NCT04616430

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 9, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2018

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
8 months until next milestone

Results Posted

Study results publicly available

June 18, 2021

Completed
Last Updated

July 12, 2021

Status Verified

June 1, 2021

Enrollment Period

5 months

First QC Date

October 16, 2020

Results QC Date

May 3, 2021

Last Update Submit

June 17, 2021

Conditions

Mammographic Breast Density

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Control

PLACEBO COMPARATOR

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

Drug: Placebo

Topical Endoxifen 10mg/breast/day

ACTIVE COMPARATOR

10 mg/day topical (Z)-endoxifen; Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil

Drug: Topical endoxifen

Topical Endoxifen 20mg/breast/day

ACTIVE COMPARATOR

20 mg/day topical (Z)-endoxifen; Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil

Drug: Topical endoxifen

Interventions

Topical endoxifenDRUG

topical solution

Topical Endoxifen 10mg/breast/dayTopical Endoxifen 20mg/breast/day
PlaceboDRUG

topical

Control

Eligibility Criteria

Age40 Years - 74 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsheatlhy post-menopausal women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant in the Karma Cohort
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, Sodersjukhuset, Sweden

Location

Related Publications (1)

  • Backlund M, Eriksson M, Gabrielson M, Hammarstrom M, Quay S, Bergqvist J, Hellgren R, Czene K, Hall P. Topical Endoxifen for Mammographic Density Reduction-A Randomized Controlled Trial. Oncologist. 2022 Jul 5;27(7):e597-e600. doi: 10.1093/oncolo/oyac102.

    PMID: 35604960DERIVED

MeSH Terms

Interventions

4-hydroxy-N-desmethyltamoxifen

Limitations and Caveats

Early discontinuation of subjects due to AEs related to skin reactions lead to small numbers of completed subjects and inability to analyze the primary endpoint as outlined in the protocol.

Results Point of Contact

Title
Dr. Steven Quay
Organization
Atossagenetics
steven.quay@atossainc.com
206.419.4873

Study Officials

  • Per Hall, MD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2020

First Posted

November 5, 2020

Study Start

April 9, 2018

Primary Completion

September 10, 2018

Study Completion

September 4, 2019

Last Updated

July 12, 2021

Results First Posted

June 18, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)