NCT06364267 Low Dose Exemestane vs Low Dose Tamoxifen in Post-menopausal Women at High Risk for Breast Cancer.
| NCT ID | NCT06364267 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Andrea DeCensi |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 140 participants in total. It began in 2025-10-01 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Postmenopausal state is defined 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. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Any of the following criteria must be met: 1. 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) or diagnosis within 3 years of HRL (ADH, LCIS, ALH), or: 2. 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: 3. 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. 2. Eastern Cooperative Oncology Group - Performance Status (ECOG-PS) 0-1. 3. Able to swallow oral medications. 4. 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 for breast and endometrial are eligible. 5. Ability to understand and the willingness to sign a written informed consent document. 6. Mammography performed up to 6 months before the trial consent form signature. 7. DEXA performed up to 12 months before the trial consent form signature. 8. Patients with life expectancy ≥ 10 years. 9. Patients with normal liver function tests and blood cell count. 10. Negative gynaecological examination performed up to 6 months before the trial consent form signature. Exclusion Criteria: 1. Pre/perimenopausal women 2. History of DVT or PE. 3. Endometrial cancer. 4. Macular disorders. 5. Inability to comply with study procedures. 6. Prior use of antiestrogens within 12 months from the date of the trial consent form signature. 7. Use of hormone replacement therapy (HRT) within 3 months from the date of the trial consent form signature. 8. Severe osteoporosis (T score ≤ 2.5 at either spine or hip), or recent vertebral fracture (within 6 months) not treated with zolendronic acid or denosumab. 9. Use of terbinafine, quinidine, cinacalcet, rifampicin, phenytonin, carbamazepine, phenobarbital, and St. John's wort, warfarin, erythromycin, cyclosporin, nifepidine and any concomitant coumarin-type anticoagulant therapy. 10. Patients with moderate or severe renal impairment. 11. Patients with a known hypersensitivity to study drugs.
Contact & Investigator
Andrea U De Censi, MD
STUDY CHAIR
Ente Ospedaliero Ospedali Galliera
Frequently Asked Questions
Who can join the NCT06364267 clinical trial?
This trial is open to female participants only, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06364267 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06364267 currently recruiting?
Yes, NCT06364267 is actively recruiting participants. Contact the research team at andrea.decensi@galliera.it for enrollment information.
Where is the NCT06364267 trial being conducted?
This trial is being conducted at Genova, Italy.
Who is sponsoring the NCT06364267 clinical trial?
NCT06364267 is sponsored by Andrea DeCensi. The principal investigator is Andrea U De Censi, MD at Ente Ospedaliero Ospedali Galliera. The trial plans to enroll 140 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.