EUCTR2004-004957-24-ES进行中（未招募）不适用
European Cooperative Study of Primary Systemic Therapyin Women with Operable Breast Cancer and T > 2 cmEstudio Cooperativo Europeo de Terapia Sistémica Primaria en Mujeres con Cáncer de Mama Operable y T > 2cm - ECTO II
Fondazione Michelangelo0 个研究点目标入组 486 人开始时间: 2005年10月24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
- 入组人数
- 486
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, presenting for the first time with unilateral operable breast cancer > 2.0 cm in largest diameter, who have not received any previous treatment for an invasive malignancy
- •2. Histologically proven diagnosis of invasive breast cancer
- •3. Estrogen receptor status assessed as negative (Study 1) or positive (Study 2)
- •4. Age >= 18 years
- •5. ECOG Performance Status =< 1
- •6. Availability of HER2 status on immunohistochemistry
- •7. Availability of progesterone receptor status
- •8. Primary tumor lesion measurable on largest diameter by clinical and/or radiological examination. Presence of suspected multifocal disease does not exclude the patient
- •9. Patients must have completed all instrumental and laboratory evaluations within 4 weeks prior to study entry
- •10. Signed written informed consent (approved by the Institutional Review Board [IRB]/ Independent Ethics Committee [IEC]) obtained prior to any study specific screening procedures.
- •11. Able to comply with the protocol.
- •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
- •1. Pregnant or lactating women. Documentation of a negative pregnancy test must be available for premenopausal women with intact reproductive organs and for women less than one year after the menopause
- •2. Women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception. For example: intra-uterine device or barrier method of contraception in conjunction with spermicidal jelly
- •3. Evidence of metastases or locally advanced breast cancer
- •4. Bilateral breast cancer
- •5. Absence of ER assessment
- •6. Previous treatment with chemotherapy or hormonal therapy or any prior therapy with any investigational drug for any type of malignancy
- •7. Previous extensive radiotherapy or major surgery for any malignancy
- •8. Previous or concomitant malignancy of any type, except adequately treated basal cell carcinoma of the skin or in situ cervix cancer
- •9. Patients with New York Heart Association (NYHA) class >= II heart disease.
- •10. Patients with a left ventricular ejection fraction (LVEF) below 50% by MUGA scan or echocardiography
- •11. Pre-existing motor or sensory neuropathy of grade > 1 for any reason
- •12. Patients with a history of hypersensitivity due to administration of drugs containing polyoxyethylene castor oil (Cremophor EL) (e.g., cyclosporin), or hardened castor oil (e.g., vitamin preparations for injection, etc.)
- •13. Other serious illness or medical condition including: history of documented congestive cardiac failure; angina pectoris requiring antianginal medication; evidence of transmural infarction on ECG; poorly controlled hypertension (e.g. systolic > 180 mm Hg or diastolic >100 mm Hg; however, patients with hypertension which is well controlled on medication are eligible); clinically significant valvular heart disease; high-risk uncontrolled arrhythmias
- •14. Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and precluding informed consent or adversely affecting compliance to study drugs
- •15.Serious uncontrolled infections (bacterial or viral) or poorly controlled diabetes mellitus
- •16. Any of the following abnormal baseline hematological values: neutrophils < 1,500, platelets < 100,000
- •17. Any of the following abnormal laboratory tests: serum total bilirubin > 1.25 x ULN (upper limit of normal) (except for patients with clearly documented Gilbert’s syndrome), alanine transaminase (ALT) or aspartate transaminase (AST) > 1.25 x ULN, alkaline phosphatase > 1.25 x ULN, serum creatinine > 1.5 x ULN
研究者
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