Early breast cancer Cancer Breast cancer
Conditions
Interventions
Subjects will be randomised (1:1:1:1) to receive either:
1. Exemestane + celecoxib (these patients will receive exemestane 25 mg, one tablet daily and celecoxib 400 mg, one tablet twic
Sponsors
University Hospital Birmingham NHS Foundation Trust (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Biopsy proven 2. ER positive invasive breast cancer (where ER positive is defined as equivalent to an ER Quick or Allred score of 3 or greater) 3. Tumour, measured on clinical examination, as greater than 2 cm in diameter 4. Postmenopausal 5. Adequate haematological, renal and liver function, defined as: platelets of greater than 100 x 10(9)/l, white blood cell count of greater than 3 x 10(9)/l, creatinine less than 110 mmol/l, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) less than 1.25 x upper limit of normal 6. Patients must be fit to complete surgery for their breast cancer 7. Written informed consent 8. Eastern Cooperative Oncology Group (ECOG) performance status 0,1 or 2
Exclusion criteria
Exclusion criteria: 1. Bilateral breast cancer 2. Evidence of distant metastases (M1) 3. Patients who have received previous treatment for breast cancer 4. Concomitant active malignancy except for adequately treated carcinoma in situ of the uterine cervix or basal cell carcinoma of the skin 5. Co-morbid disease which would preclude safe surgical treatment of the primary cancer 6. Other physical or psychiatric disorder that may interfere with subject compliance, adequate informed consent or determine the causality of adverse events 7. Contraindications to celecoxib: active peptic ulcer disease, renal impairment, asthma exacerbated by non steroidal anti-inflammatory drugs (NSAIDs), congestive cardiac failure (New York Heart Association [NYHA II-IV]), ischaemic heart disease, cerebrovascular disease, uncontrolled hypertension 8. Patients with an ongoing requirement for regular NSAID or COX-2 inhibitor therapy (asprin 75 mg daily is permitted) 9. Regular selective COX-2 inhibitor use in the two years prior to randomisation 10. History of hypersensitivity to celecoxib, exemestane or letrozole or to any of the excipients 11. Known hypersensitivity to sulphonamides 12. Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 inhibitors 13. Inflammatory bowel disease 14. Patients with ongoing requirements for fluconazole or ketoconazole therapy 15. Patients with ongoing requirement for lithium therapy 16. Patients with ongoing requirement for angiotensin-converting enzyme (ACE) inhibitor therapy 17. Patients who are anticoagulated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective clinical response (complete response [CR], partial response [PR]) to neoadjuvant treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Objective ultrasound-determined response (CR, PR) to neoadjuvant treatment 2. Type of surgery 3. Axillary lymph node involvement at surgery 4. Complete pathological response 5. Local recurrence-free survival 6. Progression-free survival 7. Overall survival For translational sub-study: biological profiling for prognostic and predictive indicators | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed