NCT04038489 (Breast 51) is a Phase 2 clinical trial of Aspirin in Breast Cancer, sponsored by University of Virginia.

Who is sponsoring NCT04038489?

NCT04038489 is sponsored by University of Virginia.

What drugs are being tested in NCT04038489?

Interventions in NCT04038489: Aspirin, Tamoxifen Pill, Doxorubicin, Cyclophosphamide, Paclitaxel.

What condition does NCT04038489 study?

NCT04038489 studies Breast Cancer, Estrogen Receptor-positive Breast Cancer.

Is NCT04038489 still recruiting?

NCT04038489 is currently withdrawn. Last updated 22 November 2021.

Last reviewed 2021-11-22 · How we verify

NCT04038489: Breast 51

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

COX Inhibition and Biomarkers During Neoadjuvant Chemoendocrine Therapy for ER+, HER2- Stage I-III Breast Cancer

Withdrawn Phase 2 Last updated 22 November 2021

What this trial tests

Phase 2 trial testing Aspirin in Breast Cancer. Withdrawn.

Timeline

18 October 2019

Primary endpoint
30 April 2023

30 April 2023

Quick facts

Lead sponsor	University of Virginia
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	18 October 2019
Primary completion	30 April 2023
Estimated completion	30 April 2023
Sites	1 location across United States

Drugs / interventions tested

Aspirin
Tamoxifen Pill — full drug profile →
Doxorubicin (doxorubicin) — full drug profile →
Cyclophosphamide (cyclophosphamide) — full drug profile →
Paclitaxel — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →
Estrogen Receptor-positive Breast Cancer — all drugs for Estrogen Receptor-positive Breast Cancer →

Sponsor

University of Virginia

Who can join

18 and older, any sex, with Breast Cancer or Estrogen Receptor-positive Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is designed to assess the safety and clinical activity of tamoxifen and the COX inhibitor, aspirin, given in combination with standard AC-T chemotherapy (doxorubicin, cyclophosphamide, and paclitaxel) for the treatment of high-risk estrogen receptor (ER)+, human epidermal growth factor receptor 2 (HER2)- breast cancer. If successful, the study could improve long-term outcomes for a subpopulation of women with aggressive stage I-III ER+/HER2- breast cancer.

Publications & conference data

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

Lipid metabolic reprogramming in tumor microenvironment: from mechanisms to therapeutics.
Jin HR, Wang J, Wang ZJ, Xi MJ, et al · · 2023 · cited 284× · PMID 37700339 · DOI 10.1186/s13045-023-01498-2
Cellular Metabolomics Profiles Associated With Drug Chemosensitivity in AML.
Stockard B, Bhise N, Shin M, Guingab-Cagmat J, et al · · 2021 · cited 13× · PMID 34178663 · DOI 10.3389/fonc.2021.678008

Verify or expand the search:

Other trials of Aspirin

Trials testing the same drug.

NCT07525635 — Aspirin Dosing in Pregnancy · EARLY_PHASE1 · not yet recruiting
NCT07431762 — Comparison of Anti-Thrombotic Treatments Between Aspirin and Warfarin During Initial Six Months After Bioprpsthetic Hear · Phase 4 · not yet recruiting
NCT07373756 — Randomized Controlled Study to Compare Efficacy of Aspirin 75mg and 150mg In the Prevention of Preeclampsia In High Risk · Phase 4 · not yet recruiting
NCT07180472 — Prevention of Stroke Recurrence and Disease Progression in Cerebral Small Vessel Disease With Cilostazol · Phase 4 · not yet recruiting
NCT06638151 — Clopidogrel Plus Aspirin in Acute Ischemic Stroke Following Thrombectomy and/or Intravenous Thrombolysis (CoPrime) · Phase 2 · recruiting

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 University of Virginia trials

Trials by the same sponsor.

NCT05880355 — Multimodality Cardiovascular Imaging for the Translation of Therapies for Vascular Activation After MI · EARLY_PHASE1 · not yet recruiting
NCT07405645 — Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy · NA · recruiting
NCT07146685 — Effect of Local Anesthetic Concentration on Rebound Pain: A Randomized Control Study · Phase 4 · not yet recruiting
NCT07298941 — Resilience Enhancement Following Sleep Treatment · Phase 2 · recruiting
NCT07036315 — Meaning in Music-Based Pain Modulation · NA · 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 NCT04038489 (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 University of Virginia
Last refreshed: 22 November 2021

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/NCT04038489.

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