Actively Recruiting
Low Dose Exemestane vs Low Dose Tamoxifen in Post-menopausal Women at High Risk for Breast Cancer.
Led by Andrea DeCensi · Updated on 2025-11-18
140
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
Sponsors
A
Andrea DeCensi
Lead Sponsor
D
Dana-Farber/Brigham and Women's Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of the study is to to compare low dose of exemestane (babyexe) versus low dose of tamoxifen (babytam) in terms of change of quality of life from baseline to 12 months.
CONDITIONS
Official Title
Low Dose Exemestane vs Low Dose Tamoxifen in Post-menopausal Women at High Risk for Breast Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Postmenopausal women defined by no menstrual periods for 12 months or permanent sterilization
- Recent diagnosis (within 12 months) of ER-positive DCIS treated with breast-conserving therapy and radiotherapy, or diagnosis within 3 years of specific high-risk breast lesions
- At least 3% breast cancer risk at 5 years or 5% risk at 10 years by approved risk models
- Known carriers of specific genetic variants or history of chest wall irradiation before age 30
- Eastern Cooperative Oncology Group performance status 0-1
- Ability to swallow oral medications
- Prior or concurrent malignancies allowed if diagnosed 3 or more years ago except breast and endometrial cancers
- Willingness and ability to sign informed consent
- Mammography within 6 months before consent
- DEXA scan within 12 months before consent
- Life expectancy of 10 years or more
- Normal liver function and blood cell count
- Negative gynecological examination within 6 months before consent
You will not qualify if you...
- Pre- or perimenopausal women
- History of deep vein thrombosis or pulmonary embolism
- Endometrial cancer
- Macular disorders
- Inability to comply with study procedures
- Use of antiestrogens within 12 months before consent
- Use of hormone replacement therapy within 3 months before consent
- Severe osteoporosis (T score ≤ -2.5 at spine or hip) or recent untreated vertebral fracture within 6 months
- Use of certain medications including terbinafine, quinidine, rifampicin, phenytoin, carbamazepine, phenobarbital, St. John's wort, warfarin, erythromycin, cyclosporin, nifedipine, and coumarin-type anticoagulants
- Moderate or severe kidney impairment
- Known hypersensitivity to study drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
E.O. Ospedali Galliera
Genova, Italy, Italy, 16128
Actively Recruiting
Research Team
A
Andrea U De Censi, MD
CONTACT
D
Davide S Corradengo, SC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here