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

Phase 1

• Conditions: Women 75 years or over with invasive, operable, moderate or strongly ER+ve, primary breast cancer.; MedDRA version: 8.1Level: LLTClassification code 10006187Term: Breast cancer

• Registration Number: EUCTR2006-003932-32-GB
• Lead Sponsor: The University of Leeds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-22
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

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

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

(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.

Study & Design

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