EUCTR2008-005466-30-GB进行中（未招募）不适用
Effect of Perioperative AntiHER2 Therapy on Early Breast Cancer Study - Biological Phase - EPHOS-B
niversity of Manchester0 个研究点目标入组 250 人开始时间: 2010年3月15日最近更新:
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
- 250
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
- •Women aged =18 years.
- •HER2 positive (3+ on IHC or amplification proven by FISH*) operable invasive breast cancer diagnosed by core biopsy.
- •Planned surgery within one month of diagnosis.
- •Serum creatinine and bilirubin <2 times the upper limits of normal for the institution, or creatinine clearance >30mg/dL. (Marginally abnormal test results should be repeated).
- •ECOG performance status 0, 1, or 2 (Karnofsky = 60%).
- •Non pregnant and non-lactating with no intention of pregnancy during study treatment. Women of childbearing potential must agree to use adequate non-hormonal contraception for the duration of the treatment phase of the study (adequate contraceptive measures include intra-uterine device, barrier method e.g. diaphragm and condoms used in conjunction with spermicidal jelly). Women of childbearing potential must have a negative blood serum pregnancy test within 28 days prior to randomisation).
- •Patients must be candidates for and willing to undergo adjuvant chemotherapy and trastuzumab post surgery.
- •Written informed consent obtained for trial and to donation of tissue and blood samples.
- •* Details of how FISH cases should be categorised are included the protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •HER2 negative cancers and those with unknown HER2 status.
- •Inoperable breast cancer (T4 category) or suspicion of distant metastases.
- •Diagnosis of inflammatory breast cancer.
- •Clinical evidence of metastatic disease.
- •Prior herceptin therapy within the last 12 months or local (radiotherapy) cancer treatments.
- •Previous cancer at any other site that has been treated within the last 6 months (except previous basal cell carcinoma and cervical carcinoma in situ)
- •Have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones or stable chronic liver disease per investigator assessment).
- •Impaired gastro-intestinal function thought sufficient to reduce lapatinib absorption.
- •Contra-indicated to receive adjuvant chemotherapy and /or trastuzumab (ECOG >2).
- •Known immediate or delayed hypersensitivity, reaction to drugs chemically related to trastuzumab or lapatinib.
- •Other concomitant investigational agents or concurrent anti-cancer therapy.
- •Use of herbal (alternative) therapies within 2 weeks of study entry.
- •(NB vitamin and / or mineral supplements are allowed).See Appendix 1 of the protocol.
- •If patients are taking any of the prohibited medication as listed in Appendix 1 of the protocol.
- •Regular use of systemic steroids or other agents that could influence study endpoints (inhaled steroids are allowed).
- •Any altered mental state that would preclude obtaining written informed consent.
- •Clinically significant cardiac abnormalities or uncontrolled hypertension.
- •Previous myocardial infarction, heart failure, or significant angina. Cardiac function should be assessed by physical examination, ECG, and baseline LVEF should be =55% as measured by echocardiography or MUGA.
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