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

Breast Density Clinical Trial

Official title:

A Phase 2, Randomized, Double-blinded, Placebo-controlled, Dose-Response Study of Oral (Z)-Endoxifen in Premenopausal Women With Measurable Breast Density

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05068388
• Other study ID #: ATOS-016R
• Status: Recruiting
• Phase: Phase 2
• Start date: December 21, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2022
• Source: Atossa Therapeutics, Inc.
• Contact: Heather Fraser, PhD
• Phone: 206-707-3088
• Email: heather.fraser[@]atossainc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2025
• Est. primary completion date: August 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 55 Years

Eligibility

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

2. Any previous diagnosis of breast cancer, including carcinoma in situ, or any other cancer (non-melanoma skin cancer and in situ cancer of the cervix are not exclusion criteria)

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

Related Conditions & MeSH terms

• Breast Density

Intervention

Drug:
• Z-Endoxifen
Z-Endoxifen
• Placebo
Placebo

Locations

Country	Name	City	State
Sweden	Karma Study Centre	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Atossa Therapeutics, Inc.

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of mammographic density area (cm2) assessed by iCAD® software	Change from baseline	6 months
Secondary	Change of mammographic density area (cm2) assessed by iCAD® software	Change from baseline	3 months
Secondary	Change of mammographic density area (cm2) assessed by Stratus software	Change from baseline	6 months
Secondary	Change of mammographic density area (cm2) assessed by Stratus software	Change from baseline	3 months
Secondary	Change from baseline responses to the Breast Cancer Prevention Trial Eight Symptom Scale (BESS)	5-point Likert-type scale	6 months
Secondary	Comparison of adverse events	assessment of adverse events	6 months