Could a daily pill lower breast cancer risk by reducing breast density?
NCT ID NCT05068388
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested an oral drug called (Z)-endoxifen in 240 premenopausal women with high breast density, a known risk factor for breast cancer. Over six months, researchers measured changes in breast density using mammogram software. The goal was to see if the drug could safely reduce density compared to a placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- (Z)-endoxifen
- What this could lead to
- If successful, this could lead to a non-surgical option to reduce breast density and potentially lower breast cancer risk in premenopausal women.
- What could go wrong
- This is a phase 2 study with 240 participants, so results are still early. The drug may not significantly reduce density or could cause side effects like hot flashes or blood clots.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
240 people
The number who actually took part.
- Started
-
Dec 2021
- Finished
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Mar 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 55 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Premenopausal women (defined as having at least one menstruation during the prior 12 months; women with an intrauterine device are considered premenopausal if \<52 years) 2. Women of childbearing potential using a highly effective method of birth control\* throughout the study period and willing to comply with monthly pregnancy testing 3. Screening mammogram performed within 3 month of study inclusion 4. Mammographic density assessed as BI-RADS® score B, C, or D 5. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects Exclusion Criteria: 1. Mammographic BI-RADS® malignancy code ≥3 at baseline mammography 2. Any previous diagnosis of breast cancer, including carcinoma in situ, or any other cancer (non-melanoma skin cancer and in situ cancer of the cervix are not exclusion criteria) 3. A history of breast surgery, e.g., reduction or enlargement, which might affect mammographic density measurements 4. Current medical conditions: 1. APC (activated protein C) resistance, an inherited coagulation disorder 2. Systolic pressure higher than 160 mm Hg or diastolic higher than 100 mm Hg 3. Cataract(s) 4. Uncontrolled diabetes (defined as HbA1c \>50 mmol/mol) 5. Abnormal lab values deemed clinically significant by Investigator 5. BMI \> 30 6. Women who have an increased risk of venous thrombosis due to immobilization, e.g., using wheelchair 7. Agents that have the potential to decrease endoxifen levels through increased metabolic clearance: 1. Certain anti-epileptic therapies (carbamazepine, fenytoin, fenobarbital, lamotrigine) 2. Certain antibiotics (rifamycins) 3. St John's wort (in Swedish: johannesört) 4. Certain HIV medications (efavirenz, ritonavir) 8. Lactating, pregnant, or plan to become pregnant in the next year 9. History of thromboembolic disease such as embolus, deep vein thrombosis, stroke, TIA (transient ischemic attack) or myocardial infarction 10. Allergy to endoxifen or any of its components 11. Previous treatment with an anti-oestrogen, including experimental drug studies (e.g., Karma CREME, Karisma-1 or Karisma-2) 12. Prescribed and regular use of anticoagulants (defined as substances included in group B01A in the ATC-system) 13. Participation in another investigational clinical trial in the last 6 months 14. Not willing or able to understand the study information and/or informed consent
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Karma Study Centre
Stockholm, Sweden
More trials for these conditions
Other studies related to the condition(s) this trial covers.