ACTRN12611000891921WithdrawnPhase 2
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 enrollmentStarted: August 22, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Enrollment
- 143
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Prevention
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- Female
Inclusion Criteria
- •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:
- •with a uterus and amenorrhoea for at least 12 months prior to trial entry
- •with a uterus and amenorrhoea for less than 12 months prior to trial entry, FSH and oestradiol levels must be in the post-menopausal range
- •without a uterus, FSH and oestradiol level must be in the postmenopausal range
- •with a uterus and amenorrhoea following endometrial ablation or adjuvant chemotherapy. FSH and oestradiol levels must be in the postmenopausal range
- •May have received prior glucosamine (including current) provided patient is willing to withdraw her glucosamine product (by the day of randomisation) if current and to be randomised
- •May have received prior adjuvant tamoxifen for up to 6 years prior to randomisation. Tamoxifen must have ceased, but not more than 6 months previously
- •Must have completed adjuvant chemotherapy and radiotherapy if this has been prescribed. May be receiving trastuzumab if indicated
- •Patients must have normal organ and marrow function as defined below:
- •WBC >2.0x109/L
- •Absolute neutrophil count >1.5x109 /L
- •Platelets >100x109/L
- •Total bilirubin within normal institutional limits (unless patient has Gilbert’s syndrome)
- •AST/ALT 2.5 X institutional upper limit of normal
- •Creatinine 1.5 X institutional upper limit of normal
- •Life expectancy of greater than 2 years.
- •Patients must have an ECOG performance status of 0 – 2.
- •Written informed consent must be signed and dated by the patient and the investigator prior to randomisation.
- •Patients must be willing and able to undergo the required assessment schedule.
Exclusion Criteria
- •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
- •in situ non-breast carcinoma without invasion
- •contra- or ipsilateral in situ breast carcinoma
- •non-breast invasive malignancy diagnosed at least 5 years ago and without recurrence
Investigators
Similar Trials
Active, not recruiting
Phase 1
Multi-centre, randomised, double-blind phase II study comparing cediranib (AZD2171) plus gefitinib (Iressa, ZD1839) with cediranib plus placebo in subjects with recurrent/progressive glioblastoma (DORIC Trial) - Phase II trial of cediranib +/- gefitinib for recurrent glioblastomaGlioblastomaEUCTR2010-021531-13-GBJoint UCLH and UCL Biomedical Research Unit38
Active, not recruiting
Not Applicable
A phase IIa multicentre randomised double-blind, double-dummy study to evaluate the efficacy and safety of K-111 versus Fenofibrate in patients with hyperlipidaemia.HyperlipidaemiaEUCTR2004-002090-23-CZKowa Research Europe Ltd.99
Active, not recruiting
Not Applicable
A phase IIa multicentre randomised double-blind, double-dummy study to evaluate the efficacy and safety of K-111 versus Fenofibrate in patients with hyperlipidaemia.HyperlipidaemiaEUCTR2004-002090-23-HUKowa Research Europe Ltd.99
Active, not recruiting
Not Applicable
Double-blind, randomized, multi-centre phase II study to evaluate the efficacy and safety of topically applied LAS41007 once daily and LAS41007 twice daily versus Solaraze® 3% gel twice daily in the treatment of actinic keratosis grade I to II - LAS41007Patients aged 18 and older suffering from actinic keratoses. Patients to be considered have at least four and up to ten actinic keratoses of grade I to grade II in two treatment blocks of 25 cm2 each within the face/forehead (excluding eyelids, lips and mucosa) or bald scalp.MedDRA version: 9.1Level: LLTClassification code 10000614Term: Actinic keratosisEUCTR2009-012063-33-DEAlmirall Hermal GmbH100
Active, not recruiting
Not Applicable
A randomised phase II multicentre, double blind, parallel group, placebo controlled study of ACR16 50 mg once daily for the symptomatic treatment of Huntington diseaseEUCTR2004-000394-60-SEA. Carlsson Research AB60