Women 75 years or over with invasive, operable, moderate or strongly ER+ve, primary breast cancer. MedDRA version: 8.1 Level: LLT Classification code 10006187 Term: Breast cancer
Conditions
Interventions
Trade Name: Arimidex
Pharmaceutical Form: Tablet
Sponsors
The University of Leeds
The University of Sheffield
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Female and equal to or over 75 years of age. (2) Primary operable (TNM categories: T1, T2, T3, N0, N1, M0) invasive breast cancer (core biopsy or diagnostic incision biopsy proven). (3) Suitable for surgery. This may include local or general anaesthesia, and must remove all clinically palpable disease with clear pathological margins. Axillary staging for the clinically un-involved axilla will depend on local protocols and patient tolerance. (4) Moderate or strongly ER+ve, i.e. H Score equal to or greater than 100 or Allred Score equal to or greater than 5. (5) Ability to give informed consent. (6) Written informed consent. (7) Willing to complete the questionnaires for the additional trial evaluations. (8) Able to start trial treatment within 4 weeks of randomisation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: (1) Disease unsuitable for surgery, e.g. locally advanced or metastatic disease, extreme physical frailty precluding adequate surgery under either LA or GA. (2) Multifocal or bilateral invasive breast cancer. (3) Previous invasive breast cancer. (4) Previous or concurrent anti-oestrogen therapy for breast cancer. (5) Previous solid cancers other than breast in the last 10 years (except in the case of completely excised basal cell carcinoma/nonmelanomatous skin malignancy). (6) Inability to comply with study procedures. (7) History of severe renal impairment (creatinine clearance less than 20 ml/min). (8) History of moderate or severe hepatic disease (transaminases > 3 x ULN or bilirubin > 1.5 x ULN). (9) Known hypersensitivity to anastrozole or to any of the following excipients: Lactose Monohydrate, Povidone, Sodium Starch Glycollate, Magnesium Stearate, Hypromellose, Macrogol 300, or Titanium Dioxide. (10) Concurrent hormone replacement therapy (HRT) or therapy with any other oestrogen containing preparation. (11) Hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: To compare surgery plus Arimidex with Arimidex alone in older women with ER+ve breast cancer in terms of overall survival in order to determine whether Arimidex alone provides anti-cancer efficacy which is not inferior to surgery plus adjuvant Arimidex therapy.;Secondary Objective: Secondary objectives: To compare surgery plus Arimidex with Arimidex alone in older women with ER+ve breast cancer in terms of: • quality of life (QoL), in order to determine whether Arimidex alone is superior to surgery plus Arimidex in terms of QoL; • breast cancer specific survival, • failure-free survival and • local disease control, as secondary outcome measures to assess non-inferior anti-cancer efficacy of Arimidex alone; • health economic assessment; Contralateral breast cancer rates, treatment related adverse events and skeletal related events will also be summarised. Further objectives: Development of a patient selection tool based on: • Patient Characteristics • Disease Characteristics Translational studies: To determine the molecular changes associated with the development of secondary Arimidex therapy resistance. ;Primary end point(s): Overall survival (OS) from randomisation | — |
Countries
United Kingdom
Outcome results
None listed