Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04616430 | Topical Endoxifen in Women | PHASE2 | COMPLETED | 90 | — | — | Apr 9, 2018 | Sep 4, 2019 | Jul 12, 2021 | 1 | Sweden |
Change, on an individual level, in mammographic breast density, measured at 6 months or when exiting from the study (baseline screening mammography)
| Arm | Type | Description |
|---|---|---|
| Control | PLACEBO_COMPARATOR | Topical Placebo:Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil |
| 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 |
| 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 |
| Name | Type | Description |
|---|---|---|
| Topical endoxifen | DRUG | topical solution |
| Placebo | DRUG | topical |
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...