Status:
COMPLETED
Enobosarm and Anastrozole in Pre-menopausal Women With High Mammographic Breast Density
Lead Sponsor:
Havah Therapeutics Pty Ltd
Collaborating Sponsors:
GTx
Conditions:
Mammographic Density
Eligibility:
FEMALE
18-55 years
Phase:
PHASE1
Brief Summary
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2018
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03264651
Start Date
February 1 2017
End Date
March 21 2018
Last Update
April 18 2018
Active Locations (1)
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1
Wellend Health
Toorak Gardens, South Australia, Australia, 5065