ISRCTN48254013
Completed
Phase 3
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 sites2,639 target enrollmentFebruary 25, 2004
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Breast cancer
- Sponsor
- Imperial College of Science and Technology (UK)
- Enrollment
- 2639
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
2009 Abstract results in https://www.thebreastonline.com/article/S0960-9776(09)70179-1/fulltext conference abstract: 2011 Abstract results in http://ascopubs.org/doi/abs/10.1200/jco.2011.29.15_suppl.tps115 conference abstract: 2018 Abstract results in https://doi.org/10.1158/1538-7445.SABCS17-GS3-03 results in conference abstract: 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34264305/ (added 16/07/2021)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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