EUCTR2006-000864-94-FR进行中（未招募）1 期
A Phase I-II Study of Lapatinib and docetaxel as neoadjuvant treatment for HER-2 positive locally advanced/inflammatory or large operable breast cancer
European Organisation for Research and Treatment of Cancer0 个研究点目标入组 128 人开始时间: 2006年10月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 128
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
入选标准
- •Female patients with locally advanced or inflammatory breast cancer for whom neo-adjuvant chemotherapy is appropriate defined as:
- •? Clinical T4 a,b,c,d, any N (inflammatory breast carcinoma: tumor mass, breast
- •enlargement, oedema and warmth of the skin are often present but not mandatory
- •for the diagnosis)
- •? Or any clinical T, N2 or N3 (ipsilateral supraclavicular nodes)
- •? Presence of bilateral breast cancer is allowed
- •? Patients with minimal lung, skin, or nodal metastatic disease shall be discussed case-by-case with the study co-ordinators. Patients with bone, liver or other extensive metastases are non eligible
- •? No prior therapy for any cancer, including chemotherapy, radiotherapy, hormonotherapy for
- •breast cancer, EGFR or HER-2 or antibody therapy.
- •? Histologically confirmed diagnosis of invasive breast cancer
- •? Known hormone receptor status: ER/PR positive or negative.
- •? HER-2 positive (IHC 3+, or IHC 2+ and FISH/CISH +, or FISH, or CISH+ only)
- •? Two frozen trucuts with a 14 G needle are mandatory for every core biopsy indicated by the translational research study
- •? Age 18 to 70 years
- •? WHO performance status 0-2
- •? Adequate bone marrow function: hemoglobin > 10.0 g/dl or 6.2 mmol/L, neutrophils > 1.5 x 109/L and platelets > 100 x 109/L
- •? Adequate hepatic and renal function, defined as follows:
- •? Bilirubin < 1.5 x ULN,
- •? AST and/or ALT < 3 x ULN
- •? Serum creatinine < 1.5 x ULN
- •? Patients must be accessible for repeat dosing and follow-up
- •? Clinically normal cardiac function (LVEF assessed by MUGA or ECHO), normal 12 lead ECG, and in the past 6 months no serious cardiac illness or medical condition including but not confined to:
- •EORTC 10054 Phase I-II LAPATAX LABC
- •Version 1.1 22 / 123 26 July, 2006
- •? History of documented congestive heart failure (CHF)
- •? High-risk uncontrolled arrhythmias
- •? Angina pectoris requiring antianginal medication
- •? Clinically significant valvular heart disease
- •? Evidence of transmural infarction on ECG
- •? Poorly controlled hypertension (e.g. systolic >180mm Hg or diastolic greater
- •than 100mm Hg)
- •? Drugs and several HERBAL CONSTITUENTS (e.g. bergamottin and glabridin), which are inducers or inhibitors of CYP3A4 must not be taken within 10 days prior to initiation of treatment and are prohibited while the patient is being treated with Lapatinib (a detailed list is provided in chapter 5)
- •? No clinical signs of CNS involvement
- •? Women should either not be of childbearing potential (having had a hysterectomy, a bilateral oophorectomy or bilateral tubal ligation, or be post-menopausal with a total cessation of menses of > 1 year), or not be pregnant (negative serum pregnancy test at entry); should not be lactating; should agree to use contraceptive methods (with a documented failure rate < 1%, vasectomized partner sterile prior to trial entry and sole sexual partner or double-barrier contraception) while on treatment and during a period of 3 months after the end of treatment.
排除标准
- 未提供
研究者
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