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

Phase 3

Completed

• Conditions: Cancer; Breast cancer

• Registration Number: ISRCTN48254013
• Lead Sponsor: Imperial College of Science and Technology (UK)

Brief Summary

2009 Abstract results in https://www.thebreastonline.com/article/S0960-9776(09)70179-1/fulltext conference abstract: 2011 Abstract results in http://ascopubs.org/doi/abs/10.1200/jco.2011.29.15_suppl.tps115 conference abstract: 2018 Abstract results in https://doi.org/10.1158/1538-7445.SABCS17-GS3-03 results in conference abstract: 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34264305/ (added 16/07/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-02-25
• Study Completion: 2016-03-01
• Last Update Posted: 4 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 2639

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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