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

South Manchester University Hospital0 个研究点目标入组 110 人开始时间: 2005年7月1日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•. 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

•. 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).

发起方

South Manchester University Hospital