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

Mammographic Density Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03264651
• Other study ID #: CH02ST1
• Status: Completed
• Phase: Phase 1
• First received: August 14, 2017
• Last updated: April 17, 2018
• Start date: February 1, 2017
• Est. completion date: March 21, 2018

Study information

• Verified date: February 2018
• Source: Havah Therapeutics Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 21, 2018
• Est. primary completion date: March 21, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Mammographic Density

Intervention

Drug:
• enobosarm
Oral combination therapy of enobosarm and anastrozole

Locations

Country	Name	City	State
Australia	Wellend Health	Toorak Gardens	South Australia

Sponsors (2)

Lead Sponsor	Collaborator
Havah Therapeutics Pty Ltd	GTx

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mammographic breast density	Volumetric analysis of fibroglandular density change on mammography utilizing Volpara software	12 months
Primary	Breast tissue elasticity	Evaluation of breast elasticity change by direct shear wave ultrasonic measurement	1 month
Primary	Breast tissue elasticity	Evaluation of breast elasticity change by direct shear wave ultrasonic measurement	3 months
Primary	Breast tissue elasticity	Evaluation of breast elasticity change by direct shear wave ultrasonic measurement	6 months
Secondary	Breast pain scale	Breast pain measured on a 100 mm visual analog scale	1 month, 3 months, 12 months
Secondary	Serum gonadotropin levels	serum follicular stimulating hormone and luteinizing hormone levels	1 month, 3 months, 12 months
Secondary	Menopausal symptoms	Menopause symptoms as recorded on a menopause symptoms scale	3 months, 12 months