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NCT04568616 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Neoadjuvant ArOMatase Inhibitor Therapy for ER+ Breast Cancer (NAOMI)
A Phase 2 study of Breast Cancer and ER Positive Breast Cancer, sponsored by Dartmouth-Hitchcock Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 178
- Enrollment target
- 2
- Study locations
NCT04568616: Active Phase 2 study of Breast Cancer and ER Positive Breast Cancer, sponsored by Dartmouth-Hitchcock Medical Center.
NCT04568616 is a Phase 2 study of Breast Cancer and ER Positive Breast Cancer that is active but no longer recruiting, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 178 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04568616, a Phase 2 study of Breast Cancer and ER Positive Breast Cancer, is active but no longer recruiting, sponsored by Dartmouth-Hitchcock Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 178 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
Determine whether residual cancer cells exhibit upregulation of the fatty acid transport CPT1-alpha (compared to baseline) following neoadjuvant endocrine therapy in patients with ER+ breast cancer.
Conditions Studied
Interventions
- DRUG Letrozole 2.5mg
Study Locations (2)
New Hampshire
- Dartmouth Hitchcock Medical Center - Lebanon
- Dartmouth-Hitchcock Medical Center - Lebanon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 178 participants |
| Start Date | 2021-08-13 |
| Est. Completion | 2029-08-13 |
| Phase | Phase 2 |
What the registry record for NCT04568616 still lists
NCT04568616 is an interventional study that assigns participants to a tested intervention. The registered 178 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Letrozole 2.5mg is the first listed.
NCT04568616 reports a single indexed study location in New Hampshire.
Frequently Asked Questions
What is clinical trial NCT04568616 about?
NCT04568616 is a clinical study titled "Phase II Study of Neoadjuvant ArOMatase Inhibitor Therapy for ER+ Breast Cancer (NAOMI)". 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 t...
What is the current status of trial NCT04568616?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 178 participants. The study started on 2021-08-13. Estimated completion is 2029-08-13.
What conditions does trial NCT04568616 study?
This clinical trial studies the following conditions: Breast Cancer, ER Positive Breast Cancer.
What interventions are being tested in trial NCT04568616?
The interventions under investigation include: Letrozole 2.5mg (DRUG).
Who is sponsoring clinical trial NCT04568616?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04568616 being conducted?
This trial has 2 study locations across New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04568616's enrollment target sits among peer trials
178 410th of 1224 higher than 813 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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