NCT04568616 (NAOMI) is a Phase 2 clinical trial of Letrozole 2.5mg in Breast Cancer, sponsored by Dartmouth-Hitchcock Medical Center.

Who is sponsoring NCT04568616?

NCT04568616 is sponsored by Dartmouth-Hitchcock Medical Center.

What drugs are being tested in NCT04568616?

Interventions in NCT04568616: Letrozole 2.5mg.

What condition does NCT04568616 study?

NCT04568616 studies Breast Cancer, ER Positive Breast Cancer.

Is NCT04568616 still recruiting?

NCT04568616 is currently active, enrolled. Last updated 20 January 2026.

Last reviewed 2026-01-20 · How we verify

NCT04568616: NAOMI

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled Phase 2 Last updated 20 January 2026

What this trial tests

Phase 2 trial testing Letrozole 2.5mg in Breast Cancer in 178 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

13 August 2021

Primary endpoint
2 April 2025

13 August 2029

Quick facts

Lead sponsor	Dartmouth-Hitchcock Medical Center
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	178
Start date	13 August 2021
Primary completion	2 April 2025
Estimated completion	13 August 2029
Sites	2 locations across United States

Drugs / interventions tested

Letrozole 2.5mg (letrozole-2-5mg) — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →
ER Positive Breast Cancer — all drugs for ER Positive Breast Cancer →

Sponsor

Dartmouth-Hitchcock Medical Center

Who can join

18 and older, female only, with Breast Cancer or ER Positive Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Role of mitochondria in physiological activities, diseases, and therapy.
Wang L, Zhou X, Lu T. · · 2025 · cited 23× · PMID 40536597 · DOI 10.1186/s43556-025-00284-5
Oxidative Phosphorylation Is a Metabolic Vulnerability of Endocrine Therapy-Tolerant Persister Cells in ER+ Breast Cancer.
Tau S, Chamberlin MD, Yang H, Marotti JD, et al · · 2025 · cited 16× · PMID 39777474 · DOI 10.1158/0008-5472.can-24-1204
Endocrine persistence in ER+ breast cancer is accompanied by metabolic vulnerability in oxidative phosphorylation
Tau S, Chamberlin MD, Yang H, Marotti JD, et al · · 2024 · DOI 10.1101/2024.09.26.615177

Verify or expand the search:

Other trials of Letrozole 2.5mg

Trials testing the same drug.

NCT07109947 — Use of Aromatase Inhibitor Before Misoprostol in Medical Termination of Miscarriage · NA · recruiting
NCT07285382 — Different Doses of Dalpicicl Combined With Letrozole in the First-line Treatment of HR-positive, HER2-negative Advanced · Phase 2 · recruiting
NCT06143631 — Prescription of Letrozole for Uterine Myoma · Phase 4 · recruiting
NCT06405243 — Myoinositol, L-arginine and Chromium With Letrozole for Ovulation Induction in Polycystic Ovarian Syndrome Patients · Phase 3 · not yet recruiting
NCT06507332 — Combination Letrozole and Clomiphene Citrate Versus Letrozole Alone · NA · unknown

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting

Other Dartmouth-Hitchcock Medical Center trials

Trials by the same sponsor.

NCT07325474 — Plan and Protect: Safety Planning for Teens in Rural Emergency Departments · NA · not yet recruiting
NCT07428629 — Piloting an Insomnia Treatment in Patients With Ulcerative Colitis · NA · not yet recruiting
NCT06777511 — Advancing Antimicrobial Photodynamic Therapy to Prevent Infection in Osseointegrated Prosthesis Patients · not yet recruiting
NCT07279116 — ABY-029 Head & Neck Trial · Phase 1 · not yet recruiting
NCT07063693 — ABY-029 Glioma Trial · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04568616 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center
Last refreshed: 20 January 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04568616.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing