eoadjuvant trial of pre-operative exemestane or letrozole +/- celecoxib in the treatment of oestrogen receptor-positive early breast cancer
- Conditions
- Early breast cancerCancerBreast cancer
- Registration Number
- ISRCTN09768535
- Lead Sponsor
- niversity Hospital Birmingham NHS Foundation Trust (UK)
- Brief Summary
2016 Abstract results in https://doi.org/10.1158/1538-7445.SABCS15-PD2-02 (added 02/03/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 269
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective clinical response (complete response [CR], partial response [PR]) to neoadjuvant treatment
- Secondary Outcome Measures
Name Time Method <br> 1. Objective ultrasound-determined response (CR, PR) to neoadjuvant treatment<br> 2. Type of surgery<br> 3. Axillary lymph node involvement at surgery<br> 4. Complete pathological response<br> 5. Local recurrence-free survival<br> 6. Progression-free survival<br> 7. Overall survival<br> For translational sub-study: biological profiling for prognostic and predictive indicators<br>