Karma CREME-1: A Double-blind, Placebo-controlled, Three-armed, Pilot Study of the Effects, Safety and Tolerability of Topical Endoxifen in Women Within the Karma Cohort
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Atossa Therapeutics, Inc.
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Change in Mammographic Breast Density At Study Exit
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 40 Years to 74 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Control
Topical Placebo:Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil
Intervention: Placebo (Drug)
Topical Endoxifen 10mg/breast/day
10 mg/day topical (Z)-endoxifen; Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil
Intervention: Topical endoxifen (Drug)
Topical Endoxifen 20mg/breast/day
20 mg/day topical (Z)-endoxifen; Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil
Intervention: Topical endoxifen (Drug)
Outcomes
Primary Outcomes
Change in Mammographic Breast Density At Study Exit
Time Frame: 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)
Secondary Outcomes
No secondary outcomes reported