Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Contact information



Primary contact

Ms Claire Gaunt


Contact details

Cancer Research UK Clinical Trials Unit (CRCTU)
School of Cancer Sciences
University of Birmingham
B15 2TT
United Kingdom
+44 (0)121 4143797

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title



Study hypothesis

The hypotheses to be addressed in this bifactoral phase III trial are that exemestane may be superior to letrozole (the present standard of care), as primary neoadjuvant endocrine therapy for early stage oestrogen receptor (ER)-positive breast cancer in postmenopausal women, and that the activity of aromatase inhibitors in this setting may significantly be enhanced by the addition of the selective cyclooxygenase-2 (COX-2) inhibitor, celecoxib.

Please note, as of 15/02/2011 the trial record has been updated. The anticipated end date has been extended from 01/08/2010 to 01/05/2012 and the target participant number reduced from 1000 to 256.

Ethics approval

West Midlands MREC on 21/07/2006 (ref: 06/MRE07/31).

Study design

Prospective, phase III, multicentre, bifactorial (four-arm), randomised clinical trial, with both open-label and placebo-controlled comparisons

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet


Early breast cancer


Please note that as of 14/05/08 the anticipated start date of this trial was amended to 01/08/2007. The previous anticipated start date was 01/08/2006.

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 twice daily)
2. Exemestane + celecoxib-placebo (these patients will receive exemestane 25 mg, one tablet daily and celecoxib-placebo, one tablet twice daily)
3. Letrozole + celecoxib (these patients will receive letrozole 2.5 mg, one tablet daily and celecoxib 400 mg, one tablet twice daily)
4. Letrozole + celecoxib-placebo (these patients will receive letrozole 2.5 mg, one tablet daily and celecoxib-placebo, one tablet twice daily)
Treatment will continue for 16 weeks until day of surgery.

Intervention type



Phase III

Drug names

Exemestane, letrozole, celecoxib

Primary outcome measures

Objective clinical response (complete response [CR], partial response [PR]) to neoadjuvant treatment.

Secondary outcome measures

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

Overall trial start date


Overall trial end date


Reason abandoned


Participant 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

Participant type


Age group




Target number of participants

Added 15/02/2011: 266 (At time of registration:1000)

Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Cancer Research UK Clinical Trials Unit (CRCTU)
B15 2TT
United Kingdom

Sponsor information


University Hospital Birmingham NHS Foundation Trust (UK)

Sponsor details

c/o University of Birmingham
B15 2TT
United Kingdom

Sponsor type




Funder type


Funder name

Cancer Research UK (CRUK) (UK) - grant

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Pfizer (UK) - educational grant

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes