Effect of Metformin on Endometrial Thickness in Postmenopausal Breast Cancer Patients Receiving T… (NCT07145827) | Clinical Trial Compass
CompletedNot Applicable
Effect of Metformin on Endometrial Thickness in Postmenopausal Breast Cancer Patients Receiving Tamoxifen
Iraq60 participantsStarted 2024-01-02
Plain-language summary
The goal of this clinical trial is to learn if metformin can reduce the increase in endometrial thickness caused by tamoxifen in women with estrogen-positive breast cancer taking tamoxifen for more than 1 year. It will also learn about the safety of taking metformin with tamoxifen. The main questions it aims to answer are:
1. Does metformin decrease endometrial thickness in women receiving tamoxifen?
2. What medical problems do participants have when taking metformin with tamoxifen?
Researchers will compare tamoxifen plus metformin to tamoxifen plus placebo to see if metformin works to reduce endometrial thickness compared to placebo patients.
Participants will:
1. Take metformin daily along with tamoxifen, or take tamoxifen with placebo.
2. Acquire baseline assessment and then visit the clinic at 3 months, 6 months, 9 months and 12 months for checkups and trans abdominal ultrasound test for endometrial thickness, and to be monitored for any side effects or complications.
Who can participate
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:
* Postmenopausal Female patients (amenorrhea ≥ 12 months).
* Histologically proven (Estrogen-positive) breast cancer.
* Completed all required surgery and/or chemotherapy (if indicated)
* On adjuvant tamoxifen for at least 1 year.
* Accepts to enroll in the study
Exclusion Criteria:
* Refusing to enroll in the study
* Ongoing or History of: endometrial or ovarian malignancy
* Concurrent hormonal therapy that might affect endometrial thickness
* Concurrent Diabetes mellitus in which metformin is prescribed.
* Known hypersensitivity or severe intolerance to metformin
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 in endometrial thickness
Timeframe: Baseline, 3 months, 6 months, 9 months, and 12 months from enrollment