NCT04268134 (ALTA) is a Phase 2 clinical trial of Omega-3 fatty acid supplement in Breast Cancer, sponsored by University of Michigan Rogel Cancer Center.

Who is sponsoring NCT04268134?

NCT04268134 is sponsored by University of Michigan Rogel Cancer Center.

What drugs are being tested in NCT04268134?

Interventions in NCT04268134: Omega-3 fatty acid supplement.

What condition does NCT04268134 study?

NCT04268134 studies Breast Cancer.

Is NCT04268134 still recruiting?

NCT04268134 is currently completed. Last updated 29 February 2024.

Last reviewed 2024-02-29 · How we verify

NCT04268134: ALTA

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

Altering Lipids for Tolerance of Aromatase Inhibitor Therapy

Completed Phase 2 Last updated 29 February 2024

What this trial tests

Phase 2 trial testing Omega-3 fatty acid supplement in Breast Cancer in 77 participants. Completed in 27 February 2024.

Timeline

28 July 2020

Primary endpoint
27 February 2024

27 February 2024

Quick facts

Lead sponsor	University of Michigan Rogel Cancer Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	77
Start date	28 July 2020
Primary completion	27 February 2024
Estimated completion	27 February 2024
Sites	1 location across United States

Drugs / interventions tested

Omega-3 fatty acid supplement — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →

Sponsor

University of Michigan Rogel Cancer Center

Who can join

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

Sponsor's own description

Aromatase inhibitor medications have been approved by the U.S Food and Drug Administration (FDA) for treatment of hormone receptor positive breast cancer. This treatment has been shown to be very effective for treating breast cancer. However, some patients have difficulty tolerating the treatment, and some even decide to stop treatment because of the side effects. Research has shown that over half of patients who had joint pain and stiffness when taking an aromatase inhibitor had an improvement in their symptoms when they took omega-3 fatty acid supplements. This study is being conducted to test whether having patients start to take an omega-3 fatty acid supplement soon after they starting taking an aromatase inhibitor medicine will reduce the likelihood that they will have bothersome symptoms.

Publications & conference data

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

Reprogramming of Lipid Metabolism Mediates Crosstalk, Remodeling, and Intervention of Microenvironment Components in Breast Cancer.
Wang J, Zhang W, Liu C, Wang L, et al · · 2024 · cited 30× · PMID 38481820 · DOI 10.7150/ijbs.92125
Contribution of n-3 Long-Chain Polyunsaturated Fatty Acids to the Prevention of Breast Cancer Risk Factors.
Fodil M, Blanckaert V, Ulmann L, Mimouni V, et al · · 2022 · cited 13× · PMID 35805595 · DOI 10.3390/ijerph19137936
Dysregulation of Fatty Acid Metabolism in Breast Cancer and Its Targeted Therapy.
Chang Y, Du R, Xia F, Xu X, et al · · 2024 · cited 5× · PMID 39628960 · DOI 10.2147/bctt.s496322
Dynamic Evolution of the Tumor Immune Microenvironment in Malignant Tumors and Emerging Therapeutic Paradigms.
Sun Y, Shao C, Duan H, Wang Z, et al · · 2025 · cited 1× · PMID 41346571 · DOI 10.1002/mco2.70496

Verify or expand the search:

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 Michigan Rogel Cancer Center trials

Trials by the same sponsor.

NCT06914479 — Virus-Based Gene Therapy (AdV-HSV1-TK and AdV-Flt3L) in Combination With Valacyclovir for the Treatment of Pediatric and · Phase 1 · recruiting
NCT07481344 — SunBeast: Evaluating UV Protective Behaviors and Education Interventions Among Ultrarunners · NA · not yet recruiting
NCT07526545 — Urine Prostate Screening Integrated With MRI for Early Detection of Prostate Cancer, UPRISE Trial · NA · not yet recruiting
NCT07443943 — A Dietary Supplement (Resistant Potato Starch) for Reducing Musculoskeletal Symptoms in Individuals Planning to Receive · Phase 2 · recruiting
NCT07365007 — A Virtually Delivered Diet Intervention (LASO-3) for the Improvement of Chemotherapy-Induced Peripheral Neuropathy in Ca · 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 NCT04268134 (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 Michigan Rogel Cancer Center
Last refreshed: 29 February 2024

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/NCT04268134.

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