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 in this arm will receive 2 tablets once daily. In addition Hormone Receptor (+) patients will receive endocrine treatment according to local practice.

Patients in this arm will receive 400mg of celecoxib once daily. In addition, Hormone Receptor (+) patients will receive endocrine treatment according to local practice.
Celecoxib: 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.

Celecoxib

Patients in this arm will receive 2 tablets once daily. In addition Hormone Receptor (+) patients will receive endocrine treatment according to local practice.
Placebo: Two capsules once daily with food

Placebo

Total

Sex: Female, Male

Race/Ethnicity, Customized

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)

Disease Free Survival (DFS) Benefit of Two Years Adjuvant Therapy With the COX-2 Inhibitor Celecoxib Compared With Placebo in Primary Breast Cancer Patients.

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.

Overall Survival

Any malignant contralateral breast disease will be included and recorded as a second primary

Number of Participants With Incidence of Second Primary Breast Cancers

Number of deaths recorded as having cardiovascular involvement are reported by treatment group.

Cardiovascular Mortality

Overall Study

Prof Charles Coombes

Breast Cancer

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.

REACT Trial Information linked to the sponsor webpage

European Celecoxib Trial in Primary Breast Cancer

A Phase III Multicentre Double Blind Randomised Trial of Celecoxib Versus Placebo in Primary Breast Cancer Patients

Imperial College London

Institute of Cancer Research, United Kingdom

Nimesulide 100 mg (capsules), 100mg/die every day for 1 year. Oral administration

Simvastatin 20 mg (capsules). 20mg/die every day for 1 year. Oral administration

Placebo (capsules). 1 cps/die every day for 1 year. Oral administration

Nimesulide 100 mg (capsules). 100mg/die every day for 1 year. Oral administration

nimesulide

Simvastatin

European Institute of Oncology

A Prevention Trial in Subjects at High Risk for Breast Cancer

A Randomized Phase II Prevention Trial in Subjects at High Risk for Hormone Non-responsive Breast Cancer

changes of cellular proliferation marker Ki-67 in blood, ductal lavage fluid at the end of treatment withe respect to baseline. A further assessment will be done at the end of a furter 12 months follow-up.

change in plasma IGF-I, IGFBP-1-2-3, estradiol, estrone sulphate, DHEA-sulphate, SHBG, C-reactive protein, prolactin at the end of treatment

Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.

Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.

Arm I

Arm II

Region of Enrollment

The primary outcome measure is change in mammographic density. The null hypothesis is that there is no difference between the arms in change in mammographic density over one year versus the alternative that the treatment arm reduces mammographic density by 10 points (percent of pixels highlighted) or more over one year compared to the change in the placebo arm.

Mammographic Density

The difference between the two arms in the percent of patients with non-zero ki-67 expression over the two time periods (baseline and 1-year).

oxygenase/càncer de mama

European Celecoxib Trial in Primary Breast Cancer

A Prevention Trial in Subjects at High Risk for Breast Cancer

S0300, Celecoxib in Preventing Breast Cancer in Premenopausal Women

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