A phase III multicentre double blind randomised trial of celecoxib versus placebo in primary breast cancer patients

Conditions

Breast cancer Cancer Breast cancer

R. Charles Coombes, Holly Tovey, Lucy Kilburn, Janine Mansi, Carlo Palmieri et al. (100 authors)

JAMA Oncology2021-07-1542 citations

10.1001/jamaoncol.2021.2193

Celecoxib plus hormone therapy versus hormone therapy alone for hormone-sensitive prostate cancer: first results from the STAMPEDE multiarm, multistage, randomised controlled trial.

James ND, Sydes MR, Mason MD, Clarke NW, Anderson J, Dearnaley DP, Dwyer J, Jovic G, Ritchie AW, Russell JM, Sanders K, Thalmann GN, Bertelli G, Birtle AJ, O'Sullivan JM, Protheroe A, Sheehan D, Srihari N, Parmar MK, STAMPEDE investigators.

2012-03-2686 citations

10.1016/s1470-2045(12)70088-8

Interventions

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

Eligibility

Sex/Gender

Female

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Secondary

Measure	Time frame
Overall survival, toxicity associated with long-term use of celecoxib in primary breast cancer patients, cardiovascular mortality and incidence of second primaries	—

Primary

Measure	Time frame
Disease Free Survival (DFS) benefit of two years adjuvant therapy with celecoxib compared with placebo in primary breast cancer patients	—

Countries

England, United Kingdom

Outcome results

None listed