Celecoxib Window of Opportunity Trial to Assess Tumor and Stroma Responses

NCT03185871 | Withdrawn Phase 2 FDA Drug

• 5 other identifiers: UW16141P30CA0145202017-0219A534260SMPH/MEDICINE/MEDICINE*H
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The overall purpose of this study is to assess whether celecoxib can reduce the change in collagen alignment and inflammatory response in the tumor tissue of primary breast cancer patients with invasive breast carcinoma after 2 weeks of oral intake.

Conditions

Breast Carcinoma

Keywords

Invasive breast carcinoma; breast carcinoma stage T1cN0 to N3N0

Outcome Measures

Primary Outcomes (1)

• Changes in collagen

  To determine change of collagen structure and proliferation in response to celecoxib intake in the tumor microenvironment.

  Up to 6 weeks

Secondary Outcomes (11)

• Change in correlation of collagen alignment and COX-2 expression

  Up to 6 weeks

• Changes in Syndecan-1

  Up to 6 weeks

• Changes in CD68

  Up to 6 weeks

• Changes in CD163

  Up to 6 weeks

• Changes in neutrophil elastase

  Up to 6 weeks

Study Arms (1)

Celecoxib

EXPERIMENTAL

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.

Drug: Celecoxib

Interventions

Celecoxib DRUG

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.

Also known as: Celebrex

Celecoxib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Cancer Institute (NCI): collaborator

Related Links

• University of Wisconsin Carbone Cancer Center Homepage

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mark Burkard, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Due to the characteristics of the design of this clinical trial, the patient will not be blinded but the researcher completing analysis will be. The researcher will be handling deidentified patient samples and comparing whether there are changes of biological markers within the same patient before and after celecoxib intake. It is important that the researcher be as unbiased as possible when analyzing collagen alignment and amount of other breast cancer biological markers.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 14, 2017
• Study Start: September 20, 2017
• Primary Completion: October 10, 2018
• Study Completion: October 10, 2018
• Last Updated: November 15, 2019

Record last verified: 2018-10