Mammographic DensityPhase 1NCT03264651
Enobosarm and Anastrozole in Pre-menopausal Women With High Mammographic Breast Density
A Phase 1 study testing enobosarm in people with Mammographic Density, run by Havah Therapeutics Pty Ltd at 1 site in Australia.
Trial summary
To evaluate the impact of a selective androgen receptor modulator combined with an aromatase inhibitor in reducing high mammographic breast density. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Mammographic Density
- What is being tested?
- enobosarm
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Feb 2017to 21 Mar 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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;
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Centre Pilot Trial Investigating the Efficacy and Safety of Enobosarm and Anastrozole in Pre-menopausal Women With High Mammographic Breast Density
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.
- Conditions
- Mammographic Density
- Being tested
- enobosarm
- Keywords
- Selective androgen receptor modulator, Aromatase inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enobosarmDrug
Also called anastrozole
Oral combination therapy of enobosarm and anastrozole
| Study group | Role | What they receive |
|---|---|---|
| oral enobosarm and anastrozole | Experimental | 9 mg of oral enbosarm and 1 mg of anastrozole daily Receives: Drug: enobosarm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mammographic breast density
Volumetric analysis of fibroglandular density change on mammography utilizing Volpara software
Measured: 12 months
Breast tissue elasticity
Evaluation of breast elasticity change by direct shear wave ultrasonic measurement
Measured: 1 month
Breast tissue elasticity
Evaluation of breast elasticity change by direct shear wave ultrasonic measurement
Measured: 3 months
Breast tissue elasticity
Evaluation of breast elasticity change by direct shear wave ultrasonic measurement
Measured: 6 months
Secondary outcomes (3)
Breast pain scale
Breast pain measured on a 100 mm visual analog scale
Measured: 1 month, 3 months, 12 months
Serum gonadotropin levels
serum follicular stimulating hormone and luteinizing hormone levels
Measured: 1 month, 3 months, 12 months
Menopausal symptoms
Menopause symptoms as recorded on a menopause symptoms scale
Measured: 3 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start1 Feb 2017
- Primary completion21 Mar 2018
- Study completion21 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mammographic DensityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single armed group of premenopausal women receiving open labeled medication
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Havah Therapeutics Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GTx
- Responsible party
- Sponsor
- Investigators
- Stephen N Birrell, MD PhD, Principal investigator, Havah Therapeutics Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264651
- Sponsor's protocol ID
- CH02ST1
- Status last verified
- Feb 2018
- First submitted
- 14 Aug 2017
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Centre Pilot Trial Investigating the Efficacy and Safety of Enobosarm and Anastrozole in Pre-menopausal Women With High Mammographic Breast Density
- ClinicalTrials.gov ID
- NCT03264651
- Acronym / sponsor ID
- CH02ST1
- Conditions
- Mammographic Density
- Keywords
- Selective androgen receptor modulator, Aromatase inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Havah Therapeutics Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- GTx
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 21 Mar 2018 (actual)
- Study completion
- 21 Mar 2018 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the impact of a selective androgen receptor modulator combined with an aromatase inhibitor in reducing high mammographic breast density.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single armed group of premenopausal women receiving open labeled medication
| Arm | Type | Receives |
|---|---|---|
| oral enobosarm and anastrozole | Experimental | Drug: enobosarm9 mg of oral enbosarm and 1 mg of anastrozole daily |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enobosarmAlso: anastrozoleOral combination therapy of enobosarm and anastrozole | Drug | oral enobosarm and anastrozole |
Primary outcome
Mammographic breast density
Time frame: 12 months
Volumetric analysis of fibroglandular density change on mammography utilizing Volpara software
Breast tissue elasticity
Time frame: 1 month
Evaluation of breast elasticity change by direct shear wave ultrasonic measurement
Breast tissue elasticity
Time frame: 3 months
Evaluation of breast elasticity change by direct shear wave ultrasonic measurement
Breast tissue elasticity
Time frame: 6 months
Evaluation of breast elasticity change by direct shear wave ultrasonic measurement
3 secondary outcomes
Breast pain scale
Time frame: 1 month, 3 months, 12 months
Serum gonadotropin levels
Time frame: 1 month, 3 months, 12 months
Menopausal symptoms
Time frame: 3 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen N Birrell, MD PhD principal investigator
Havah Therapeutics Pty Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing enobosarm in people with Mammographic Density, run by Havah Therapeutics Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mammographic breast density (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.