Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Sex
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
1/07/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2009
Actual
Sample size
Target
90
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/ct2/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/ct2/show/NCT00497458