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Phase II Study of Neoadjuvant ArOMatase Inhibitor Therapy for ER+ Breast Cancer (NAOMI)

Study acronym: NAOMI
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion pushed from Apr 2, 2025 to Apr 2, 2028v11
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 137 to confirmed 178
    • Primary completion date changed from estimate of Feb 13, 2026 to Apr 2, 2025
    • Site details revised at 2 of 2 sites
    v10
  3. Primary completion date: Sep 2024 to Feb 13, 2026
    • Study completion date: Sep 2024 to Aug 13, 2029
    v9
  4. Enrollment target: 28 to 137v8 Show 6 more changesShow less
    • Primary endpoints: 1 to 3
    • Eligibility criteria expanded, about 58 words
    • Secondary endpoints: 7 to 8
    • Study description revised
    • Site details revised at 1 of 2 sites
    • Study title expanded, about 4 words
  5. Primary completion date: Sep 2023 to Sep 2024v7
Show 5 earlier versionsHide 5 earlier versions
  1. Re-verified, no change to tracked fieldsv6
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2021 to Aug 13, 2021
    • Site details revised at 2 of 2 sites
    v5
  3. Start date: Jun 2021 to Sep 2021
    • Primary completion date: Jun 2023 to Sep 2023
    • Study completion date: Jun 2024 to Sep 2024
    v4
  4. Start date: Mar 2021 to Jun 2021
    • Primary completion date: Mar 2023 to Jun 2023
    • Study completion date: Mar 2024 to Jun 2024
    v3
  5. Start date: Nov 2020 to Mar 2021v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a single-arm, open-label study testing the effects of neoadjuvant therapy with the aromatase inhibitor letrozole in post-menopausal women with Stage I-III ER+, HER2- breast cancer. Eligible subjects will be treated with letrozole therapy for 4 to 24 weeks prior to surgical resection of the tumor. Tumor specimens obtained at baseline (diagnostic biopsy) and at surgery (surgical specimen) will be compared using molecular analyses. A subset of subjects will be asked to provide an optional research tumor biopsy prior to treatment for molecular analysis. Subjects will be evaluated for treatment adherence and provide feedback via survey questionnaires to identify potential causes of non-adherence.
Trial Details
NCT Number NCT04568616
Lead Sponsor Dartmouth-Hitchcock Medical Center
Conditions
(from sponsor)		 Breast Cancer, ER Positive Breast Cancer
Related terms Breast Neoplasms
Enrollment 178 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov