Celecoxib Window of Opportunity Trial to Assess Tumor and Stroma Responses

• Status: Withdrawn
• Trial end date: 2018-10-10
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborator: National Cancer Institute (NCI)
• Treatments: Celecoxib

Criteria

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.