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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04568616
The ClinicalTrials.gov registry entry for NCT04568616 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 178 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (94% lower). The listed sponsor is Dartmouth-Hitchcock Medical Center, which has 427 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 1 distinct geographic area - top geographies include 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.
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