Topical Endoxifen in Women

Phase 2

Completed

• Conditions: Mammographic Breast Density
• Interventions: Drug: Placebo; Drug: Topical endoxifen

• Registration Number: NCT04616430
• Lead Sponsor: Atossa Therapeutics, Inc.

Brief Summary

Karma CREME-1 consisted of 90 participants from the Karma Cohort. The major focus of the pilot trial was to estimate time to mammographic density change. The primary objective was to determine the effect size of the breast density change between topical placebo and two doses of topical endoxifen.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-09
• Primary Completion: 2018-09-10
• Study Completion: 2019-09-04
• Study First Submitted: 2020-10-16
• Study First Submitted QC: 2020-11-04
• Study First Posted: 2020-11-05
• Results First Submitted: 2021-05-03
• Results First Submitted QC: 2021-05-26
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-17
• Results First Posted: 2021-06-18
• Last Update Posted: 2021-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• Participant in the Karma Cohort
• Attending the national mammography screening program, i.e., aged 40-74 and have performed a screening mammogram maximum 3 months prior to study inclusion
• Mammographic density ~4.5 % density (volumetric) measured by Volpara, at the screening mammogram performed in connection to baseline (maximum 3 months prior to inclusion). The threshold value of 4.5% corresponds to the clinical Bl-RADS score A
• Postmenopausal, defined as no period of menstruation during last 12 months independent of any hormonal treatment
• Informed consent must be signed before any study specific assessments are performed

Exclusion Criteria

• Any previous or current diagnosis of breast cancer (including carcinoma in situ).
• Any previous diagnosis of cancer with the exception of non-melanoma skin cancer and in situ cancer of the cervix.
• A history of major surgery of the breast, e.g., reduction or enlargement, which might affect density measurements.
• Mammographic Bl-RADS malignancy code 3, or above, at baseline mammography, or at mammography during time of treatment. Recall for additional examinations due to technical problems with the mammogram is accepted.
• Currently using estrogen and progesterone based hormone replacement therapy (oral or patches). Local estrogen treatment is accepted (ex. Vagifem).
• Non-medical approved drugs against hot-flashes including phytoestrogen.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	Topical Placebo:Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil
Topical Endoxifen 10mg/breast/day	Topical endoxifen	10 mg/day topical (Z)-endoxifen; Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil
Topical Endoxifen 20mg/breast/day	Topical endoxifen	20 mg/day topical (Z)-endoxifen; Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil

Primary Outcome Measures

Name	Time	Method
Change in Mammographic Breast Density At Study Exit	From baseline to study exit up to 6 months	Change, on an individual level, in mammographic breast density, measured at 6 months or when exiting from the study (baseline screening mammography)

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sodersjukhuset, Sweden