ISRCTN15004993已完成3 期
Effect of peri-operative anti-HER2 therapy on early breast cancer: a randomised phase III open-label multicentre clinical trial
niversity of Manchester (UK)0 个研究点目标入组 257 人开始时间: 2009年3月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 257
研究概览
简要总结
2016 Abstract results see attached file 18515 Abstract EBBC March 2016-EPHOS-B session.pdf (added 09/03/2023) 2021 Poster results see attached file 18515 Poster 07.12.21 EPHOS-B SABCS 2021 v2.pdf [2] (added 09/03/2023) 2022 Results article in https://doi.org/10.1158/1078-0432.CCR-21-3177 (added 09/03/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Women aged greater than or equal to 18 years old
- •2. HER2 (3+ on immunohistochemistry [IHC] or amplification proven by fluorescent in-situ hybridisation [FISH]) positive operable invasive breast cancer diagnosed by core biopsy
- •3. Planned surgery within one month of diagnosis
- •4. Serum creatinine and bilirubin less than 2 times the upper limits of normal for the institution, or creatinine clearance greater than 30 mg/dL (Marginally
- •abnormal test results should be repeated)
- •5. Eastern Cooperative Oncology Group (ECOG) performance status 0,1, or 2 (Karnofsky greater than or equal to 60%)
- •6. Non-pregnant and non-lactating with no intention of pregnancy during study treatment
- •7. Written informed consent obtained for trial and to donation of tissue and blood samples
- •Added 19/02/10:
- •8. Patients must be candidates for and willing to undergo adjuvant chemotherapy and trastuzumab post surgery
排除标准
- •Current information as of 19/02/10:
- •1. HER2 negative cancers and those with unknown HER2 status
- •2. Inoperable breast cancer (T4 category) or suspicion of distant metastases
- •3. Diagnosis of inflammatory breast cancer
- •4. Clinical evidence of metastatic disease
- •5. Prior herceptin therapy within the last 3 months or local (radiotherapy) cancer treatments
- •6. 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)
- •7. Have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
- •8. Impaired gastro-intestinal function thought sufficient to reduce lapatinib absorption
- •9. Contra-indicated to receive adjuvant chemotherapy and/or trastuzumab (ECOG >2)
- •10. Known immediate or delayed hypersensitivity, reaction to drugs chemically related to trastuzumab or lapatinib
- •11. Other concomitant investigational agents or concurrent anti-cancer therapy
- •12. Regular use of systemic steroids or other agents that could influence study endpoints (inhaled steroids are allowed)
- •13. Any altered mental state that would preclude obtaining written informed consent
- •14. Patients who have clinically significant cardiac abnormalities or uncontrolled hypertension
- •15. 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.
- •Initial information at time of registration:
- •1. HER2 negative cancers and those with unknown HER2 status
- •2. Inoperable breast cancer (T4 category) or suspicion of distant metastases
- •3. Diagnosis of inflammatory breast cancer
- •4. Clinical evidence of metastatic disease
- •5. No prior systemic (i.e. chemotherapy) or local (radiotherapy) cancer treatments
- •6. Previous cancer at any other site (except previous basal cell carcinoma and cervical carcinoma in situ)
- •7. Abnormal renal function
- •8. Abnormal liver function tests
- •9. Have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
- •10. Impaired gastro-intestinal function thought sufficient to reduce lapatinib absorption
- •11. Contra-indication to receive adjuvant chemotherapy and/or trastuzumab (ECOG greater than 2)
- •12. Known immediate or delayed hypersensitivity, reaction to drugs chemically related to trastuzumab or lapatinib
- •13. Other concomitant investigational agents or concurrent anti-cancer therapy. In addition all herbal (alternative) therapies are prohibited.
- •14. Regular use of systemic steroids or other agents that could influence study endpoints
- •15. Patient must not have clinically significant cardiac abnormalities or uncontrolled hypertension
- •16. No previous myocardial infarction, heart failure, or significant angina. Cardiac function should be assessed by physical examination, electrocardiogram (ECG), and baseline left ventricular ejection fraction (LVEF) should be greater than or equal to 50% as measured by echocardiography or multiple-gated acquisition (MUGA) scan.
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