NCT05068388

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2021

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 5, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

December 21, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

2.7 years

First QC Date

September 27, 2021

Last Update Submit

April 25, 2024

Conditions

Breast Density

Outcome Measures

Primary Outcomes (1)

  • Change of mammographic density area (cm2) assessed by iCAD® software

    Change from baseline

    6 months

Secondary Outcomes (5)

  • Change of mammographic density area (cm2) assessed by iCAD® software

    3 months

  • Change of mammographic density area (cm2) assessed by Stratus software

    6 months

  • Change of mammographic density area (cm2) assessed by Stratus software

    3 months

  • Change from baseline responses to the Breast Cancer Prevention Trial Eight Symptom Scale (BESS)

    6 months

  • Comparison of adverse events

    6 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

oral capsule

Drug: Placebo

1 mg (Z)-endoxifen

EXPERIMENTAL

oral capsule

Drug: Z-Endoxifen

2 mg (Z)-endoxifen

EXPERIMENTAL

oral capsule

Drug: Z-Endoxifen

Interventions

Z-EndoxifenDRUG

Z-Endoxifen

1 mg (Z)-endoxifen2 mg (Z)-endoxifen
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age40 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailshaving at least one menstruation during the prior 12 months; women with an intrauterine device are considered premenopausal if \<52 years
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)
  • Women of childbearing potential using a highly effective method of birth control\* throughout the study period and willing to comply with monthly pregnancy testing
  • Mammographic density assessed as BI-RADS® score B, C, or D
  • 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

You may not qualify if:

  • Mammographic BI-RADS® malignancy code ≥3 at baseline mammography
  • A history of breast surgery, e.g., reduction or enlargement, which might affect mammographic density measurements
  • Current medical conditions:
  • APC (activated protein C) resistance, an inherited coagulation disorder
  • Systolic pressure higher than 160 mm Hg or diastolic higher than 100 mm Hg
  • Cataract(s)
  • Uncontrolled diabetes (defined as HbA1c \>50 mmol/mol)
  • Abnormal lab values deemed clinically significant by Investigator
  • BMI \> 30
  • Women who have an increased risk of venous thrombosis due to immobilization, e.g., using wheelchair
  • Agents that have the potential to decrease endoxifen levels through increased metabolic clearance:
  • Certain anti-epileptic therapies (carbamazepine, fenytoin, fenobarbital, lamotrigine)
  • Certain antibiotics (rifamycins)
  • St John's wort (in Swedish: johannesört)
  • Certain HIV medications (efavirenz, ritonavir)
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karma Study Centre

Stockholm, Sweden

Location

MeSH Terms

Interventions

4-hydroxy-N-desmethyltamoxifen

Study Officials

  • Steven Quay, MD

    Atossa Therapeutics, Inc.

    STUDY DIRECTOR

  • Per Hall, MD

    Södersjukhuset, Stockholm, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2021

First Posted

October 5, 2021

Study Start

December 21, 2021

Primary Completion

August 28, 2024

Study Completion

December 31, 2025

Last Updated

April 26, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)