Condition category
Cancer
Date applied
12/01/2004
Date assigned
25/02/2004
Last edited
02/08/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof R. Charles Coombes

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ICCG C/20/01, GBG 27, BIG 1- 03

Study information

Scientific title

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

Approved by the Medical Research Ethics Committee on 19/12/05.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Phase

Phase III

Drug names

1. Celecoxib
2. Tamoxifen
3. Exemestane

Primary outcome measures

To assess 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 trial start date

01/03/2006

Overall trial end date

01/03/2016

Reason abandoned

The old trial was stopped because the EMEA was to carry out a sixmonth review of all the data they had for COX-2 inhibitors following the time when VIOXX was taken off the market

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

2590

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

United Kingdom

Trial participating centre

Imperial College of Science, Technology and Medicine
London
W6 8RF
United Kingdom

Sponsor information

Organisation

Imperial College of Science and Technology (UK)

Sponsor details

Exhibition Road
London
SW7 2AZ
United Kingdom

Sponsor type

Research organisation

Website

Funders

Funder type

Industry

Funder name

Pfizer Inc. (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes