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English Summary - REACT

Current Status:

United Kingdom: open for accrual

Germany: open for accrual

Randomised Europe An Celecoxib Trial A phase III multicentre double blind randomised trial of Celexocib versus placebo in primary breast cancer patients

Trial design

Multicentre, randomised double-blind, placebo-controlled phase III trial

Treatment

Patients are randomised between two years celecoxib and placebo in a 2:1 ratio in favour of celecoxib (400mg once daily for a total of 2 years).

Additionally all ER+ve and/or PgR+ve patients will receive endocrine therapy according to local practice. Total endocrine therapy should be for a duration of 5 years.

Patient population

Eligibility Criteria

Primary Objective

To assess the disease free survival (DFS) benefit of two years adjuvant therapy with the COX-2 inhibitor celecoxib compared with placebo in primary breast cancer patients.

Secondary Objectives

1. To compare overall survival
2. To define the safety of adjuvant therapy with celecoxib in this patient population
3. To compare incidence of second primary cancers
4. In postmenopausal hormone receptor (HR) positive patients, to assess tolerability of celecoxib with tamoxifen
5. To assess DFS benefit of two years adjuvant celecoxib compared with placebo in HR positive (i.e. ER positive and/or PR positive) and in HR negative (i.e. ER negative/PR negative) disease

Tertiary objectives

To investigate COX2 level and other tumour associated proteins in the tumour tissue and relate these findings to trial outcome.

Primary Endpoint

Disease-free survival

Study Background

The REACT study aims to investigate the potential role of the COX-2 inhibitor celecoxib as adjuvant treatment . The trial was started in 2004, but recruitment was stopped immediately as rofecoxib (Vioxx®) was taken from the market due to potential cardiac toxicity.

In order to re-start the trial considering the current state of knowledge regarding COX-2 inhibitors, the REACT protocol has been revised concerning the following issues.

The medication dose of celecoxib has been reduced from 800 mg daily to 400 mg daily. Patients with previous cardiovascular disease or cardiovascular risk factors are excluded from the trial. Current cardiovascular assessment includes ECG, cardiac history, blood pressure, collection of cholesterol, and information on smoking status. Information obtained from the clinical cardiovascular assessment will be used by the Coordinating Data Centre to calculate the cardiovascular risk of each patient, using the Framingham Risk Equation. Furthermore, any patient who is found to have developed new Q-waves, indicative of myocardial infarction on routine ECG, will be excluded from the celecoxib/ placebo treatment immediately.

All ER+ve and/or PgR+ve patients will receive endocrine therapy according to local practice. Total endocrine therapy should be for a duration of 5 years.

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• Study Group: International Collaborative Cancer Group (ICCG), German Breast Group (GBG)
• For more information: Imperial Clinical Trials
• International Study Chair: Prof. Dr. R. C. Coombes
• German Study Chair: Prof. Dr. Gunter von Minckwitz
• Clinical Project Management: Dr. Kai Büchsenschütz
• Data Management / Biometry: Dr. Valentina Nekljudova
• Study start: Q-III 2008 (in Germany)
• Proposed accrual: 2590

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