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OpenTrials
Completed

NCT Number: NCT04616430

Topical Endoxifen in Women

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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Key information

Age range

40 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Karolinska Institutet

Stockholm, Sodersjukhuset, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topical endoxifen

Drug

topical solution

Placebo

Drug

topical

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Atossa Therapeutics, Inc.

Industry

Collaborators

  • Karolinska Institutet

Registry information

Official study title

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

Acronym: CREME

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Nov 5, 2020
Registry last updated
Jul 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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