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Window of Opportunity Study Targeting the Inflammatory Milieu

NCT01881048 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-01-29

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effect of two anti-inflammatory drugs, fish oil capsules and the COX-2 inhibitor celecoxib, on pregnancy associated breast cancer (PABC). Short-term intervention with anti-inflammatory medications will demonstrate a reduction in the inflammation and immune suppressive phenotype of PABC, and decreased metastatic potential in PABC. This unique window in breast cancer management serves as a valuable opportunity to obtain preliminary data on biomarkers and the alterations that occur when the system is troubled by a drug or other intervention which will be instrumental in designing future therapeutic or preventative strategies for larger clinical study.

Conditions

  • Stage IA Breast Cancer
  • Stage IB Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer

Interventions

DIETARY_SUPPLEMENT

Omega-3 fatty acid

Given PO

DRUG

Celecoxib

Given PO

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Virginia Borges, MD, MSc · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-08
Primary Completion
2014-01-14
Completion
2015-12-14

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01881048 on ClinicalTrials.gov