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

NCT03264651 | Completed Phase 1 DMC

• 1 other identifier: CH02ST1
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mammographic Density

Keywords

Selective androgen receptor modulator; Aromatase inhibitor

Outcome Measures

Primary Outcomes (4)

• Mammographic breast density

  Volumetric analysis of fibroglandular density change on mammography utilizing Volpara software

  12 months

• Breast tissue elasticity

  Evaluation of breast elasticity change by direct shear wave ultrasonic measurement

  1 month

• Breast tissue elasticity

  Evaluation of breast elasticity change by direct shear wave ultrasonic measurement

  3 months

• Breast tissue elasticity

  Evaluation of breast elasticity change by direct shear wave ultrasonic measurement

  6 months

Secondary Outcomes (3)

• Breast pain scale

  1 month, 3 months, 12 months

• Serum gonadotropin levels

  1 month, 3 months, 12 months

• Menopausal symptoms

  3 months, 12 months

Study Arms (1)

oral enobosarm and anastrozole

EXPERIMENTAL

9 mg of oral enbosarm and 1 mg of anastrozole daily

Drug: enobosarm

Interventions

enobosarm DRUG

Oral combination therapy of enobosarm and anastrozole

Also known as: anastrozole

oral enobosarm and anastrozole

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Havah Therapeutics Pty Ltd: lead
• GTx: collaborator

Study Sites (1)

Wellend Health

Toorak Gardens, South Australia, 5065, Australia

Location

MeSH Terms

Interventions

ostarine; Anastrozole

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Stephen N Birrell, MD PhD

  Havah Therapeutics Pty Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A single armed group of premenopausal women receiving open labeled medication

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 29, 2017
• Study Start: February 1, 2017
• Primary Completion: March 21, 2018
• Study Completion: March 21, 2018
• Last Updated: April 18, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)