Randomized Double-Blind Phase II Trial of Baby Exemestane Versus Baby Tamoxifen in Post-Menopausa… (NCT07499999) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Randomized Double-Blind Phase II Trial of Baby Exemestane Versus Baby Tamoxifen in Post-Menopausal Women at High Risk for Breast Cancer
United States140 participantsStarted 2026-09-09
Plain-language summary
The goal of this research study is to evaluate the efficacy and safety of low-dose exemestane versus low-dose tamoxifen in post-menopausal women at high risk for breast cancer.
The names of the study drugs involved in this study are:
* Exemestane (a type of steroidal aromatase inhibitor)
* Tamoxifen (a type of selective estrogen receptor modulator)
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 state is defined⁸ as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy.
* Any of the following criteria must be met:
* Recent (within 12 months from date of consent form signature) histologic diagnosis of ER+ve (\>5%) DCIS (patients with DCIS should have undergone breast-conserving therapy i.e. lumpectomy to remove the tumor with negative surgical margins followed by radiotherapy (see footnote 1 below)) diagnosis within 3 years of HRL (ADH, LCIS, ALH), or;
* At least 3% breast cancer risk at 5 years (or 5% risk at 10yrs) per one of the following risk models: the Breast Cancer Surveillance Consortium risk calculator V3 or Tyrer-Cuzick model V8 or;
* Known carriers of a germline pathogenic/likely pathogenetic variant in the following moderate penetrance genes (CHEK2 or ATM), or women with chest wall irradiation before age of 30 years
* Eastern Cooperative Oncology Group - Performance Status (ECOG-PS) 0-1
* Able to swallow oral medications
* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Specifically, all cancers diagnosed since 3 years or longer except …
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.
1This trial is comparing low-dose ('baby') exemestane to low-dose ('baby') tamoxifen for people at high risk of breast cancer — given my specific risk factors, like my gene mutation or atypical cell findings, which of these two medications might be a better fit for me to discuss?
2Since this is a Phase II trial that hasn't started enrolling yet, what does that mean for my timeline — should I consider starting a standard-dose prevention medication now, or is it worth waiting to see if this trial opens near me?
3The trial's main goal is measuring quality of life at 12 months using a menopause-specific questionnaire, not tumor prevention directly — does that mean we don't yet have strong evidence that these lower doses actually reduce my breast cancer risk the way full doses do?
4Because this is a randomized double-blind study, I wouldn't know which medication I'm receiving — how would you monitor me for side effects if neither of us knows my assignment, and what are the known side effect profiles of both exemestane and tamoxifen that I should be aware of?
5Given that I'm post-menopausal, how does my overall health profile, including any bone density or cardiovascular concerns, factor into whether exemestane or tamoxifen would be safer for me to take, even at these lower 'baby' doses?
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
Difference in Overall Domain Score Change From Baseline in Menopause-Specific Quality of Life Questionnaire (MENQOL) Between the Two Arms at 12 Months