Effect of Oral (Z)-Endoxifen in Premenopausal Women With Measurable Breast Density (NCT05068388) | Clinical Trial Compass
CompletedPhase 2
Effect of Oral (Z)-Endoxifen in Premenopausal Women With Measurable Breast Density
Sweden240 participantsStarted 2021-12-21
Plain-language summary
This is a randomized, double-blinded, placebo-controlled dose-response efficacy study of oral (Z)-endoxifen in premenopausal women with measurable breast density. There will be 5 in-clinic visits (Screening, Day 1, Months 1, 3 and 6) and 3 self-report visits (Months 2, 4 and 5). Standard of care mammograms will be used for the screening mammogram as well as the 24-month follow up visit.
Who can participate
Age range
40 Years – 55 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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)
. Women of childbearing potential using a highly effective method of birth control\* throughout the study period and willing to comply with monthly pregnancy testing
. Screening mammogram performed within 3 month of study inclusion
. Mammographic density assessed as BI-RADS® score B, C, or D
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change of mammographic density area (cm2) assessed by iCAD® software
. Mammographic BI-RADS® malignancy code ≥3 at baseline mammography
. 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)
. A history of breast surgery, e.g., reduction or enlargement, which might affect mammographic density measurements
. Current medical conditions:
. APC (activated protein C) resistance, an inherited coagulation disorder
. Systolic pressure higher than 160 mm Hg or diastolic higher than 100 mm Hg
. Cataract(s)
. Uncontrolled diabetes (defined as HbA1c \>50 mmol/mol)