European Celecoxib Trial in Primary Breast Cancer (REACT)
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|ClinicalTrials.gov Identifier: NCT02429427|
Recruitment Status : Completed
First Posted : April 29, 2015
Last Update Posted : July 15, 2019
It has been found that the chemical changes that take place in a patient's body during the development of inflammation may provide an environment which stimulates cancer cells. One step in the development of inflammation is the production of certain chemical substances which are important in the formation and spread of tumours. These are called prostaglandins. Cyclo-oxygenase II (COX-2) is an enzyme (a substance that speeds up chemical changes in the body) involved in the production of these prostaglandins and although it is not usually present in most tissues it is made at the sites of inflammation. Celecoxib is a selective Non-Steroidal Anti Inflammatory Drug (NSAID) which works by blocking the action of the COX-2 enzyme, leading to a decrease in the production of prostaglandins and a reduction in inflammation.
The purpose of this study is therefore to find out if celecoxib can be used after breast cancer treatment (chemotherapy and/ or radiotherapy) to reduce inflammation and thus reduce the ability of new tumours to grow and survive.
2590 women with primary breast cancer will be recruited in this study from several locations in the United Kingdom and Germany. Eligible patients will be randomly allocated a treatment group, which can be celecoxib or placebo. Both treatments are taken orally (celecoxib 400mg daily, placebo 2 tablets daily) for a total of 2 years. In addition, hormone receptor positive patients will receive endocrine treatment as per local practice. Patients will prematurely discontinue treatment with celecoxib/placebo if disease progression is confirmed or if patients experience unacceptable toxicity.
Patients will be seen every 6 months for the first 3 years and then off treatment follow-up is carried out annually. Participating patients will also be given the option to take part in the pathology sub-study by donating a sample of the tumour tissue collected at the time of the primary surgery.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Celecoxib Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2639 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Phase III Multicentre Double Blind Randomised Trial of Celecoxib Versus Placebo in Primary Breast Cancer Patients|
|Actual Study Start Date :||December 2005|
|Actual Primary Completion Date :||March 2019|
|Actual Study Completion Date :||March 2019|
Patients in this arm will receive 400mg of celecoxib once daily. In addition, Hormone Receptor (+) patients will receive endocrine treatment according to local practice.
Patients will receive 400mg of Celecoxib once daily for two years or until disease progression (if before the two years limit) or until development of unacceptable toxicities. In addition ER(+) patients will receive endocrine treatment according to local practice.
Other Name: Celebrex, Onsenal, Celebra
Placebo Comparator: Placebo
Patients in this arm will receive 2 tablets once daily. In addition Hormone Receptor (+) patients will receive endocrine treatment according to local practice.
Two capsules once daily with food
- Disease free survival (DFS) benefit of two years adjuvant therapy with the COX-2 inhibitor celecoxib compared with placebo in primary breast cancer patients. [ Time Frame: Patients will be assessed at baseline, months 3, 6 and 12 in the first year; at 6 monthly intervals in years 2 and 3; annually thereafter for years 4 to 10. ]From time of randomisation to the date of first event; with events contributing to the analysis defined as loco-regional and distant breast cancer recurrence, new primary breast cancer (ipsilateral or contralateral) and death without disease relapse (intercurrent death)
- Overall survival [ Time Frame: Date of randomisation until the date of death from any cause or censored at the date the patient was last seen alive. Assessed at baseline, months 3, 6 and 12 in the first year; at 6 monthly intervals in years 2 and 3; annually thereafter ]First local recurrence and first distant recurrence will be recorded on separate parts of the CRF. In the event of local progression, all patients must be followed up for distant recurrence, second malignancy and survival. Similarly in the case of second malignancy, the appropriate CRF should be completed and patients should REACT Protocol, Version 39, dated 01.11.2016 Page 34 of 48 continue to be followed for disease progression and where possible the relation of any subsequent disease progression and/or death due to the primary or second cancer should be established.
- Safety of adjuvant therapy with celecoxib in this patient population [ Time Frame: From randomisation until 30 days after completion of treatment with celecoxib/placebo. Patients will be assessed at baseline, months 3, 6 and 12 in the first year; at 6 monthly intervals in year 2. ]Assessed by the collection of adverse events according to the Common Terminology Criteria for Adverse Events
- To compare incidence of second primary breast cancers [ Time Frame: From randomisation until a second primary breast cancer is diagnosed. Patients will be assessed at baseline, months 3, 6 and 12 in the first year; at 6 monthly intervals in years 2 and 3; annually thereafter. ]Any malignant contralateral breast disease will be included and recorded as a second primary
- Cardiovascular mortality [ Time Frame: Cardiovascular assessments are carried out at the 12 month and 24 month time-points after randomisation. A cardiovascular assessment will also be carried out if treatment is stopped early (before the 24 month time-point). ]Clinical cardiovascular assessment undertaken including cardiac history, blood pressure, pulse, results for HDL and total cholesterol, smoking status and diabetes in addition to an ECG assessment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02429427
|Principal Investigator:||Charles R Coombes, MD||Imperial College London|