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 (NCT) | NCT02429427 |
| Protocol serial number | ICCG C/20/01, GBG 27, BIG 1- 03 |
| Sponsor | Imperial College of Science and Technology (UK) |
| Funder | Pfizer UK |
- 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 of protocol
http://www.cancerhelp.org.uk/trials/a-trial-looking-at-celecoxib-for-women-with-breast-cancer
Contact information
Prof R. Charles Coombes
Scientific
Scientific
Imperial College of Science, Technology and Medicine
Charing Cross Hospital
Fulham Palace road
London
W6 8RF
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | 1. Celecoxib 2. Tamoxifen 3. Exemestane |
| Primary outcome measure(s) | Disease Free Survival (DFS) benefit of two years adjuvant therapy with celecoxib compared with placebo in primary breast cancer patients |
| Key secondary outcome measure(s) | Overall survival, toxicity associated with long-term use of celecoxib in primary breast cancer patients, cardiovascular mortality and incidence of second primaries |
| Completion 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 sample size at registration | 2590 |
| Total final enrolment | 2639 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/03/2006 |
| Date of final enrolment | 01/03/2016 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Imperial College of Science, Technology and Medicine
London
W6 8RF
United Kingdom
W6 8RF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 15/07/2021 | 16/07/2021 | Yes | No | |
| 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
