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ISRCTN
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ISRCTN48254013
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ClinicalTrials.gov identifier
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Public title
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A phase III multicentre double blind randomised trial of celecoxib versus placebo in primary breast cancer patients
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Scientific title
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Acronym
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REACT
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Serial number at source
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ICCG C/20/01, GBG 27, BIG 1- 03
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Study hypothesis
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The primary aim is to assess the disease-free survival benefit of two years adjuvant therapy with the cyclooxygensase-2 (COX-2) inhibitor celecoxib compared with placebo in primary breast cancer patients.
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Lay summary
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http://www.cancerhelp.org.uk/trials/a-trial-looking-at-celecoxib-for-women-with-breast-cancer
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Ethics approval
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Approved by the Medical Research Ethics Committee on 19/12/05.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Breast cancer
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Participants - inclusion criteria
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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)
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Participants - exclusion criteria
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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
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Anticipated start date
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01/03/2006
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Anticipated end date
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01/03/2016
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Status of trial
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Ongoing |
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Patient information material
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Target number of participants
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2590
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Interventions
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Interventions criteria has been amended as of 19th December 2005:
Arm A: placebo twice daily for a total of two years
Arm B: 400 mg celecoxib once daily for a total of two years
1. Randomisation is 2:1 in favour of arm B
2. All ER+ and/or Progesterone Receptor positive (PgR+) patients will also receive tamoxifen (20 mg daily) for two to three years followed by exemestane (25 mg daily) for a further two to three years (total endocrine treatment should be for a duration of five years)
Previous interventions criteria:
Arm A: placebo twice daily for a total of two years
Arm B: 400 mg celecoxib twice daily for a total of two years
1. Randomisation is 2:1 in favour of arm B
2. All ER+ and/or PgR+ (Progesterone Receptor) patients will also receive exemestane 25 mg daily for a duration of five years
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Primary outcome measure(s)
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To assess Disease Free Survival (DFS) benefit of two years adjuvant therapy with celecoxib compared with placebo in primary breast cancer patients
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Secondary outcome measure(s)
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Overall survival, toxicity associated with long-term use of celecoxib in primary breast cancer patients, cardiovascular mortality and incidence of second primaries
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Sources of funding
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Pfizer Inc. (UK)
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Trial website
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Publications
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Contact name
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Prof
R. Charles
Coombes
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Address
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Imperial College of Science, Technology and Medicine
Charing Cross Hospital
Fulham Palace road
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City/town
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London
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Zip/Postcode
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W6 8RF
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Country
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United Kingdom
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Sponsor
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Imperial College of Science and Technology (UK)
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Address
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Exhibition Road
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City/town
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London
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Zip/Postcode
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SW7 2AZ
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Country
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United Kingdom
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Date applied
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12/01/2004
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Last edited
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02/08/2011
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Date ISRCTN assigned
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25/02/2004
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