Early breast cancer Cancer Breast cancer
Conditions
Interventions
Patients will be randomised in the ratio of 2:1 to receive anastozole 1 mg or letrozole 2.5 mg daily, taken orally for 4 weeks, commencing 2 weeks before surgery for primary breast cancer. Patients w
Sponsors
Institute of Cancer Research (UK)
Royal Marsden NHS Foundation Trust
Eligibility
Sex/Gender
Female
Age
50 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Postmenopausal women with core biopsy-proven hormone receptor positive invasive breast cancer. Postmenopausal is defined as a woman fulfilling any one of the following criteria: 1.1. Aged greater than 50 years with amenorrhoea greater than 12 months and an intact uterus 1.2. Has undergone a bilateral oophorectomy 1.3. In women who have undergone a hysterectomy, then Follicle Stimulating Hormone (FSH) levels within the postmenopausal range (utilising ranges from the testing laboratory facility) are required if the patient is aged less than 55 years 1.4. In women who have been on Hormone Replacement Therapy (HRT) within the last 12 months and therefore not amenorrhoeic, FSH levels within the postmenopausal range (utilising ranges from the testing laboratory facility) are required if the patient is aged less than 55 years 2. No evidence of metastatic spread by standard assessment according to local guidelines 3. Standard adjuvant endocrine therapy indicated 4. A palpable tumour of any minimum size, or a tumour with an ultrasound size of at least 1.5 cm 5. World Health Organization (WHO) performance status of 0, 1, or 2 6. Written informed consent to participate in the trial and to donation of tissue (fresh tissue and surplus tissue from diagnostic procedures)
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 11/10/2012: 1. Locally advanced/inoperable breast cancer 2. Evidence of metastatic disease 3. Concurrent use of HRT 4. Prior endocrine therapy for breast cancer 5. Neoadjuvant chemotherapy 6. Any invasive malignancy within previous 5 years (other than basal cell carcinoma or cervical carcinoma in situ) 7. Any severe coincident medical disease or inability to give informed consent 8. Treatment with a non-approved or investigational drug within 4 weeks before randomisation 9. Previous invasive breast cancer or bilateral breast cancer (surgically treated DCIS or LCIS allowed) 10. Previous use of oestrogen implants at ANY time 11. Continuous long term systemic steroid usage Previous exclusion criteria until 11/10/2012: 1. Locally advanced/inoperable breast cancer 2. Evidence of metastatic disease 3. Concurrent use of HRT 4. Prior endocrine therapy for breast cancer 5. Neoadjuvant chemotherapy 6. Any invasive malignancy within previous 5 years (other than basal cell carcinoma or cervical carcinoma in situ) 7. Any severe coincident medical disease or inability to give informed consent 8. Treatment with a non-approved or investigational drug within 4 weeks before randomisation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 11/10/2012: Relapse free survival (clinical endpoint) Previous primary outcome measures until 11/10/2012: 1. 5-year relapse free survival, planned for mid-2016 2. Proliferation rate (Ki67) at baseline core biopsy, and at surgical excision (both groups) to determine the relative accuracy of baseline and 2 week Ki67 in predicting outcome using pre-treatment and on-treatment values | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 11/10/2012: 1. Time to local recurrence 2. Time to distant recurrence 3. Overall survival, planned for mid-2016 4. Gene expression profile at core biopsy and at surgical excision (both groups) to determine the relative accuracy of baseline and 2 week profiles in predicting outcome with pre-treatment and on-treatment 5. Proliferation rate (Ki67) at baseline core biopsy, and at surgical excision (biological endpoint) Previous secondary outcome measures until 11/10/2012: 1. Time to local recurrence 2. Time to distant recurrence 3. Overall survival, planned for mid-2016 4. Gene expression profile at core biopsy and at surgical excision (both groups) to determine the relative accuracy of baseline and 2 week profiles in predicting outcome with pre-treatment and on-treatment | — |
Countries
England, United Kingdom
Outcome results
None listed