Effect of Oral (Z)-Endoxifen in Premenopausal Women With Measurable Breast Density

NCT ID: NCT05068388

Last Updated: 2024-04-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-21
• Study Completion Date: 2025-12-31

Brief Summary

This is a randomized, double-blinded, placebo-controlled dose-response efficacy study of oral (Z)-endoxifen in premenopausal women with measurable breast density. There will be 5 in-clinic visits (Screening, Day 1, Months 1, 3 and 6) and 3 self-report visits (Months 2, 4 and 5). Standard of care mammograms will be used for the screening mammogram as well as the 24-month follow up visit.

Conditions

Breast Density

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

oral capsule

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

1 mg (Z)-endoxifen

oral capsule

Group Type: EXPERIMENTAL

Z-Endoxifen

Intervention Type: DRUG

Z-Endoxifen

2 mg (Z)-endoxifen

oral capsule

Group Type: EXPERIMENTAL

Z-Endoxifen

Intervention Type: DRUG

Z-Endoxifen

Interventions

Z-Endoxifen

Z-Endoxifen

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Premenopausal women (defined as having at least one menstruation during the prior 12 months; women with an intrauterine device are considered premenopausal if <52 years)

2. Women of childbearing potential using a highly effective method of birth control* throughout the study period and willing to comply with monthly pregnancy testing

3. Screening mammogram performed within 3 month of study inclusion

4. Mammographic density assessed as BI-RADS® score B, C, or D

5. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects

Exclusion Criteria

1. Mammographic BI-RADS® malignancy code ≥3 at baseline mammography

3. A history of breast surgery, e.g., reduction or enlargement, which might affect mammographic density measurements

4. Current medical conditions:

1. APC (activated protein C) resistance, an inherited coagulation disorder

2. Systolic pressure higher than 160 mm Hg or diastolic higher than 100 mm Hg

3. Cataract(s)

4. Uncontrolled diabetes (defined as HbA1c >50 mmol/mol)

5. Abnormal lab values deemed clinically significant by Investigator

5. BMI > 30

6. Women who have an increased risk of venous thrombosis due to immobilization, e.g., using wheelchair

7. Agents that have the potential to decrease endoxifen levels through increased metabolic clearance:

1. Certain anti-epileptic therapies (carbamazepine, fenytoin, fenobarbital, lamotrigine)

2. Certain antibiotics (rifamycins)

3. St John's wort (in Swedish: johannesört)

4. Certain HIV medications (efavirenz, ritonavir)

8. Lactating, pregnant, or plan to become pregnant in the next year

9. History of thromboembolic disease such as embolus, deep vein thrombosis, stroke, TIA (transient ischemic attack) or myocardial infarction

10. Allergy to endoxifen or any of its components

11. Previous treatment with an anti-oestrogen, including experimental drug studies (e.g., Karma CREME, Karisma-1 or Karisma-2)

12. Prescribed and regular use of anticoagulants (defined as substances included in group B01A in the ATC-system)

13. Participation in another investigational clinical trial in the last 6 months

14. Not willing or able to understand the study information and/or informed consent

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Atossa Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Quay, MD

Role: STUDY_DIRECTOR

Atossa Therapeutics, Inc.

Per Hall, MD

Role: PRINCIPAL_INVESTIGATOR

Södersjukhuset, Stockholm, Sweden

Locations

Karma Study Centre

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

ATOS-016R

Identifier Type: -

Identifier Source: org_study_id