ISRCTN96423607已完成不适用
European Cooperative Study of Primary Systemic Therapy in Women with Operable Breast Cancer and T > 2 cm: a multicentre open-labelled trial with two separate parallel studies
Fondazione Michelangelo (Italy)0 个研究点目标入组 486 人开始时间: 2010年4月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
入排标准
- 性别
- Female
入选标准
- •1. Female patients, presenting for the first time with unilateral operable breast cancer larger than 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 greater than or equal to 18 years
- •5. Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 1
- •6. Availability of Human EGF (Epidermal Growth Factor) Receptor 2 (HER2) status on immunohistochemistry
- •7. Availability of progesterone receptor status
- •8. Primary tumour 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
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 greater than or equal to II heart disease
- •10. Patients with a left ventricular ejection fraction (LVEF) below 50% by Multiple Uptake Gated Acquisition (MUGA) scan or echocardiography
- •11. Pre-existing motor or sensory neuropathy of grade greater than 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:
- •13.1. History of documented congestive cardiac failure
- •13.2. Angina pectoris requiring antianginal medication
- •13.3. Evidence of transmural infarction on ECG
- •13.4. Poorly controlled hypertension (e.g. systolic greater than 180 mm Hg or diastolic greater than 100 mm Hg; however, patients with hypertension which is well controlled on medication are eligible)
- •13.5. Clinically significant valvular heart disease
- •13.6. 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 haematological values:
- •16.1. Neutrophils less than 1.5 x10^9/L
- •16.2. Platelets less than 100 x 10^9/L
- •17. Any of the following abnormal laboratory tests:
- •17.1. Serum total bilirubin greater than 1.25 xULN (upper limit of normal) (except for patients with clearly documented Gilbert?s syndrome)
- •17.2. Alanine transaminase (ALT) or aspartate transaminase (AST) greater than 1.25 x ULN
- •17.3. Alkaline phosphatase greater than 1.25 x ULN
- •17.4. Serum creatinine greater than 1.5 x ULN
研究者
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