Low Dose Exemestane vs Low Dose Tamoxifen in Post-menopausal Women at High Risk for Breast Cancer.

What this trial studies

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 in scope

• Breast Cancer

Interventions

• Tamoxifen 10 MG (Drug) — Blinded tamoxifen 10 mg every other day
• Exemestane 25 MG (Drug) — Blinded exemestane 25 mg every other day

Who can join

Women only · Adults (Child, Adult, Older Adult)

Inclusion 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 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:
• 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:
• 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 for breast and endometrial are eligible.

Exclusion criteria

• 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.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: PHASE2
• Start date: 2025-10-01
• Primary completion: 2027-01-31
• Last update posted: 2025-11-18
• First posted: 2024-04-15

Sponsor & contact

Lead sponsor: Andrea DeCensi (Other)

Collaborators: Dana-Farber/Brigham and Women's Cancer Center, Herbert Irving Comprehensive Cancer Center, Istituto Europeo di Oncologia, Breast Cancer Research Foundation

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Quality of life MEnQol (12 months)
  The primary endpoint is the difference between arms in the score of overall domain of MENQOL after 12 months of treatment.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.