Breast cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
The participants will be randomly allocated to the following two arms (randomisation ratio 1:1):
Arm A: Exemestane (Aromasin®) (oral) 25 mg/day for 18 weeks
Arm B: Exemestane (Aromasin®) (oral) 25 mg/
Sponsors
Cambridge University Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Females aged 50 to 80 years old 2. Ultrasound size: greater than 1 cm 3. Diagnosis of invasive breast cancer on core biopsy 4. Patients with localised, locally advanced invasive breast cancer 5. Histological grade: G1-3 6. Oestrogen Receptor (ER) positive (Allred score >=4)
Exclusion criteria
Exclusion criteria: 1. Previous history of cancer excluding basal cell carcinoma or cervical carcinoma in-situ 2. Previous deep vein thrombosis or pulmonary embolism 3. Uncontrolled hypertension 4. Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack 5. Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication 6. Ongoing cardiac dysrhythmias of >= Grade 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events (CTCAE) grading version 3.0), atrial fibrillation of any grade, or prolongation of the QTc interval >470 msec 7. Treatment with terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, ketoconazole or indapamide 8. Known HIV positive, or acquired immunodeficiency syndrome (AIDS) related illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ki67 response to therapy. Assessed by biopsy analysis pre-, during (week 3) and post-treatment (week 18) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical response rate (cRR), assessed by clinical examination at weeks 3, 9 and 17 2. Radiological response rate (rRR), assessed by US scan at weeks 3, 9 and 17 3. Clinical/radiological response among patients over-expressing EGFR/HER-2, assessed by US scan/clinical examination at weeks 3, 9 and 17 4. Complete pathological response (pCR), assessed from the tumour tissue removed at surgery 5. Circulatory endothelial cells (CEC) and circulatory endothelial progenitor (CEP) levels, assessed by blood sample pre-, during (week 3) and post-treatment (week 18) 6. Analysis of candidate genes and global gene expression profiling to identify molecular markers of response or resistance. Assessed by biopsy analysis pre-, during (week 3) and post-treatment (week 18) 7. Disease free and overall survival. After surgery, patients will have a hospital visit every 6 months for 5 years | — |
Countries
United Kingdom
Outcome results
None listed