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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00497458




Registration number
NCT00497458
Ethics application status
Date submitted
4/07/2007
Date registered
6/07/2007
Date last updated
9/04/2009

Titles & IDs
Public title
Androgen Therapy for Breast Cancer Patients With Aromatase Inhibitor Induced Side-Effects
Scientific title
Phase II Study of Testosterone Replacement in Women Experiencing Aromatase Inhibitor Side-Effects in Adjuvant Therapy for Breast Cancer
Secondary ID [1] 0 0
ART2
Universal Trial Number (UTN)
Trial acronym
ART2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Arthralgia 0 0
Osteoporosis 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
Musculoskeletal 0 0 0 0
Osteoporosis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Testosterone

Placebo Comparator: Arimidex - Arimidex 1 mg plus placebo

Active Comparator: Arimidex test 40mg - Arimidex 1mg and testosterone 40mg

Active Comparator: Arimidex plus test 80mg - Arimidex 1mg and testosterone 80mg


Treatment: Drugs: Testosterone
testosterone 40 or 80 mg once a day

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
3 months
Primary outcome [2] 0 0
Has acceptable safety and tolerability profile with particular reference to androgenic adverse events including acne, hirsutism, and alopecia.
Timepoint [2] 0 0
3 months
Secondary outcome [1] 0 0
Impacts the bone resorption marker CTx
Timepoint [1] 0 0
3 months
Secondary outcome [2] 0 0
Impacts serum HDL, LDL Trg, total Chol,
Timepoint [2] 0 0
3 months
Secondary outcome [3] 0 0
Impacts serum levels of oestrogens, androgens and SHBG levels
Timepoint [3] 0 0
3 months

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
85 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

- Patients with history of fragility fracture or low BMD, osteoporosis or osteopenia

- Known liver disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Burnside Breast Centre - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Havah Therapeutics Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
AstraZeneca
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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)
Trial website
https://clinicaltrials.gov/show/NCT00497458
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen N Birrell, MD PhD
Address 0 0
Havah Therapeutics Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00497458