Window of Opportunity Study Targeting the Inflammatory Milieu

• ClinicalTrials.gov Identifier: NCT01881048
• Recruitment Status: Active, not recruiting
• First Posted: June 19, 2013
• Last Update Posted: January 31, 2023
• Sponsor: University of Colorado, Denver
• Information provided by (Responsible Party): University of Colorado, Denver

Tracking Information

• First Submitted Date: June 14, 2013
• First Posted Date: June 19, 2013
• Last Update Posted Date: January 31, 2023
• Actual Study Start Date: December 8, 2009
• Actual Primary Completion Date: January 14, 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Window of Opportunity Study Targeting the Inflammatory Milieu
• Official Title: 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: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• 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

• 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

• 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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: October 5, 2016): 42
• Original Estimated Enrollment (submitted: June 18, 2013): 50
• Estimated Study Completion Date: December 2023
• Actual Primary Completion Date: January 14, 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Female

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01881048
• Other Study ID Numbers: 08-0104.cc; NCI-2011-02967 ( Other Identifier: National Cancer Institute )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University of Colorado, Denver
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Colorado, Denver
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Virginia Borges, MD, MSc; University of Colorado, Denver

• PRS Account: University of Colorado, Denver
• Verification Date: January 2023