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 : November 15, 2018
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Window of Opportunity Study Targeting the Inflammatory Milieu of Pregnancy Associated Breast Cancer|
|Actual Study Start Date :||December 8, 2009|
|Actual Primary Completion Date :||January 14, 2014|
|Estimated Study Completion Date :||October 2019|
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
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.
Other Name: Celebrex
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881048
|United States, Colorado|
|University of Colorado Cancer Center|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Virginia Borges, MD, MSc||University of Colorado, Denver|