A phase III multicentre double blind randomised trial of celecoxib versus placebo in primary breast cancer patients

Imperial College of Science and Technology (UK)0 个研究点目标入组 2,639 人开始时间: 2004年2月25日最近更新: 2021年10月4日

适应症

试验速览

•Inclusion criteria amended as of 19th December 2005:
•1. Resected node positive or high-risk node negative breast cancer (St Gallen 2001 criteria)
•2. Postmenopausal or Estrogen Receptor (ER) negative premenopausal
•3. If (neo) adjuvant chemotherapy has been received then at least four cycles should have been completed
•4. Entry into study must be greater than or equal to 28 days after the end of chemotherapy and within 12 weeks of day one of last cycle of adjuvant chemotherapy, or within six weeks of the end of radiotherapy (whichever is last)
•5. Normal baseline Electrocardiogram (ECG) and normal clinical cardiovascular assessment after completion of all (neo) chemotherapy and radiotherapy
•Previous inclusion criteria:
•1. Resected node positive or high risk node negative breast cancer (St Gallen 2001 criteria)
•2. Postmenopausal or ER (Estrogen Receptor) negative premenopausal
•3. Completion of at least four cycles (neo) adjuvant chemotherapy greater than or equal to 28 days after end of chemotherapy and within 12 weeks of day one of last cycle of adjuvant chemotherapy, or within six weeks of end of radiotherapy (whichever is last)

•1.Active or previous peptic ulceration or GastroIntestinal (GI) bleeding in the last year
•2. Known or suspected congestive heart failure (New York Heart Association [NYHA] classification greater than one) and or coronary heart disease, previous Myocardial Infarction (MI), uncontrolled arterial hypertension (i.e. Blood Pressure (BP) greater than 160/90 mmHg under treatment), rhythm abnormalities requiring permanent treatment
•3. Past history of stroke, Transient Ischaemic Attack (TIA) or peripheral vascular disease
•4. C-Erb-B2 +++ or Fluorescent In Situ Hybridisation (FISH) positive

发起方

Imperial College of Science and Technology (UK)