Short term biological study effects of Zoledronate and Letrozole on invasive breast cancer - Short term effects (preoperative) of Femara and Zometa or Femara alone

Phase 1

• Conditions: Breast Cancer

• Registration Number: EUCTR2004-004223-36-GB
• Lead Sponsor: South Manchester University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-07-01
• Study Completion: 2009-05-22
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 110

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

. 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).

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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.