- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01881048
Window of Opportunity Study Targeting the Inflammatory Milieu
February 2, 2024 updated by: University of Colorado, Denver
Window of Opportunity Study Targeting the Inflammatory Milieu of Pregnancy Associated Breast Cancer
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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
Enrollment (Actual)
42
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Arm I
Patients undergo observation.
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Experimental: Arm II (fish oil)
Patients receive omega-3 fatty acid by mouth everyday until the morning of surgery.
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Given PO
Other Names:
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Experimental: Arm III (celecoxib)
Patients receive celecoxib by mouth twice a day until the morning of surgery.
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Given PO
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Baseline and 1 week
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Virginia Borges, MD, MSc, University of Colorado, Denver
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 8, 2009
Primary Completion (Actual)
January 14, 2014
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
June 14, 2013
First Submitted That Met QC Criteria
June 18, 2013
First Posted (Estimated)
June 19, 2013
Study Record Updates
Last Update Posted (Estimated)
February 5, 2024
Last Update Submitted That Met QC Criteria
February 2, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Celecoxib
Other Study ID Numbers
- 08-0104.cc
- NCI-2011-02967 (Other Identifier: National Cancer Institute)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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