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Could a daily pill lower breast cancer risk by reducing breast density?

NCT ID NCT05068388

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

40 to 55 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Karma Study Centre

    Stockholm, Sweden

More trials for these conditions

Other studies related to the condition(s) this trial covers.