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Compares treatment options for Breast Cancer
Official title Low Dose Exemestane vs Low Dose Tamoxifen in Post-menopausal Women at High Risk for Breast Cancer.
ClinicalTrials.gov ID: NCT06364267
What this study is testing
What is Tamoxifen 10 MG?
Tamoxifen 10 MG is an investigational medicine, given as a monthly pill taken by mouth, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults, women only
You may be able to join if
- Postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in...
- Recent (within 12 months from date of consent form signature) histologic diagnosis of ER+ve (\>5%) DCIS (patients with DCIS should have undergone...
- 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...
- Known carriers of a germline pathogenic/likely pathogenetic variant in the following moderate penetrance genes (CHEK2 or ATM), or women with chest...
- Eastern Cooperative Oncology Group - Performance Status (ECOG-PS) 0-1.
You likely can't join if
- Pre/perimenopausal women
- History of DVT or PE.
- Endometrial cancer.
- Macular disorders.
- Inability to comply with study procedures.
- Prior use of antiestrogens within 12 months from the date of the trial consent form signature.
See the full eligibility criteria
- 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...
- 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...
- 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 how well it works assessment of the investigational regimen are eligible...
- Ability to understand and the willingness to sign a written informed consent document.
- Mammography performed up to 6 months before the trial consent form signature.
- DEXA performed up to 12 months before the trial consent form signature.
- Patients with life expectancy ≥ 10 years.
- Patients with normal liver function tests and blood cell count.
- Negative gynaecological examination performed up to 6 months before the trial consent form signature.
- Pre/perimenopausal women
- History of DVT or PE.
- Endometrial cancer.
- Macular disorders.
- Inability to comply with study procedures.
- Prior use of antiestrogens within 12 months from the date of the trial consent form signature.
- Use of hormone replacement therapy (HRT) within 3 months from the date of the trial consent form signature.
- 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.
- Use of terbinafine, quinidine, cinacalcet, rifampicin, phenytonin, carbamazepine, phenobarbital, and St. John's wort, warfarin, erythromycin, cyclosporin, nifepidine and any concomitant coumarin-type anticoagulant...
- Patients with moderate or severe renal impairment.
- Patients with a known hypersensitivity to study drugs.
The study team makes the final eligibility decision.
Where it's taking place
- Genova, Italy, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Genova, Italy, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.