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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05068388
Other study ID # ATOS-016R
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date December 21, 2021
Est. completion date December 31, 2025

Study information

Verified date April 2024
Source Atossa Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
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 Active, not 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

Study Design


Related Conditions & MeSH terms


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
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