Window of Opportunity Study Targeting the Inflammatory Milieu

Sponsor

University of Colorado, Denver (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01881048

Collaborator

(none)

Enrollment

Location

Arms

155.8

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	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

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 Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 8, 2009

Actual Primary Completion Date :

Jan 14, 2014

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Celebrex

Arm

Intervention/Treatment

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 Names:

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 Names:

Celebrex

Outcome Measures

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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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