A multicentre, randomised, double-blind phase II study of crystalline glucosamine sulphate versus placebo in the management of aromatase inhibitor induced arthralgia in post menopausal women with early breast cancer on letrozole

Australia and New Zealand Breast Cancer Trials Group0 sites143 target enrollmentAugust 22, 2011

Overview

No summary available.

Registry

who.int

Start Date

August 22, 2011

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

Female

Sponsor

Australia and New Zealand Breast Cancer Trials Group

•Patients must be female, greater than or equal to 18 years, and be planned to commence letrozole.
•Patients must have histologically or cytologically confirmed hormone receptor positive early breast cancer in whom adjuvant treatment with letrozole is planned (initial, switch or extended situations allowed, provided no prior aromatase inhibitor had been used). Hormone receptor positivity is defined as any positivity of oestrogen and/or progesterone receptor.
•Bilateral breast cancer is allowed provided at least one of the cancers is hormone receptor positive.
•Patients with stage I, II and III disease are eligible. There must be no clinical indication of metastatic disease.
•Patients must be postmenopausal according to the following definitions:
•Prior bilateral oophorectomy;
•Aged 60 years or more and with amenorrhoea for \>1year;
•If the patient has any clinical evidence of ovarian function, FSH and oestradiol levels must be assessed and be in the postmenopausal range;
•Patients who have taken HRT must have ceased HRT at least 8 weeks prior to randomisation and have biochemical (FSH and oestradiol) confirmation of postmenopausal status;
•Aged under 60 years:

•Patients who have received a prior aromatase inhibitor (AI).
•Patients receiving any other investigational agent.
•Patients with metastatic disease.
•Patients with known inflammatory arthritis that have required 3 months or more of continuous use of disease modifying agents (e.g. oral methotrexate, oral prednisone) during the 5 years prior to the date of randomisation.
•History of allergic reactions attributed to glucosamine, glucosamine sulphate or compounds of similar chemical or biologic composition to glucosamine sulphate. This includes shellfish.
•Poorly controlled diabetes. Those with well controlled diabetes may enter this study, provided diabetic control is monitored by a clinician.
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
•Pregnant women are excluded from this study because AIs are not appropriate breast cancer treatment in these patients.
•Patients with previous or concomitant invasive malignancy are not eligible. The exceptions are patients with the following (and only the following) malignancies (previous or concomitant), who are eligible if adequately treated:
•basal or squamous cell carcinoma of the skin