Trial Outcomes & Findings for Karolinska Interventional Study of Mammograhic Density (Karisma-1) (NCT NCT04079517)
NCT ID: NCT04079517
Last Updated: 2025-02-06
Results Overview
Mean change in mammographic breast density at 6 months compared to baseline (=0 months) for each dose arm, using the fully automated STRATUS method. The average percent density (fibroglandular dense tissue area divided by total breast area) of left and right breasts at baseline was calculated and compared with average percent density at the end of the trial period and density change was defined as the difference between these two measures.
COMPLETED
PHASE1/PHASE2
42 participants
6 months
2025-02-06
Participant Flow
Participant milestones
| Measure |
Tamoxifen 10mg
Randomised dose of daily oral Tamoxifen 10mg, for 180 days
Tamoxifen: A registered SERM drug, Tamoxifen.
|
Tamoxifen 20mg
Randomised dose of daily oral Tamoxifen 20mg, for 180 days
Tamoxifen: A registered SERM drug, Tamoxifen.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
19
|
|
Overall Study
COMPLETED
|
18
|
15
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Karolinska Interventional Study of Mammograhic Density (Karisma-1)
Baseline characteristics by cohort
| Measure |
Tamoxifen 10mg
n=23 Participants
Randomised dose of daily oral Tamoxifen 10mg, for 180 days
Tamoxifen: A registered SERM drug, Tamoxifen.
|
Tamoxifen 20mg
n=19 Participants
Randomised dose of daily oral Tamoxifen 20mg, for 180 days
Tamoxifen: A registered SERM drug, Tamoxifen.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.74 years
STANDARD_DEVIATION 8.48 • n=5 Participants
|
62.32 years
STANDARD_DEVIATION 6.74 • n=7 Participants
|
61.5 years
STANDARD_DEVIATION 5.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
23 participants
n=5 Participants
|
19 participants
n=7 Participants
|
42 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The final analysis was restricted to the 19 plus 14 participants.
Mean change in mammographic breast density at 6 months compared to baseline (=0 months) for each dose arm, using the fully automated STRATUS method. The average percent density (fibroglandular dense tissue area divided by total breast area) of left and right breasts at baseline was calculated and compared with average percent density at the end of the trial period and density change was defined as the difference between these two measures.
Outcome measures
| Measure |
Tamoxifen 10mg
n=19 Participants
Randomised dose of daily oral Tamoxifen 10mg, for 270 days. Tamoxifen: A registered SERM drug, Tamoxifen.
|
Tamoxifen 20mg
n=14 Participants
Randomised dose of daily oral Tamoxifen 20mg, for 270 days. Tamoxifen: A registered SERM drug, Tamoxifen.
|
|---|---|---|
|
Mammographic Breast Density
|
-3.3 percentage of breast area
Interval -6.1 to -0.5
|
-2.5 percentage of breast area
Interval -2.5 to 0.8
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Participants answering baseline and 9 month questionnaires.
Symptom score change, compared to baseline for each dose arm. Questionnaires were used at 0, 1, 3, 6, 9 months. Vasomotor, gynecological, sexual, and musculoskeletal symptoms were assessed using a 5-grade Likert severity scale ranging from "no symptom at all" to "very much symptoms". A higher symptom score equals less symptoms, i.e. a better outcome. The questionnaire was based on the Functional Assessment of Cancer Therapy - Endocrine Subscale 7 (FACT-ES.7). The presented score was calculated as the sum of the last month's symptom severity levels and are presented as the absolute differences in symptom score on a scale ranging from any minus five to any plus five. A higher symptom score equals less symptoms, i.e. a better outcome.
Outcome measures
| Measure |
Tamoxifen 10mg
n=18 Participants
Randomised dose of daily oral Tamoxifen 10mg, for 270 days. Tamoxifen: A registered SERM drug, Tamoxifen.
|
Tamoxifen 20mg
n=12 Participants
Randomised dose of daily oral Tamoxifen 20mg, for 270 days. Tamoxifen: A registered SERM drug, Tamoxifen.
|
|---|---|---|
|
Symptom Score
|
1.8 score on a scale
Interval -0.8 to 4.5
|
3.7 score on a scale
Interval 0.5 to 6.8
|
Adverse Events
Tamoxifen 10mg
Tamoxifen 20mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tamoxifen 10mg
n=23 participants at risk
Randomised dose of daily oral Tamoxifen 10mg, for 180 days
Tamoxifen: A registered SERM drug, Tamoxifen.
|
Tamoxifen 20mg
n=19 participants at risk
Randomised dose of daily oral Tamoxifen 20mg, for 180 days
Tamoxifen: A registered SERM drug, Tamoxifen.
|
|---|---|---|
|
Nervous system disorders
Numbness/tingling in the hands and feet
|
13.0%
3/23 • Number of events 3
|
26.3%
5/19 • Number of events 5
|
|
Nervous system disorders
Mood swings
|
26.1%
6/23 • Number of events 6
|
31.6%
6/19 • Number of events 6
|
|
Nervous system disorders
Headaches
|
43.5%
10/23 • Number of events 10
|
47.4%
9/19 • Number of events 9
|
|
Nervous system disorders
Concentration ability impaired
|
4.3%
1/23 • Number of events 1
|
10.5%
2/19 • Number of events 2
|
|
Nervous system disorders
Feeling sad
|
13.0%
3/23 • Number of events 3
|
26.3%
5/19 • Number of events 5
|
|
Nervous system disorders
Irritable
|
21.7%
5/23 • Number of events 5
|
36.8%
7/19 • Number of events 7
|
|
Nervous system disorders
Lack of energy
|
26.1%
6/23 • Number of events 6
|
36.8%
7/19 • Number of events 7
|
|
Nervous system disorders
Worry
|
30.4%
7/23 • Number of events 7
|
31.6%
6/19 • Number of events 6
|
|
Nervous system disorders
Eyesight changes
|
26.1%
6/23 • Number of events 6
|
42.1%
8/19 • Number of events 8
|
|
Nervous system disorders
Difficulty sleeping
|
47.8%
11/23 • Number of events 11
|
47.4%
9/19 • Number of events 9
|
|
Nervous system disorders
Feel lightheaded (dizzy)
|
17.4%
4/23 • Number of events 4
|
21.1%
4/19 • Number of events 4
|
|
Reproductive system and breast disorders
Vaginal bleeding or spotting
|
0.00%
0/23
|
10.5%
2/19 • Number of events 2
|
|
Reproductive system and breast disorders
Vaginal discharge
|
30.4%
7/23 • Number of events 7
|
57.9%
11/19 • Number of events 11
|
|
Reproductive system and breast disorders
Sexual feeling decreased
|
39.1%
9/23 • Number of events 9
|
52.6%
10/19 • Number of events 10
|
|
Reproductive system and breast disorders
Vaginal itching/irritation
|
13.0%
3/23 • Number of events 3
|
26.3%
5/19 • Number of events 5
|
|
Reproductive system and breast disorders
Pain from breast tissue or breast skin
|
17.4%
4/23 • Number of events 4
|
26.3%
5/19 • Number of events 5
|
|
Reproductive system and breast disorders
Fragile mucous membranes/ Mucous membrane disorder
|
30.4%
7/23 • Number of events 7
|
52.6%
10/19 • Number of events 10
|
|
Reproductive system and breast disorders
Painful intercourse
|
17.4%
4/23 • Number of events 4
|
26.3%
5/19 • Number of events 5
|
|
Reproductive system and breast disorders
Dryness vaginal
|
47.8%
11/23 • Number of events 11
|
73.7%
14/19 • Number of events 14
|
|
Skin and subcutaneous tissue disorders
skin rashes
|
26.1%
6/23 • Number of events 6
|
21.1%
4/19 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Hair loss
|
30.4%
7/23 • Number of events 7
|
36.8%
7/19 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Itching
|
13.0%
3/23 • Number of events 3
|
0.00%
0/19
|
|
Renal and urinary disorders
Problems with urination
|
8.7%
2/23 • Number of events 2
|
15.8%
3/19 • Number of events 3
|
|
Endocrine disorders
Cold sweat
|
34.8%
8/23 • Number of events 8
|
47.4%
9/19 • Number of events 9
|
|
Endocrine disorders
Night sweats
|
65.2%
15/23 • Number of events 15
|
94.7%
18/19 • Number of events 18
|
|
Endocrine disorders
Menopausal hot flushes
|
60.9%
14/23 • Number of events 14
|
89.5%
17/19 • Number of events 17
|
|
Musculoskeletal and connective tissue disorders
muscle cramps (e.g. in legs)
|
60.9%
14/23 • Number of events 14
|
84.2%
16/19 • Number of events 16
|
|
Musculoskeletal and connective tissue disorders
Pain in joints
|
52.2%
12/23 • Number of events 12
|
57.9%
11/19 • Number of events 11
|
|
Metabolism and nutrition disorders
Diarrhoea
|
26.1%
6/23 • Number of events 6
|
15.8%
3/19 • Number of events 3
|
|
Metabolism and nutrition disorders
Constipation
|
17.4%
4/23 • Number of events 4
|
26.3%
5/19 • Number of events 5
|
|
Metabolism and nutrition disorders
weight gain
|
52.2%
12/23 • Number of events 12
|
73.7%
14/19 • Number of events 14
|
|
Metabolism and nutrition disorders
Nausea
|
30.4%
7/23 • Number of events 7
|
31.6%
6/19 • Number of events 6
|
|
Metabolism and nutrition disorders
Vomiting
|
52.2%
12/23 • Number of events 12
|
68.4%
13/19 • Number of events 13
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place