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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03264651




Registration number
NCT03264651
Ethics application status
Date submitted
14/08/2017
Date registered
29/08/2017
Date last updated
18/04/2018

Titles & IDs
Public title
Enobosarm and Anastrozole in Pre-menopausal Women With High Mammographic Breast Density
Scientific title
A Single-Centre Pilot Trial Investigating the Efficacy and Safety of Enobosarm and Anastrozole in Pre-menopausal Women With High Mammographic Breast Density
Secondary ID [1] 0 0
CH02ST1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mammographic Density 0 0
Condition category
Condition code

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

Experimental: oral enobosarm and anastrozole - 9 mg of oral enbosarm and 1 mg of anastrozole daily


Treatment: Drugs: enobosarm
Oral combination therapy of enobosarm and anastrozole
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mammographic breast density
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Breast tissue elasticity
Timepoint [2] 0 0
1 month
Primary outcome [3] 0 0
Breast tissue elasticity
Timepoint [3] 0 0
3 months
Primary outcome [4] 0 0
Breast tissue elasticity
Timepoint [4] 0 0
6 months
Secondary outcome [1] 0 0
Breast pain scale
Timepoint [1] 0 0
1 month, 3 months, 12 months
Secondary outcome [2] 0 0
Serum gonadotropin levels
Timepoint [2] 0 0
1 month, 3 months, 12 months
Secondary outcome [3] 0 0
Menopausal symptoms
Timepoint [3] 0 0
3 months, 12 months

Eligibility
Key inclusion criteria
- Provision of written informed consent

- Pre-menopausal levels of FSH/LH/E2 (follicle stimulating hormone, luteinizing hormone,
oestrogen) according to the definition of "pre-menopausal range" for the laboratory
involved

- Have a Volpara Density volumetric breast density of >15.5% (combined average both
breasts)

- Breast pain in the previous month of equal to or greater than 40mm on a 100mm visual
analogue pain scale

- 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

- eGFR> 60 ml/min/1.73m2

- Negative pregnancy test in women of childbearing potential (premenopausal or less than
12 months of amenorrhea post-menopause, and who have not undergone surgical
sterilization), no more than 7 days before the first dose of study treatment;

- For women of childbearing potential who are sexually active, agreement to use a highly
effective, non-hormonal form of contraception during and for at least 6 months after
completion of study treatment; OR, a fertile male partner willing and able to use
effective non-hormonal means of contraception (barrier method of contraception in
conjunction with spermicidal jelly, or surgical sterilization) during and for at least
6 months after completion of study treatment;
Minimum age
18 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Presence of breast cancer

- 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 (other than skin cancer)

- History of coronary artery disease

- Systemic hormonal contraception

- 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

- Prolonged systemic corticosteroid treatment

- Any investigational drugs

- Systemic hormone replacement therapy

- Pregnant or lactating women

- Known liver disease

- Current warfarin usage

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/03/2018
Sample size
Target
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Wellend Health - Toorak Gardens
Recruitment postcode(s) [1] 0 0
5065 - Toorak Gardens

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
GTx
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
To evaluate the impact of a selective androgen receptor modulator combined with an aromatase
inhibitor in reducing high mammographic breast density.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03264651
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/NCT03264651