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COX-2 Inhibitor

Omega-3 fatty acid + Celecoxib for Breast Cancer

Phase < 1
Waitlist Available
Led By Virginia Borges, MD, MSc
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histological or cytological confirmation of breast cancer; for patients with fine needle aspiration (FNA), a core biopsy must be intended
Any clinical stage allowed provided definitive local resection intended and neoadjuvant treatment not intended
Must not have
Known allergy or intolerance to fish oil, fish, non-steroidal anti-inflammatory drugs (NSAIDS), acetylsalicylic acid (ASA) or cyclooxygenase-2 (COX 2) inhibitors
Any previous diagnosis of breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 1 week
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at whether anti-inflammatory drugs can help reduce the risk of PABC and improve outcomes.

Who is the study for?
This trial is for breast cancer patients with normal organ function, an ECOG performance status of 0-1, and a platelet count within the normal range. They must be willing to avoid fish oil or celecoxib if assigned to the control group and agree to surgery at least one week after diagnosis. Exclusions include history of stroke or heart disease, current high-dose fish oil or celecoxib use unless they stop prior to the study, pregnancy intending to continue, autoimmune conditions, chronic steroid use, psychiatric issues affecting compliance, previous cancers except breast cancer treated over 5 years ago.
What is being tested?
The study tests whether short-term treatment with anti-inflammatory drugs (fish oil capsules and COX-2 inhibitor celecoxib) can reduce inflammation and immune suppression in pregnancy-associated breast cancer (PABC), potentially decreasing its ability to spread. The goal is also to gather data on biomarkers affected by these interventions.
What are the potential side effects?
Potential side effects may include allergic reactions for those sensitive to fish oil or NSAIDs like Celecoxib; digestive issues such as stomach ulcers; increased risk of bleeding; and possibly changes in liver enzymes due to drug metabolism.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer diagnosis was confirmed through a biopsy.
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My cancer can be surgically removed and I am not planned for pre-surgery treatment.
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I am fully active or can carry out light work.
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My anemia is not severe.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am allergic to fish, NSAIDs, ASA, or COX 2 inhibitors.
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I have been diagnosed with breast cancer before.
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I have an autoimmune condition or take medication that affects my immune system.
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I don't have bleeding disorders or a history of stomach ulcers, but controlled acid reflux is okay.
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I have had a stroke, TIA, or coronary artery disease.
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I do not have conditions like severe diabetes, COPD, uncontrolled infections, or HIV.
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I have had Hodgkin's disease treated with a specific type of radiation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 1 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 1 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in mean Ki-67 index in patients receiving either omega-3 fatty acid or celecoxib for 1 or more weeks as compared to controls

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm III (celecoxib)Experimental Treatment1 Intervention
Patients receive celecoxib by mouth twice a day until the morning of surgery.
Group II: Arm II (fish oil)Experimental Treatment1 Intervention
Patients receive omega-3 fatty acid by mouth everyday until the morning of surgery.
Group III: Arm IActive Control1 Intervention
Patients undergo observation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omega-3 fatty acid
2010
Completed Phase 4
~640
Celecoxib
2019
Completed Phase 4
~1740

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,804 Previous Clinical Trials
2,822,124 Total Patients Enrolled
30 Trials studying Breast Cancer
6,889 Patients Enrolled for Breast Cancer
Virginia Borges, MD, MScPrincipal InvestigatorUniversity of Colorado, Denver

Media Library

Celecoxib (COX-2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01881048 — Phase < 1
Breast Cancer Research Study Groups: Arm I, Arm II (fish oil), Arm III (celecoxib)
Breast Cancer Clinical Trial 2023: Celecoxib Highlights & Side Effects. Trial Name: NCT01881048 — Phase < 1
Celecoxib (COX-2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01881048 — Phase < 1
~3 spots leftby Nov 2025
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