Breast CancerPhase 1/2Karisma-1NCT04079517
Karolinska Interventional Study of Mammograhic Density (Karisma-1)
A Phase 1/2 study testing Tamoxifen in people with Breast Cancer and Mammographic Density, run by Karolinska Institutet.
Trial summary
A feasibility study, randomising to either 10 or 20 mg of tamoxifen. The primary aim is to identify the time to mammographic density change and piloting the procedures. It is known that a density change is seen after 12 months of 20 mg of tamoxifen, but the clinical experience indicates that an effect of drugs… Read more about this study
- Who is it for?
- Ages 40 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Mammographic Density
- What is being tested?
- Tamoxifen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Mar 2016
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Previously participated in the Karma study
- Attending the national mammography screening program, i.e. aged 40-74
- A mammogram, including a stored raw image, must have been taken within 3 weeks of baseline and start of therapy
- Having a mammographic volumetric density above the lowest 1/6, measured by Volpara
- Informed consent must be signed before any study specific assessments have been performed
Who cannot join
- Being pregnant or planning to become pregnant during the study
- Any previous or current diagnosis of breast cancer (including carcinoma in situ)
- Recalled (mammographic code 3 or above) after baseline screening mammography
- Any previous diagnosis of cancer, with the exception of non-melanoma skin cancer and in situ cancer of the cervix
- Currently using oestrogen and progesterone-based hormone replacement therapy
- Current use of hormone contraceptive with hormones, e.g. hormonal contraceptive pills, or progesterone implants. Hormonal intrauterine devices are accepted.
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- A history of thromboembolic disease such as embolism, deep vein thrombosis, stroke, TIA or cardiac arrest.
- A history of immobilization, e.g. using wheelchair
- Uncontrolled diabetes defined as known untreated diabetes
- Hypertension at baseline, defined as systolic pressure higher than 140 mm Hg and diastolic higher than 90 mm Hg
- Use of drugs that interfere with CYP2D6 expression such as paroxetine, fluoxetine and bupropion
About this study
Official title: A Randomized, Open Pilot Study to Investigate the Mammographic Density Reduction on Healthy Women, Within the Karma Cohort, for Two Different Doses of Tamoxifen
A feasibility study, randomising to either 10 or 20 mg of tamoxifen. The primary aim is to identify the time to mammographic density change and piloting the procedures. It is known that a density change is seen after 12 months of 20 mg of tamoxifen, but the clinical experience indicates that an effect of drugs influencing mammographic density could be seen already after a few months. The second aim is to evaluate if there is a density change from 10 mg of tamoxifen equivalent to 20 mg.
Read the detailed description
The investigators want to conduct a feasibility study including 42 women who will be randomised to either 10 or 20 mg of daily oral tamoxifen. The primary aim of the study is to identify the time to mammographic density change and piloting the procedures. It is known that a density change is seen after 12 months of 20 mg of daily tamoxifen, but the clinical experience indicates that an effect of drugs influencing mammographic density could be seen already after a few months. The second aim of the pilot study is to see if there is a density change from 10 mg of tamoxifen equivalent to 20 mg and if there is a difference in adverse reactions between the two doses. Interim analysis will be performed at 6 months, monitoring both safety and level of mammographic density change.
- Conditions
- Breast Cancer, Mammographic Density
- Being tested
- Tamoxifen
- Keywords
- Tamoxifen, Low-dose, Randomized Clinical Trial
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamoxifenDrug
A registered SERM drug, Tamoxifen.
| Study group | Role | What they receive |
|---|---|---|
| Tamoxifen 10mg | Experimental | Randomised dose of daily oral Tamoxifen 10mg, for 180 days Receives: Drug: Tamoxifen |
| Tamoxifen 20mg | Active comparator | Randomised dose of daily oral Tamoxifen 20mg, for 180 days Receives: Drug: Tamoxifen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mammographic Breast Density
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.
Measured: 6 months
Secondary outcomes (1)
Symptom Score
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study startMar 2015
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical Trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Hall, Karolinska Institutet
- Investigators
- Per Hall, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079517
- Sponsor's protocol ID
- 2015-000345
- Other IDs
- 2014-005005-20, 2014, 2015
- Acronym
- Karisma-1
- Status last verified
- Feb 2025
- First submitted
- 3 Sep 2019
- Last updated
- 6 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Pilot Study to Investigate the Mammographic Density Reduction on Healthy Women, Within the Karma Cohort, for Two Different Doses of Tamoxifen
- ClinicalTrials.gov ID
- NCT04079517
- Acronym / sponsor ID
- Karisma-1 / 2015-000345
- Conditions
- Breast Cancer, Mammographic Density
- Keywords
- Tamoxifen, Low-dose, Randomized Clinical Trial
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Posted 6 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A feasibility study, randomising to either 10 or 20 mg of tamoxifen. The primary aim is to identify the time to mammographic density change and piloting the procedures. It is known that a density change is seen after 12 months of 20 mg of tamoxifen, but the clinical experience indicates that an effect of drugs influencing mammographic density could be seen already after a few months. The second aim is to evaluate if there is a density change from 10 mg of tamoxifen equivalent to 20 mg.
Detailed description
The investigators want to conduct a feasibility study including 42 women who will be randomised to either 10 or 20 mg of daily oral tamoxifen. The primary aim of the study is to identify the time to mammographic density change and piloting the procedures. It is known that a density change is seen after 12 months of 20 mg of daily tamoxifen, but the clinical experience indicates that an effect of drugs influencing mammographic density could be seen already after a few months. The second aim of the pilot study is to see if there is a density change from 10 mg of tamoxifen equivalent to 20 mg and if there is a difference in adverse reactions between the two doses. Interim analysis will be performed at 6 months, monitoring both safety and level of mammographic density change.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Tamoxifen 10mg | Experimental | Drug: TamoxifenRandomised dose of daily oral Tamoxifen 10mg, for 180 days |
| Tamoxifen 20mg | Active comparator | Drug: TamoxifenRandomised dose of daily oral Tamoxifen 20mg, for 180 days |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Previously participated in the Karma study
- Attending the national mammography screening program, i.e. aged 40-74
- A mammogram, including a stored raw image, must have been taken within 3 weeks of baseline and start of therapy
- Having a mammographic volumetric density above the lowest 1/6, measured by Volpara
- Informed consent must be signed before any study specific assessments have been performed
Key exclusion criteria (11 listed)
- Being pregnant or planning to become pregnant during the study
- Any previous or current diagnosis of breast cancer (including carcinoma in situ)
- Recalled (mammographic code 3 or above) after baseline screening mammography
- Any previous diagnosis of cancer, with the exception of non-melanoma skin cancer and in situ cancer of the cervix
- Currently using oestrogen and progesterone-based hormone replacement therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TamoxifenA registered SERM drug, Tamoxifen. | Drug | Tamoxifen 10mg, Tamoxifen 20mg |
Primary outcome
Mammographic Breast Density
Time frame: 6 months
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.
1 secondary outcome
Symptom Score
Time frame: 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Hall, MD, PhD principal investigator
Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tamoxifen in people with Breast Cancer and Mammographic Density, run by Karolinska Institutet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mammographic Breast Density (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.