Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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/study/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
Not applicable
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/study/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/study/NCT03264651