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Window of Opportunity Study Targeting the Inflammatory Milieu

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01881048
Recruitment Status : Active, not recruiting
First Posted : June 19, 2013
Last Update Posted : January 31, 2023
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE June 14, 2013
First Posted Date  ICMJE June 19, 2013
Last Update Posted Date January 31, 2023
Actual Study Start Date  ICMJE December 8, 2009
Actual Primary Completion Date January 14, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2013)
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 [ Time Frame: Baseline and 1 week ]
Tumor cells are stained using the Ki-67 monoclonal antibody. Ki-67 is measured as a percentage of positive tumor cells. The investigator will conduct three paired t-tests comparing the percent Ki-67 at baseline to the percent Ki-67 after treatment. There will be one t-test for each arm.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Window of Opportunity Study Targeting the Inflammatory Milieu
Official Title  ICMJE Window of Opportunity Study Targeting the Inflammatory Milieu of Pregnancy Associated Breast Cancer
Brief 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.
Detailed Description This randomized pilot clinical trial studies omega-3 fatty acid or celecoxib in treating patients with breast cancer planning to undergo surgery. Omega-3 fatty acid may stimulate the immune system in different ways and stop tumor cells from growing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether omega-3 fatty acid or celecoxib is more effective in treating breast cancer.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Dietary Supplement: Omega-3 fatty acid
    Given PO
    Other Name: fish oil, n-3 fatty acid, omega-3 polyunsaturated fatty acid
  • Drug: Celecoxib
    Given PO
    Other Name: Celebrex
Study Arms  ICMJE
  • No Intervention: Arm I
    Patients undergo observation.
  • Experimental: Arm II (fish oil)
    Patients receive omega-3 fatty acid by mouth everyday until the morning of surgery.
    Intervention: Dietary Supplement: Omega-3 fatty acid
  • Experimental: Arm III (celecoxib)
    Patients receive celecoxib by mouth twice a day until the morning of surgery.
    Intervention: Drug: Celecoxib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 5, 2016)
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2013)
Estimated Study Completion Date  ICMJE December 2023
Actual Primary Completion Date January 14, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histological or cytological confirmation of breast cancer; for patients with fine needle aspiration (FNA), a core biopsy must be intended
  • For patients diagnosed with needle core or excisional biopsy, formalin-fixed paraffin embedded tumor blocks or unstained slides must be available or patient must be willing to undergo repeat core biopsy for research purposes as part of study procedures (biopsy for fresh/ fresh frozen tissue is otherwise optional)
  • Any clinical stage allowed provided definitive local resection intended and neoadjuvant treatment not intended
  • Patient must be planned to proceed to definitive surgery for their breast cancer at least 1 week or more after diagnosis
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Total bilirubin =< 2 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) =< 2 x ULN
  • Alanine aminotransferase (ALT) =< 2 x ULN
  • Alkaline phosphatase =< 2 x ULN
  • Normal serum creatinine
  • Platelet count greater than or equal to institutional lower limit of normal (LLN)
  • Patient cannot have greater than grade 1 anemia as determined by hematocrit (Hct)
  • Written informed consent obtained prior to any initiation of study procedures
  • Willingness to abstain from either fish oil or celebrex for study period if randomized to control arm
  • Women who are lactating at time of diagnosis are eligible provided they complete weaning prior to starting study drug

Exclusion Criteria:

  • Known autoimmune condition, chronic steroid use, underlying immune disease (other than breast cancer), use of immunomodulatory prescription drugs for any medical condition
  • Known allergy or intolerance to fish oil, fish, non-steroidal anti-inflammatory drugs (NSAIDS), acetylsalicylic acid (ASA) or cyclooxygenase-2 (COX 2) inhibitors
  • Known bleeding diathesis or history of peptic ulcer disease; gastroesophageal reflux allowed if controlled
  • Currently taking greater than one 1000mg fish oil capsule daily or celecoxib at baseline, unless willing to stop consumption 1 week prior to starting study
  • History of stroke, transient ischemic attack (TIA) or coronary artery disease
  • The presence of other comorbid conditions known to impact immune function, (such as: type I diabetes, uncontrolled adult onset diabetes, severe chronic obstructive pulmonary disease (COPD), uncontrolled infection or known human immunodeficiency virus [HIV] infection)
  • Underlying psychiatric condition which would, in the opinion of the investigator, preclude compliance with study requirements
  • Women who are pregnant at time of breast cancer diagnosis and intend to continue the pregnancy; if pregnancy is terminated per patient's cancer decision making, they would be eligible for participation afterwards
  • History of other malignancy besides current diagnosis of breast cancer, unless definitively treated more than 5 years ago
  • Any history of Hodgkin's disease requiring mantle field irradiation
  • Any previous diagnosis of breast cancer
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01881048
Other Study ID Numbers  ICMJE
NCI-2011-02967 ( Other Identifier: National Cancer Institute )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of Colorado, Denver
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Colorado, Denver
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Virginia Borges, MD, MSc University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP