Topical Endoxifen in Women

Mammographic Breast Density Clinical Trial

— CREME  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04616430
• Other study ID #: ATOS-010
• Status: Completed
• Phase: Phase 2
• Start date: April 9, 2018
• Est. completion date: September 4, 2019

Study information

• Verified date: June 2021
• Source: Atossa Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 4, 2019
• Est. primary completion date: September 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mammographic Breast Density

Intervention

Drug:
• Topical endoxifen
topical solution
• Placebo
topical

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm	Sodersjukhuset

Sponsors (2)

Lead Sponsor	Collaborator
Atossa Genetics, Inc.	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

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