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

ISRCTN	ISRCTN48254013
DOI	https://doi.org/10.1186/ISRCTN48254013
ClinicalTrials.gov number	NCT02429427
Secondary identifying numbers	ICCG C/20/01, GBG 27, BIG 1- 03

Submission date: 12/01/2004
Registration date: 25/02/2004
Last edited: 23/09/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

http://www.cancerhelp.org.uk/trials/a-trial-looking-at-celecoxib-for-women-with-breast-cancer

Contact information

Prof R. Charles Coombes
Scientific

Imperial College of Science, Technology and Medicine
Charing Cross Hospital
Fulham Palace road
London
W6 8RF
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	A phase III multicentre double blind randomised trial of celecoxib versus placebo in primary breast cancer patients
Study acronym	REACT
Study hypothesis	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.
Ethics approval(s)	Approved by the Medical Research Ethics Committee on 19/12/2005
Condition	Breast cancer
Intervention	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
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	1. Celecoxib 2. Tamoxifen 3. Exemestane
Primary outcome measure	Disease Free Survival (DFS) benefit of two years adjuvant therapy with celecoxib compared with placebo in primary breast cancer patients
Secondary outcome measures	Overall survival, toxicity associated with long-term use of celecoxib in primary breast cancer patients, cardiovascular mortality and incidence of second primaries
Overall study start date	01/03/2006
Overall study end date	01/03/2016
Reason abandoned (if study stopped)	The old trial was stopped because the EMEA was to carry out a six month review of all the data they had for COX-2 inhibitors following the time when VIOXX was taken off the market

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	2590
Total final enrolment	2639
Participant 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)
Participant 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
Recruitment start date	01/03/2006
Recruitment end date	01/03/2016

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Imperial College of Science, Technology and Medicine

London
W6 8RF
United Kingdom

Sponsor information

Imperial College of Science and Technology (UK)
Research organisation

Exhibition Road
London
SW7 2AZ
United Kingdom

"ROR"	https://ror.org/041kmwe10

Funders

Funder type

Industry

Pfizer UK
Private sector organisation / For-profit companies (industry)

Alternative name(s): Pfizer Ltd, Pfizer Limited
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results	conference abstract:	01/03/2009		No	No
Abstract results	conference abstract:	20/05/2011		No	No
Abstract results	results in conference abstract:	15/02/2018		No	No
Results article		15/07/2021	16/07/2021	Yes	No

Editorial Notes

23/09/2021: Cancer Research UK lay results summary link added to Results (plain English).
16/07/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
14/05/2018: Publication references added.