- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03185871
Celecoxib Window of Opportunity Trial to Assess Tumor and Stroma Responses
Study Overview
Detailed Description
Study Type
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants must have biopsy proven invasive breast carcinoma stages T1cN0 to T3N0, ER or PR positive with tumors greater than 1cm without lymph node spread.
- Participants must have a mammographic breast composition category (density) of c or d.
- Participants must be willing to participate and provide signed informed consent.
- Participants must have no immediate requirements for chemotherapy, radiotherapy or hormonal therapy.
- Participants must be willing to discontinue any use of NSAIDs like aspirin or ibuprofen until the tumor is removed
- Participants cannot be taking the following medications because of major pharmacokinetic interactions with celecoxib while being enrolled in the study: Abciximab, Argatroban, Bivalirudin, Cilostazol, Dabigatran, Etexilate, Dipyridamole, Fondaparinux, Heparin, Lepirudin, Pemetrexed, Protein C, Rivaroxaban, Sibutramine, Ticlopidine, Tirofiban, Vilazodone and Warfarin.
- Participants should pass MRI screening questionnaire
Exclusion Criteria:
- Prior history of cancer, neo-adjuvant chemotherapy and radiation therapy
- No daily NSAIDs intake within the past 4 weeks. Intermittent non-daily NSAIDs is allowed under PI discretion.
- Current or prior systemic use of corticosteroids in the past month.
- Participants with history of hypertension, congestive heart failure, edema, stroke or other cardiac disease or condition.
- Participants with type 2 diabetes, documented stomach ulcers and pulmonary embolism.
- Participants with aspirin or other NSAIDs-induced asthma or hypersensitivity reaction, sulfonamide allergy
- Participants who are currently pregnant
- Participants with known human immunodeficiency virus (HIV) infection, hepatitis B carrier state or with clinical evidence of hepatitis B.
- Participants who are not able to understand or provide written informed consent.
- Participants with standard contraindications to non-contrast MRI will be excluded, including claustrophobia and metallic implants incompatible with MRI.
- Participants whose girth exceeds the bore of the MRI scanner.
- Participants requiring conscious sedation for MR imaging.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Celecoxib
The participants will be scheduled for the two quantitative breast MRI exams. Following the first MRI exam, participants will start taking celecoxib 200mg twice a day with food. Subjects will take a minimum of 26 doses and no more than 32 doses of celecoxib during the study. Participants will intake 200mg of celecoxib two times a day (400mg/day total) for 2 weeks after biopsy. Histologic tissue samples will be obtained for evaluation at time of biopsy of the tumor and at time of surgery removal of the tumor. |
Celecoxib is the only COX-2 inhibitor currently approved by the FDA to be used in the United States.
Recently, it has been shown that celecoxib prevents sporadic colorectal adenomas and there are more clinical trials evaluating the use of celecoxib in combination with chemotherapy regimens in breast cancer settings.
Celebrex® oral capsules that will be used in this study contain 200 mg of celecoxib, in combination with inactive ingredients that include the following components: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in collagen
Time Frame: Up to 6 weeks
|
To determine change of collagen structure and proliferation in response to celecoxib intake in the tumor microenvironment.
|
Up to 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in correlation of collagen alignment and COX-2 expression
Time Frame: Up to 6 weeks
|
To evaluate correlation among collagen alignment and COX-2 expression before and after celecoxib intake.
|
Up to 6 weeks
|
Changes in Syndecan-1
Time Frame: Up to 6 weeks
|
To analyze Syndecan-1 expression levels as stromal response biomarkers.
|
Up to 6 weeks
|
Changes in CD68
Time Frame: Up to 6 weeks
|
To analyze CD68 expression levels as stromal response biomarkers.
|
Up to 6 weeks
|
Changes in CD163
Time Frame: Up to 6 weeks
|
To analyze CD163 expression levels as stromal response biomarkers.
|
Up to 6 weeks
|
Changes in neutrophil elastase
Time Frame: Up to 6 weeks
|
To analyze neutrophil elastase expression levels as stromal response biomarkers.
|
Up to 6 weeks
|
Changes in vimentin
Time Frame: Up to 6 weeks
|
To analyze vimentin expression levels as stromal response biomarkers.
|
Up to 6 weeks
|
Changes in α-SMA
Time Frame: Up to 6 weeks
|
To analyze α-SMA expression levels as stromal response biomarkers.
|
Up to 6 weeks
|
Changes in Ki67
Time Frame: Up to 6 weeks
|
To analyze Ki67 expression levels as stromal response biomarkers.
|
Up to 6 weeks
|
Changes in tissue cytokines in dense breast tissue
Time Frame: Up to 6 weeks
|
To discover tissue cytokines present in dense breast tissue that are altered in response to celecoxib.
|
Up to 6 weeks
|
Number of subjects with adverse events associated with celecoxib
Time Frame: Up to 6 weeks
|
To evaluate any adverse events associated with the 2-week intake of 200mg celecoxib twice a day.
|
Up to 6 weeks
|
Changes in collagen due to relationship of amount/percentage of fibroglandular tissue
Time Frame: Up to 6 weeks
|
To determine if changes in collagen structure and proliferation in response to celecoxib differ by the amount and/or percentage of fibroglandular tissue, measured quantitatively using MRI.
|
Up to 6 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mark Burkard, MD, University of Wisconsin, Madison
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Breast Diseases
- Breast Neoplasms
- Carcinoma
- 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
- UW16141
- P30CA014520 (U.S. NIH Grant/Contract)
- 2017-0219 (Other Identifier: Institutional Review Board)
- A534260 (Other Identifier: UW Madison)
- SMPH/MEDICINE/MEDICINE*H (Other Identifier: UW Madison)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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