CClinicalTrials.gg
Sign In
CompletedNCT03264651Updated Apr 18, 2018

Enobosarm and Anastrozole in Pre-menopausal Women With High Mammographic Breast Density

A Phase 1 interventional study of enobosarm in Mammographic Density, sponsored by Havah Therapeutics Pty Ltd. Completed at 1 site in Australia. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2018-04-18.

Sponsored by Havah Therapeutics Pty Ltd · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
Female
01

Study summary

To evaluate the impact of a selective androgen receptor modulator combined with an aromatase inhibitor in reducing high mammographic breast density.

Read the detailed description

High mammographic breast density is a well recognized risk factor for the development of breast cancer and the masking of malignancy within the breast. Previous chemoprevention studies have revealed that only tamoxifen is efficacious in premenopausal women in the reduction of breast cancer. In order for this to occur mammographic density has to be reduced. Unfortunately the side effect profile of tamoxifen is such that not many women are taking up this therapeutic intervention. This trial is trying to establish a combination therapy to reduce mammographic breast density.

This phase 1 pilot study is combining oral enobosarm, a selective androgen receptor modulator, and oral anastrozole, an aromatase inhibitor, to study the impact of this combination treatment on mammographic breast density and breast elasticity. Safety and tolerability we also analyzed.

02

Conditions studied

  • Mammographic Density

Keywords

  • Selective androgen receptor modulator
  • Aromatase inhibitor
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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;

Exclusion criteria

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
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    oral enobosarm and anastrozole

    9 mg of oral enbosarm and 1 mg of anastrozole daily

    Drug: enobosarm

Interventions

  • Drugenobosarm

    Oral combination therapy of enobosarm and anastrozole

    Also known as: anastrozole

05

What researchers measure

Primary outcomes

  1. Mammographic breast density

    Volumetric analysis of fibroglandular density change on mammography utilizing Volpara software

    Time frame: 12 months

  2. Breast tissue elasticity

    Evaluation of breast elasticity change by direct shear wave ultrasonic measurement

    Time frame: 1 month

  3. Breast tissue elasticity

    Evaluation of breast elasticity change by direct shear wave ultrasonic measurement

    Time frame: 3 months

  4. Breast tissue elasticity

    Evaluation of breast elasticity change by direct shear wave ultrasonic measurement

    Time frame: 6 months

Secondary outcomes

  1. Breast pain scale

    Breast pain measured on a 100 mm visual analog scale

    Time frame: 1 month, 3 months, 12 months

  2. Serum gonadotropin levels

    serum follicular stimulating hormone and luteinizing hormone levels

    Time frame: 1 month, 3 months, 12 months

  3. Menopausal symptoms

    Menopause symptoms as recorded on a menopause symptoms scale

    Time frame: 3 months, 12 months

06

Study locations

1 site
  • Wellend Health
    Toorak Gardens, South Australia 5065, Australia
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03264651
Lead sponsor
Havah Therapeutics Pty Ltd
Collaborators
GTx
Responsible party
Sponsor
First posted
Aug 29, 2017
Start date
Feb 1, 2017
Primary completion
Mar 21, 2018
Completion
Mar 21, 2018
Last update
Apr 18, 2018

Study contacts

Stephen N Birrell, MD PhD
principal investigator · Havah Therapeutics Pty Ltd

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Havah Therapeutics Pty Ltd

Start the discussion