EUCTR2006-000864-94-SI进行中（未招募）不适用
A phase I-II study of lapatinib and docetaxel as neoadjuvant treatment for HER-2 positive locally advanced/inflammatory or large operable breast cancer. - Lapatax
European Organisation for Research and Treatment of Cancer (EORTC)0 个研究点目标入组 180 人开始时间: 2011年8月9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
- 180
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
- •Breast cancer population for Phase II part
- •* Female patients with any large operable T2 or T3 breast cancers, M0
- •* Or female patients with locally advanced or inflammatory breast cancer 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)
- •- any clinical T, N2 or N3 (ipsilateral supraclavicular nodes)
- •* Presence of bilateral breast cancer, provided only 1 side is HER2 positive
- •* 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 10exp9/L and platelets > 100 x 10exp9/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:
- •- 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
- •* 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 of the protocol)
- •* 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) from 2 weeks before your first study treatment until 4 weeks after your final study treatment.
- •* Patients able to swallow and retain oral medication
- •* Patients may not receive any non-protocol anticancer therapy, or other investigational agents while on study
- •* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •* Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
- •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
- •Exclusion criteria for Phase II part:
- •* Prior history of malignancies except:
- •- basal cell or squamous cell carcinoma of the skin
- •- carcinoma in situ of the cervix
- •- the patient has been free of any other malignancies for > 3 years.
- •* Current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones or stable chronic liver disease not requiring therapy as per investigator assessment)
- •* Clinical signs of CNS involvement
- •* Patients with active or uncontrolled infections or with serious illnesses, malabsorption syndrome or medical conditions, including patients with a history of chronic alcohol abuse, hepatitis, HIV and/or cirrhosis
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