Endocrine +/- Surgical Therapy for Elderly women with Mammary cancer

Completed

• Conditions: Breast cancer; Cancer

• Registration Number: ISRCTN36767778
• Lead Sponsor: The University of Sheffield (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-30
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1200

Inclusion Criteria

1. Female patients 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 oEstrogen Receptor (ER) positive, i.e. H score greater than or equal to 100 or Allred score greater than or equal to five
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 four weeks of randomisation

* The inclusion criteria do not restrict for health status as we wish to leave flexibility for surgeons around the country to offer trial participation to those women for whom they feel PET is a reasonable option. This will give Surgeons discretion to select patients according to their own current practice and also give us a breadth of patient fitness levels, which will enable discrimination of those who are and are not suitable for PET on analysis.

Exclusion Criteria

1. Disease unsuitable for surgery, e.g., locally advanced or metastatic disease, extreme physical frailty precluding adequate surgery under either local or general anaesthesia
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 ten 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 greater than 3 x Upper Limit of Normal [ULN] or bilirubin greater than 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

The presence of osteoporosis at baseline is NOT an exclusion criteria.

Study & Design

• Study Type: Interventional
• Study Design: Not specified