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Trial record 1 of 1 for:    NCT01881048
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Window of Opportunity Study Targeting the Inflammatory Milieu

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01881048
First received: June 14, 2013
Last updated: October 5, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention Phase
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
Dietary Supplement: Omega-3 fatty acid
Drug: Celecoxib
Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Window of Opportunity Study Targeting the Inflammatory Milieu of Pregnancy Associated Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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.


Enrollment: 42
Study Start Date: August 2009
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Dietary Supplement: Omega-3 fatty acid
Given PO
Other Name: fish oil, n-3 fatty acid, omega-3 polyunsaturated fatty acid
Experimental: Arm III (celecoxib)
Patients receive celecoxib by mouth twice a day until the morning of surgery.
Drug: Celecoxib
Given PO
Other Name: Celebrex

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.
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01881048

Locations
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Virginia Borges, MD, MSc University of Colorado, Denver
  More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01881048     History of Changes
Other Study ID Numbers: 08-0104.cc
NCI-2011-02967 ( Other Identifier: National Cancer Institute )
Study First Received: June 14, 2013
Last Updated: October 5, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Colorado, Denver:
Breast cancer
Omega-3 Fatty Acid
Celecoxib
Celebrex
Surgery

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on March 29, 2017