Trial Outcomes & Findings for Topical Endoxifen in Women (NCT NCT04616430)
NCT ID: NCT04616430
Last Updated: 2021-07-12
Results Overview
Change, on an individual level, in mammographic breast density, measured at 6 months or when exiting from the study (baseline screening mammography)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
90 participants
Primary outcome timeframe
From baseline to study exit up to 6 months
Results posted on
2021-07-12
Participant Flow
Participant milestones
| Measure |
Control
Topical Placebo:Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil
Placebo: topical
|
Topical Endoxifen 10mg/Breast/Day
10 mg/day topical (Z)-endoxifen; Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil
Topical endoxifen: topical solution
|
Topical Endoxifen 20mg/Breast/Day
20 mg/day topical (Z)-endoxifen; Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil
Topical endoxifen: topical solution
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
30
|
|
Overall Study
COMPLETED
|
23
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
28
|
30
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control
n=30 Participants
Topical Placebo:Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil
Placebo: topical
|
Topical Endoxifen 10mg/Breast/Day
n=30 Participants
10 mg/day topical (Z)-endoxifen; Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil
Topical endoxifen: topical solution
|
Topical Endoxifen 20mg/Breast/Day
n=30 Participants
20 mg/day topical (Z)-endoxifen; Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil
Topical endoxifen: topical solution
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.9 years
STANDARD_DEVIATION 6.01 • n=30 Participants
|
56.9 years
STANDARD_DEVIATION 7.97 • n=30 Participants
|
57.7 years
STANDARD_DEVIATION 8.41 • n=30 Participants
|
56.5 years
STANDARD_DEVIATION 7.5 • n=90 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
90 Participants
n=90 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=90 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Sweden
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
90 Participants
n=90 Participants
|
|
BMI
|
24.9 kg/m^2
STANDARD_DEVIATION 2.77 • n=30 Participants
|
25.6 kg/m^2
STANDARD_DEVIATION 3.57 • n=30 Participants
|
25.2 kg/m^2
STANDARD_DEVIATION 3.08 • n=30 Participants
|
25.2 kg/m^2
STANDARD_DEVIATION 3.1 • n=90 Participants
|
|
Blood pressure (systolic)
|
117.5 mm Hg
STANDARD_DEVIATION 12.1 • n=30 Participants
|
123.7 mm Hg
STANDARD_DEVIATION 8.45 • n=30 Participants
|
120.4 mm Hg
STANDARD_DEVIATION 10.1 • n=30 Participants
|
120.5 mm Hg
STANDARD_DEVIATION 10.5 • n=90 Participants
|
|
Weight
|
69.0 kg
STANDARD_DEVIATION 7.33 • n=30 Participants
|
69.8 kg
STANDARD_DEVIATION 9.74 • n=30 Participants
|
70.2 kg
STANDARD_DEVIATION 9.31 • n=30 Participants
|
69.7 kg
STANDARD_DEVIATION 8.8 • n=90 Participants
|
|
Height
|
166.6 cm
STANDARD_DEVIATION 5.14 • n=30 Participants
|
165.3 cm
STANDARD_DEVIATION 6.38 • n=30 Participants
|
167.0 cm
STANDARD_DEVIATION 6.06 • n=30 Participants
|
166.3 cm
STANDARD_DEVIATION 5.9 • n=90 Participants
|
|
Mammographic Breast Density
|
23.6 % Dense Tissue
STANDARD_DEVIATION 17.2 • n=30 Participants
|
23.9 % Dense Tissue
STANDARD_DEVIATION 12.9 • n=30 Participants
|
26.2 % Dense Tissue
STANDARD_DEVIATION 18 • n=30 Participants
|
24.6 % Dense Tissue
STANDARD_DEVIATION 16.0 • n=90 Participants
|
|
Blood pressure (diastolic)
|
77.0 mm Hg
STANDARD_DEVIATION 7.13 • n=30 Participants
|
79.7 mm Hg
STANDARD_DEVIATION 5.86 • n=30 Participants
|
77.0 mm Hg
STANDARD_DEVIATION 7.13 • n=30 Participants
|
77.4 mm Hg
STANDARD_DEVIATION 7.4 • n=90 Participants
|
PRIMARY outcome
Timeframe: From baseline to study exit up to 6 monthsPopulation: Due to dropouts, analysis could only be performed 1 time at study exit. Participants were encouraged to have a mammogram at study exit; not all did.
Change, on an individual level, in mammographic breast density, measured at 6 months or when exiting from the study (baseline screening mammography)
Outcome measures
| Measure |
Control
n=26 Participants
Topical Placebo:Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil
Placebo: topical
|
Topical Endoxifen 10mg/Breast/Day
n=21 Participants
10 mg/day topical (Z)-endoxifen; Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil
Topical endoxifen: topical solution
|
Topical Endoxifen 20mg/Breast/Day
n=27 Participants
20 mg/day topical (Z)-endoxifen; Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil
Topical endoxifen: topical solution
|
|---|---|---|---|
|
Change in Mammographic Breast Density At Study Exit
|
-1.85 percent change from baseline
Standard Deviation 5.58
|
-2.14 percent change from baseline
Standard Deviation 6.50
|
-3.75 percent change from baseline
Standard Deviation 7.81
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Topical Endoxifen 10mg/Breast/Day
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Topical Endoxifen 20mg/Breast/Day
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=30 participants at risk
Topical Placebo:Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil
Placebo: topical
|
Topical Endoxifen 10mg/Breast/Day
n=30 participants at risk
10 mg/day topical (Z)-endoxifen; Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil
Topical endoxifen: topical solution
|
Topical Endoxifen 20mg/Breast/Day
n=30 participants at risk
20 mg/day topical (Z)-endoxifen; Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil
Topical endoxifen: topical solution
|
|---|---|---|---|
|
Cardiac disorders
Rapid heart rate or palpitations
|
43.3%
13/30 • Number of events 25 • Up to 6 months
|
10.0%
3/30 • Number of events 4 • Up to 6 months
|
13.3%
4/30 • Number of events 5 • Up to 6 months
|
|
Ear and labyrinth disorders
Feel lightheaded (dizzy)
|
46.7%
14/30 • Number of events 20 • Up to 6 months
|
33.3%
10/30 • Number of events 15 • Up to 6 months
|
13.3%
4/30 • Number of events 5 • Up to 6 months
|
|
Eye disorders
Eyesight changes
|
30.0%
9/30 • Number of events 15 • Up to 6 months
|
16.7%
5/30 • Number of events 8 • Up to 6 months
|
16.7%
5/30 • Number of events 7 • Up to 6 months
|
|
Gastrointestinal disorders
Constipation
|
10.0%
3/30 • Number of events 4 • Up to 6 months
|
16.7%
5/30 • Number of events 7 • Up to 6 months
|
6.7%
2/30 • Number of events 2 • Up to 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
5/30 • Number of events 6 • Up to 6 months
|
10.0%
3/30 • Number of events 3 • Up to 6 months
|
6.7%
2/30 • Number of events 2 • Up to 6 months
|
|
Gastrointestinal disorders
Difficulty swallowing
|
3.3%
1/30 • Number of events 1 • Up to 6 months
|
0.00%
0/30 • Up to 6 months
|
3.3%
1/30 • Number of events 1 • Up to 6 months
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
5/30 • Number of events 6 • Up to 6 months
|
10.0%
3/30 • Number of events 3 • Up to 6 months
|
3.3%
1/30 • Number of events 2 • Up to 6 months
|
|
Gastrointestinal disorders
Feel bloated
|
43.3%
13/30 • Number of events 24 • Up to 6 months
|
33.3%
10/30 • Number of events 13 • Up to 6 months
|
13.3%
4/30 • Number of events 5 • Up to 6 months
|
|
Gastrointestinal disorders
Nausea
|
13.3%
4/30 • Number of events 5 • Up to 6 months
|
6.7%
2/30 • Number of events 2 • Up to 6 months
|
3.3%
1/30 • Number of events 1 • Up to 6 months
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
1/30 • Number of events 1 • Up to 6 months
|
3.3%
1/30 • Number of events 1 • Up to 6 months
|
3.3%
1/30 • Number of events 1 • Up to 6 months
|
|
General disorders
Burning feeling from breast tissue or breast skin
|
20.0%
6/30 • Number of events 11 • Up to 6 months
|
16.7%
5/30 • Number of events 8 • Up to 6 months
|
23.3%
7/30 • Number of events 8 • Up to 6 months
|
|
General disorders
Fragile mucous membranes
|
60.0%
18/30 • Number of events 39 • Up to 6 months
|
46.7%
14/30 • Number of events 22 • Up to 6 months
|
46.7%
14/30 • Number of events 14 • Up to 6 months
|
|
General disorders
Irritation from the breast skin
|
26.7%
8/30 • Number of events 13 • Up to 6 months
|
40.0%
12/30 • Number of events 14 • Up to 6 months
|
50.0%
15/30 • Number of events 17 • Up to 6 months
|
|
General disorders
Itching from the breast skin
|
20.0%
6/30 • Number of events 14 • Up to 6 months
|
70.0%
21/30 • Number of events 36 • Up to 6 months
|
73.3%
22/30 • Number of events 36 • Up to 6 months
|
|
General disorders
Lack of energy
|
10.0%
3/30 • Number of events 6 • Up to 6 months
|
20.0%
6/30 • Number of events 6 • Up to 6 months
|
10.0%
3/30 • Number of events 3 • Up to 6 months
|
|
General disorders
Pain
|
13.3%
4/30 • Number of events 5 • Up to 6 months
|
10.0%
3/30 • Number of events 3 • Up to 6 months
|
3.3%
1/30 • Number of events 1 • Up to 6 months
|
|
General disorders
Pain from breast tissue or breast skin
|
10.0%
3/30 • Number of events 4 • Up to 6 months
|
13.3%
4/30 • Number of events 7 • Up to 6 months
|
10.0%
3/30 • Number of events 3 • Up to 6 months
|
|
General disorders
Redness on breast skin
|
13.3%
4/30 • Number of events 7 • Up to 6 months
|
30.0%
9/30 • Number of events 10 • Up to 6 months
|
30.0%
9/30 • Number of events 9 • Up to 6 months
|
|
General disorders
Swelling of arms or legs
|
6.7%
2/30 • Number of events 3 • Up to 6 months
|
0.00%
0/30 • Up to 6 months
|
0.00%
0/30 • Up to 6 months
|
|
Investigations
Deviating lab value
|
0.00%
0/30 • Up to 6 months
|
0.00%
0/30 • Up to 6 months
|
3.3%
1/30 • Number of events 1 • Up to 6 months
|
|
Investigations
Weight gain
|
50.0%
15/30 • Number of events 31 • Up to 6 months
|
30.0%
9/30 • Number of events 14 • Up to 6 months
|
13.3%
4/30 • Number of events 4 • Up to 6 months
|
|
Metabolism and nutrition disorders
Lack of appetite
|
6.7%
2/30 • Number of events 2 • Up to 6 months
|
0.00%
0/30 • Up to 6 months
|
0.00%
0/30 • Up to 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps (e.g. in legs)
|
60.0%
18/30 • Number of events 38 • Up to 6 months
|
36.7%
11/30 • Number of events 14 • Up to 6 months
|
36.7%
11/30 • Number of events 14 • Up to 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in joints
|
46.7%
14/30 • Number of events 34 • Up to 6 months
|
33.3%
10/30 • Number of events 16 • Up to 6 months
|
36.7%
11/30 • Number of events 12 • Up to 6 months
|
|
Nervous system disorders
Difficulty concentrating
|
13.3%
4/30 • Number of events 4 • Up to 6 months
|
0.00%
0/30 • Up to 6 months
|
6.7%
2/30 • Number of events 2 • Up to 6 months
|
|
Nervous system disorders
Feeling drowsy
|
6.7%
2/30 • Number of events 2 • Up to 6 months
|
6.7%
2/30 • Number of events 2 • Up to 6 months
|
6.7%
2/30 • Number of events 2 • Up to 6 months
|
|
Nervous system disorders
Headaches
|
56.7%
17/30 • Number of events 31 • Up to 6 months
|
36.7%
11/30 • Number of events 16 • Up to 6 months
|
16.7%
5/30 • Number of events 6 • Up to 6 months
|
|
Nervous system disorders
Numbness/tingling in the hands and feet
|
16.7%
5/30 • Number of events 5 • Up to 6 months
|
6.7%
2/30 • Number of events 2 • Up to 6 months
|
6.7%
2/30 • Number of events 2 • Up to 6 months
|
|
Psychiatric disorders
Difficulty sleeping
|
43.3%
13/30 • Number of events 20 • Up to 6 months
|
30.0%
9/30 • Number of events 9 • Up to 6 months
|
13.3%
4/30 • Number of events 4 • Up to 6 months
|
|
Psychiatric disorders
Feeling nervous
|
0.00%
0/30 • Up to 6 months
|
6.7%
2/30 • Number of events 2 • Up to 6 months
|
3.3%
1/30 • Number of events 1 • Up to 6 months
|
|
Psychiatric disorders
Feeling sad
|
13.3%
4/30 • Number of events 6 • Up to 6 months
|
10.0%
3/30 • Number of events 4 • Up to 6 months
|
6.7%
2/30 • Number of events 2 • Up to 6 months
|
|
Psychiatric disorders
Irritable
|
30.0%
9/30 • Number of events 22 • Up to 6 months
|
33.3%
10/30 • Number of events 12 • Up to 6 months
|
16.7%
5/30 • Number of events 6 • Up to 6 months
|
|
Psychiatric disorders
Mood swings
|
26.7%
8/30 • Number of events 21 • Up to 6 months
|
30.0%
9/30 • Number of events 9 • Up to 6 months
|
20.0%
6/30 • Number of events 6 • Up to 6 months
|
|
Psychiatric disorders
Sexual feeling decreased
|
76.7%
23/30 • Number of events 50 • Up to 6 months
|
63.3%
19/30 • Number of events 28 • Up to 6 months
|
50.0%
15/30 • Number of events 15 • Up to 6 months
|
|
Psychiatric disorders
Worry
|
20.0%
6/30 • Number of events 8 • Up to 6 months
|
3.3%
1/30 • Number of events 1 • Up to 6 months
|
0.00%
0/30 • Up to 6 months
|
|
Renal and urinary disorders
Problems with urination
|
0.00%
0/30 • Up to 6 months
|
3.3%
1/30 • Number of events 1 • Up to 6 months
|
6.7%
2/30 • Number of events 2 • Up to 6 months
|
|
Reproductive system and breast disorders
Breast sensitivity/tenderness
|
26.7%
8/30 • Number of events 13 • Up to 6 months
|
26.7%
8/30 • Number of events 10 • Up to 6 months
|
26.7%
8/30 • Number of events 8 • Up to 6 months
|
|
Reproductive system and breast disorders
Dryness vaginal
|
73.3%
22/30 • Number of events 46 • Up to 6 months
|
73.3%
22/30 • Number of events 33 • Up to 6 months
|
43.3%
13/30 • Number of events 14 • Up to 6 months
|
|
Reproductive system and breast disorders
Menopausal hot flushes
|
63.3%
19/30 • Number of events 48 • Up to 6 months
|
46.7%
14/30 • Number of events 22 • Up to 6 months
|
53.3%
16/30 • Number of events 17 • Up to 6 months
|
|
Reproductive system and breast disorders
Night sweats
|
70.0%
21/30 • Number of events 47 • Up to 6 months
|
43.3%
13/30 • Number of events 19 • Up to 6 months
|
46.7%
14/30 • Number of events 15 • Up to 6 months
|
|
Reproductive system and breast disorders
Painful intercourse
|
63.3%
19/30 • Number of events 41 • Up to 6 months
|
53.3%
16/30 • Number of events 24 • Up to 6 months
|
46.7%
14/30 • Number of events 15 • Up to 6 months
|
|
Reproductive system and breast disorders
Vaginal bleeding or spotting
|
3.3%
1/30 • Number of events 3 • Up to 6 months
|
6.7%
2/30 • Number of events 2 • Up to 6 months
|
6.7%
2/30 • Number of events 2 • Up to 6 months
|
|
Reproductive system and breast disorders
Vaginal discharge
|
33.3%
10/30 • Number of events 25 • Up to 6 months
|
30.0%
9/30 • Number of events 12 • Up to 6 months
|
13.3%
4/30 • Number of events 5 • Up to 6 months
|
|
Reproductive system and breast disorders
Vaginal itching/irritation
|
16.7%
5/30 • Number of events 12 • Up to 6 months
|
20.0%
6/30 • Number of events 10 • Up to 6 months
|
13.3%
4/30 • Number of events 4 • Up to 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
3/30 • Number of events 3 • Up to 6 months
|
10.0%
3/30 • Number of events 3 • Up to 6 months
|
10.0%
3/30 • Number of events 5 • Up to 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
6.7%
2/30 • Number of events 4 • Up to 6 months
|
3.3%
1/30 • Number of events 1 • Up to 6 months
|
3.3%
1/30 • Number of events 1 • Up to 6 months
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
16.7%
5/30 • Number of events 11 • Up to 6 months
|
13.3%
4/30 • Number of events 6 • Up to 6 months
|
10.0%
3/30 • Number of events 4 • Up to 6 months
|
|
Skin and subcutaneous tissue disorders
Hair loss
|
30.0%
9/30 • Number of events 19 • Up to 6 months
|
30.0%
9/30 • Number of events 14 • Up to 6 months
|
26.7%
8/30 • Number of events 8 • Up to 6 months
|
|
Skin and subcutaneous tissue disorders
Itching
|
13.3%
4/30 • Number of events 5 • Up to 6 months
|
26.7%
8/30 • Number of events 10 • Up to 6 months
|
40.0%
12/30 • Number of events 14 • Up to 6 months
|
|
Skin and subcutaneous tissue disorders
Rashes on breast skin
|
40.0%
12/30 • Number of events 24 • Up to 6 months
|
70.0%
21/30 • Number of events 35 • Up to 6 months
|
86.7%
26/30 • Number of events 43 • Up to 6 months
|
|
Skin and subcutaneous tissue disorders
Skin rashes
|
43.3%
13/30 • Number of events 20 • Up to 6 months
|
43.3%
13/30 • Number of events 19 • Up to 6 months
|
56.7%
17/30 • Number of events 22 • Up to 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place