHO criteria
- •4. Preoperative local treatment for breast cancer (i.e. incomplete surgery, radiotherapy)
- •5. Prior or concurrent systemic antitumor therapy
- •6. Other serious illness or medical condition
- •(a) congestive heart failure or unstable angina pectoris even if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high risk uncontrolled arrythmias
- •(b) history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent
- •(c) active uncontrolled infection.
- •(d) unstable peptic ulcer, unstable diabetes mellitus or other contraindication for the use of corticosteroids
- •7. Concurrent treatment with corticosteroids except as use for the prophylactic medication regimen, inhalational use, treatment of acute hypersensitivity reactions, treatment of nausea / vomiting or chronic treatment (initiated > 6 months prior to study entry) at low dose (< 20 mg methylprednisolone or equivalent)
- •8. Known hypersensitivity against taxanes and/or Epirubicin and/or Fluorouracil/Capecitabine and/or trastuzumab.
- •9. Known deficit of dihydropyrimidine-dehydrogenase (DPD)
- •10. Treatment with an investigational drug within 30 days prior to study entry.
- •11. Legally incapacitated and/or other circumstances which make it undesirable for the subject to understand the nature, meaning and consequences of the clinical study.
- •12. Concurrent psychiatric illness according to ICD (alcohol addiction) at the time of study entry.
- •13. Patients with New Yourk Heart Association (NYHA) class = II heart disease.
- •14. HER-2 positive Patients with a left ventricular ejection fraction (LVEF) of <55% by echocardiography or Muga Scan.
- •15. Serious uncontrolled infections (bacterial odr viral) or poorly controlled diabetes mellitus.
- •16. Positive infraclavicular or supraclavicular lymph node.
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