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Window of Opportunity Study Targeting the Inflammatory Milieu

Primary Purpose

Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer

Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Omega-3 fatty acid
Celecoxib
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IA Breast Cancer focused on measuring Breast cancer, Omega-3 Fatty Acid, Celecoxib, Celebrex, Surgery

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • University of Colorado Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Arm I

Arm II (fish oil)

Arm III (celecoxib)

Arm Description

Patients undergo observation.

Patients receive omega-3 fatty acid by mouth everyday until the morning of surgery.

Patients receive celecoxib by mouth twice a day until the morning of surgery.

Outcomes

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
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.

Secondary Outcome Measures

Full Information

First Posted
June 14, 2013
Last Updated
January 30, 2023
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT01881048
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 8, 2009 (Actual)
Primary Completion Date
January 14, 2014 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Breast cancer, Omega-3 Fatty Acid, Celecoxib, Celebrex, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
No Intervention
Arm Description
Patients undergo observation.
Arm Title
Arm II (fish oil)
Arm Type
Experimental
Arm Description
Patients receive omega-3 fatty acid by mouth everyday until the morning of surgery.
Arm Title
Arm III (celecoxib)
Arm Type
Experimental
Arm Description
Patients receive celecoxib by mouth twice a day until the morning of surgery.
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 fatty acid
Other Intervention Name(s)
fish oil, n-3 fatty acid, omega-3 polyunsaturated fatty acid
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Other Intervention Name(s)
Celebrex
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
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
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.
Time Frame
Baseline and 1 week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginia Borges, MD, MSc
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Window of Opportunity Study Targeting the Inflammatory Milieu

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