Topical Endoxifen in Women (CREME)

Atossa Therapeutics

Status and phase: Completed; Phase 2

Conditions: Mammographic Breast Density

Treatments: Drug: Topical endoxifen; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04616430

ATOS-010

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: Female

Ages: 40 to 74 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Topical Endoxifen 10mg/breast/day

Active Comparator group

Description:

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

Treatment:

Drug: Topical endoxifen

Topical Endoxifen 20mg/breast/day

Active Comparator group

Description:

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

Treatment:

Drug: Topical endoxifen