Karolinska Interventional Study of Mammograhic Density (Karisma-1)

NCT04079517 | Completed Phase 1 Results

• 2 other identifiers: 2015-0003452014-005005-20
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Breast Cancer; Mammographic Density

Keywords

Tamoxifen; Low-dose; Randomized Clinical Trial

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• Symptom Score

  9 months

Study Arms (2)

Tamoxifen 10mg

EXPERIMENTAL

Randomised dose of daily oral Tamoxifen 10mg, for 180 days

Drug: Tamoxifen

Tamoxifen 20mg

ACTIVE COMPARATOR

Randomised dose of daily oral Tamoxifen 20mg, for 180 days

Drug: Tamoxifen

Interventions

Tamoxifen DRUG

A registered SERM drug, Tamoxifen.

Tamoxifen 10mg; Tamoxifen 20mg

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Per Hall
• Organization: Karolinska Institutet

per.hall@ki.se

+4670750 2110

Study Officials

• Per Hall, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 6, 2019
• Study Start: March 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: February 6, 2025
• Results First Posted: February 6, 2025

Record last verified: 2025-02