Topical Endoxifen in Women

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-09

Study Completion Date

2019-09-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Mammographic Breast Density

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Control

Topical Placebo:Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

topical

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

Group Type ACTIVE_COMPARATOR

Topical endoxifen

Intervention Type DRUG

topical solution

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

Group Type ACTIVE_COMPARATOR

Topical endoxifen

Intervention Type DRUG

topical solution

Interventions

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Topical endoxifen

topical solution

Intervention Type DRUG

Placebo

topical

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

74 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes