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

Study acronym: BabyTears
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 1, 2025 to Oct 1, 2025
    • Site details revised
    v6
  2. Start date: Apr 1, 2025 to Sep 1, 2025v5
  3. Start date: Feb 1, 2025 to Apr 1, 2025
    • Secondary endpoints: 9 to 10
    • Site details revised
    v4
  4. Start date: Sep 1, 2024 to Feb 1, 2025v3 Show 6 more changesShow less
    • Enrollment target: 160 to 140
    • Primary and study completion dates: Sep 1, 2026 to Jan 31, 2027
    • Eligibility criteria shortened, about 59 words
    • Secondary endpoints: 7 to 9
    • Study description shortened, about 8 words
    • Study title revised
  5. Study title expanded, about 4 wordsv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06364267
Lead Sponsor Andrea DeCensi
Collaborators: Dana-Farber/Brigham and Women's Cancer Center, Herbert Irving Comprehensive Cancer Center, Istituto Europeo di Oncologia, Breast Cancer Research Foundation
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov