eoadjuvant trial of pre-operative exemestane or letrozole +/-celecoxib in the treatment of ER positive postmenopausal early breast cancer. - NEO-EXCE

• Conditions: Postmenopausal early breast cancer; MedDRA version: 16.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2006-000436-27-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-07
• Last Update Posted: 30 September 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 256

Inclusion Criteria

The study population consists of postmenopausal women diagnosed with resectable breast cancer, who meet the following eligibility criteria:
-Biopsy proven, ER positive invasive breast cancer (where ER positive is defined as equivalent to an ER Quick or Allred score” of 3 or greater).
-Tumour, measured on ultrasound, as greater than or equal to 2 cm in diameter.
-Postmenopausal defined as:
Any Age:- bilateral surgical oophorectomy
amenorrhea ? 5 years (any cause)

Age ? 50 yrs:-natural amenorrhea for ? 1 year

Age <50 yrs: -if amenorrhea < 5 years or hysterectomy without
bilateral surgical oophorectomy, then FSH, and/or LH and/or
oestradiol must be assayed to confirm postmenospausal status

-Adequate haematological, renal and liver function, defined as a platelets of >100 x 109/l, white blood cell count of >3 x 109/l, creatinine <110 mmol/l, AST and/or ALT < 1.25 x upper limit of normal
-Patients must be fit to complete surgery for their breast cancer
-Written informed consent
- ECOG performance status 0,1 or 2

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Bilateral breast cancer.
-Evidence of distant metastases (M1).
-Patients who have received previous treatment for invasive breast cancer.
-Concomitant active malignancy.
-Co-morbid disease which would preclude safe surgical treatment of the primary cancer.
- Other physical or psychiatric disorder that may interfere with subject compliance, adequate informed consent or determine the causality of adverse events.
- Contraindications to celecoxib: active peptic ulcer disease, renal impairment, asthma exacerbated by NSAIDS, congestive cardiac failure (NYHAII-IV*), ischaemic heart disease, cerebrovascular disease, uncontrolled hypertension.
-Patients with an ongoing requirement for regular NSAID or COX2 inhibitor therapy (Asprin 75mg daily is permitted).
-Regular selective COX 2 inhibitor use in the 2 years prior to randomisation
-History of hypersensitivity to celecoxib, exemestane or letrozole or to any of the excipients (see section 6.1).
-Known hypersensitivity to sulphonamides.
-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.
-Inflammatory bowel disease.
-Patients with ongoing requirements for fluconazole or ketoconazole therapy.
-Patients with ongoing requirement for lithium therapy.
-Patients with ongoing requirement for ACE inhibitor therapy.
-Patients who are on warfarin or heparin .

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether the addition of a COX2 inhibitor to an aromatase inhibitor results in greater objective clinical response, with acceptable toxicity, than an aromatase inhibitor alone. <br>Primary endpoint is objective clinical response (Complete Response, Partial Response) during neoadjuvant treatment.<br>;Secondary Objective: Secondary endpoints include:<br><br>-Objective ultrasound-determined response (Complete Response, Partial Response) during neoadjuvant treatment<br>-Type of surgery<br>-Axillary lymph node involvement at surgery<br>-Biological profiling for prognostic and predictive indictors<br>-Local recurrence<br>-Progression-free survival<br>-Overall survival<br>;Primary end point(s): Primary endpoint is objective clinical response (Complete Response, Partial Response) during neoadjuvant treatment.<br>