Breast Cancer
Conditions
Interventions
Trade Name: Femara
Product Name: Letrozole
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
South Manchester University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: . oestrogen receptor positive (>10%) invasive breast cancer . signed written informed consent . Postmenopausal status as defined by one of the following:- Age greater than 55 years with cessation of menses Age less than 55 but no spontaneous menses for at least one year Bilateral oophorectomy Ageless than 55 and spontaneous menses within the last year with postmenopausal gonadotrophin Levels (LH and FSH levels greater than 40 IU?L) or postmenopausal oestradiol levels (less than 5 ng/dL). . Hormone receptor positive tumours as defined by ER and PR greater than 10% of tumour cells positive by immunohistochemical staining (or Allred score >2) . Patients must have surgically operable breast cancer, which has not received prior systemic (i.e. adjuvant chemotherapy) or local (radiotherapy) treatments according to best practice . Patients must consent to or have undergone a core biopsy for the diagnosis of their breast cancer 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
Exclusion criteria: . Oestrogen receptor negative (<10%) (or Allred score 0 or 1) or ER unknown invasive breast cancer . Patients on hormone replacement therapy at diagnosis . Patients who have received prior treatment with oral or intravenous bisphosphonates within the last twelve months . Known hypersensitivity to Zometa (zoledronic acid) or other bisphosphonates . Abnormal renal function as defined by serum creatinine and equal to or greater than 3mg/dL (265.2mmol/L).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine if Zoledronate increases effects of Letrozole on inhibition of breast cancer proliferation and apoptosis ;Secondary Objective: Determine if Zoledronate decreases angiogenesis between pre-treatment, operation and 21 days post operative in patients undergoing surgery for breast cancer. ;Primary end point(s): Reduction in Ki67 immunostaining between the operative tumour sample and the preoperative core biopsy. | — |
Countries
United Kingdom
Outcome results
None listed