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

NCT05068388 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-05-20

No results posted yet for this study

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

Interventions

DRUG

Z-Endoxifen

Z-Endoxifen

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Atossa Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Steven Quay, MD · Atossa Therapeutics, Inc.

  • Per Hall, MD · Södersjukhuset, Stockholm, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-21
Primary Completion
2024-06-14
Completion
2026-03-12

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05068388 on ClinicalTrials.gov