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Window of Opportunity Study Targeting the Inflammatory Milieu of Pregnancy Associated Breast Cancer

Phase 0
18 Years
50 Years
Open (Enrolling)
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

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Trial Information

Window of Opportunity Study Targeting the Inflammatory Milieu of Pregnancy Associated Breast Cancer

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

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

Baseline and 1 week

Safety Issue:


Principal Investigator

Virginia Borges, MD, MSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado, Denver


United States: Institutional Review Board

Study ID:



Start Date:

August 2009

Completion Date:

August 2014

Related Keywords:

  • 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
  • Breast cancer
  • Omega-3 Fatty Acid
  • Celecoxib
  • Celebrex
  • Surgery
  • Breast Neoplasms



University of Colorado Cancer Center Denver, Colorado  80262