RecruitingPhase 2NCT06364267

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

Randomized Double Blind Phase II Trial of Baby Exemestane vs Baby Tamoxifen in Post-menopausal Women at High Risk for Breast Cancer.


Sponsor

Andrea DeCensi

Enrollment

140 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This study compares two low-dose hormone-blocking medications — exemestane and tamoxifen — to see which is more effective at reducing the risk of developing invasive breast cancer in postmenopausal women who are at high risk due to a pre-cancerous breast condition called DCIS (ductal carcinoma in situ) or lobular neoplasia, or due to a strong family history. **You may be eligible if...** - You are postmenopausal (no periods for at least 12 months) - You have been diagnosed with DCIS, lobular neoplasia, or have a strong family history of breast cancer - For DCIS patients: you have had breast-conserving surgery with clear margins - Your estrogen receptor status meets the study's criteria **You may NOT be eligible if...** - You have invasive breast cancer - You have significant bone loss (osteoporosis) or other conditions making hormone therapy unsafe - You are premenopausal Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTamoxifen 10 MG

Blinded tamoxifen 10 mg every other day

DRUGExemestane 25 MG

Blinded exemestane 25 mg every other day


Locations(1)

E.O. Ospedali Galliera

Genova, Italy, Italy

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NCT06364267


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