Androgen Therapy for Breast Cancer Patients With Aromatase Inhibitor Induced Side-Effects

NCT00497458 | Unknown Phase 2

• 1 other identifier: ART2
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate whether increasing blood levels of androgen can reduce some of the side-effects of anti-estrogen therapy (Arimidex)

Conditions

Breast Cancer; Arthralgia; Osteoporosis

Keywords

breast; neoplasms; anastrazole; testosterone

Outcome Measures

Primary Outcomes (2)

• Reduces arthralgia and associated joint symptoms as indicated by the change in hand or large joint pain from baseline to 3 months using a 100mm visual analogue scale for pain.

  3 months

• Has acceptable safety and tolerability profile with particular reference to androgenic adverse events including acne, hirsutism, and alopecia.

  3 months

Secondary Outcomes (3)

• Impacts the bone resorption marker CTx

  3 months

• Impacts serum HDL, LDL Trg, total Chol,

  3 months

• Impacts serum levels of oestrogens, androgens and SHBG levels

  3 months

Study Arms (3)

Arimidex

PLACEBO COMPARATOR

Arimidex 1 mg plus placebo

Drug: Testosterone

Arimidex test 40mg

ACTIVE COMPARATOR

Arimidex 1mg and testosterone 40mg

Drug: Testosterone

Arimidex plus test 80mg

ACTIVE COMPARATOR

Arimidex 1mg and testosterone 80mg

Drug: Testosterone

Interventions

Testosterone DRUG

testosterone 40 or 80 mg once a day

Arimidex; Arimidex plus test 80mg; Arimidex test 40mg

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of written informed consent
• Undergone a total mastectomy, a lumpectomy or a quadrantectomy for primary breast cancer +/-chemo, +/-radiotherapy
• Have commenced anastrozole therapy within the previous 6 months
• Presence of node negative or positive disease
• Receptor-positive tumors, defined as ER ≥10% of the tumor cells positive by immunocytochemical evaluation
• Postmenopausal whether induced by surgery, radiotherapy (chemotherapy-induced amenorrhea may be difficult to determine they may be amenorrhoeic but still have functioning ovaries), or by being naturally amenorrhoeic, for 1 year or more if younger than 50 and for 6 months if 50 or older
• Postmenopausal levels of FSH/LH/E2 (follicle stimulating hormone, luteinizing hormone, oestrogen) according to the definition of "postmenopausal range" for the laboratory involved
• Have developed arthralgia and associated joint symptoms whilst being treated with anastrozole with a score of 40mm or greater on a pain and stiffness 100mm VAS
• WBC ≥ 3.0 x 109/L, granulocytes ≥ 1.5 X 109/L and platelets ≥ 100 x 109/L.
• AST/SGOT or ALT/SGPT ≤ 3 times ULN Serum creatinine ≤ 2 times ULN

You may not qualify if:

• Presence of metastatic disease
• Diabetes mellitus or glucose intolerance defined as a fasting glucose \>6mmol/l
• Previous or concomitant other (non-breast cancer) malignancy within the previous 5 years
• Presence of other non-malignant systemic diseases which may prevent prolonged follow-up
• History of coronary artery disease or no history of previous coronary heart disease but at least two other coronary heart disease risk factors: LDL ≥8.8 mg/dL OR if fewer than two other coronary heart disease risk factors: LDL ≥10.45 mg/dL or total fasting cholesterol ≥ 13.2 mg/dL
• Patients on hormone replacement therapy (HRT) within 4 weeks before trial treatment was initiated
• Patients on breast cancer chemoprevention with anti-oestrogens if less than 18 months between stopping and diagnosis of breast cancer
• Are at risk of transmitting Human Immunodeficiency Virus or viral hepatitis via infected blood
• Known hypersensitivity to any component of testosterone
• Unable to comply with study requirements
• Taking the following concomitant medications at the screening visit-bisphosphonate, anti-cancer treatment other than anastrozole (this includes Herceptin).
• Prolonged systemic corticosteroid treatment, except for topical applications (e.g. for rash), inhaled sprays (e.g. for obstructive airways diseases), eye drops or local injections (e.g. intra-articular). Note: Short duration (\< 2 weeks) of systemic corticosteroids is allowed (e.g. for Chronic Obstructive Pulmonary Disease) but not within 1 month prior to randomisation.
• Any investigational drugs
• Systemic hormone replacement therapy
• Pregnant or lactating women

Sponsors & Collaborators

• Havah Therapeutics Pty Ltd: lead
• AstraZeneca: collaborator

Study Sites (1)

Burnside Breast Centre

Adelaide, South Australia, Australia

Location

MeSH Terms

Conditions

Breast Neoplasms; Arthralgia; Osteoporosis; Neoplasms

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bone Diseases, Metabolic; Bone Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Stephen N Birrell, MD PhD

  Havah Therapeutics Pty Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 4, 2007
• First Posted: July 6, 2007
• Study Start: July 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: June 1, 2009
• Last Updated: April 9, 2009

Record last verified: 2009-04

Locations

AU (1)