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

NCT06364267 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-11-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Tamoxifen 10 MG

Blinded tamoxifen 10 mg every other day

DRUG

Exemestane 25 MG

Blinded exemestane 25 mg every other day

Sponsors & Collaborators

  • Dana-Farber/Brigham and Women's Cancer Center

    collaborator OTHER

  • Herbert Irving Comprehensive Cancer Center

    collaborator OTHER

  • Istituto Europeo di Oncologia

    collaborator OTHER

  • Breast Cancer Research Foundation

    collaborator OTHER

  • Andrea DeCensi

    lead OTHER

Principal Investigators

  • Andrea U De Censi, MD · Ente Ospedaliero Ospedali Galliera

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06364267 on ClinicalTrials.gov