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

• Status: Completed
• Trial end date: 2018-03-21
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Havah Therapeutics Pty Ltd
• Collaborator: GTx
• Treatments: Anastrozole

Criteria

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:

• 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