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Protocol No. UW16141

Principal Investigator Burkard, Mark

Phase II

Age Group Adult

Scope Local

Sponsor Type Institutional

Title Celecoxib Window of Opportunity Trial to Assess Tumor and Stroma Responses

Objective The purpose of the research is to see what effects celecoxib prior to surgery will have on invasive breast cancer. The study provides a way to look at changes in the breast tissue before and after taking celecoxib. Changes in the breast tissue before and after taking celecoxib may help physicians determine what treatments for breast cancer are more likely to be effective for individual patients.

Treatment The drug used in this study is celecoxib, a non-steroidal anti-inflammatory drug similar to ibuprofen. Celecoxib works by reducing hormones in the body that cause inflammation, pain, and fever. It has been shown in mice with dense mammary glands that celecoxib significantly delays tumor formation and decreases breast density. It has also been demonstrated in other forms of cancer that celecoxib alone or in combination with chemotherapy regimens is effective. However, we still need to identify celecoxib's effect in relation to breast cancer patients with dense breasts.

Description The study will require you to come to clinic 5 times during participation. The first will be a screening visit. If eligible and you decide to participate, there will be 3 visits while taking celecoxib, and once for an End of Study visit. An MRI to look at your breast density will be done before the first dose of celecoxib. After completeing celecoxib, a second breast MRI exam will look for any changes in your breast density caused by the celecoxib drug. Celecoxib is an oral tablet that you will take twice a day for 2 weeks. You will be on study for about 6 weeks. More information can be found at

Key Eligibility
  • 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 will be females, 18 to 80 years of age
  • Participants must have a mammographic breast composition category (density) of c or d
  • 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
  • Patient should pass MRI screening questionnaire
  • Patients with prior history of cancer, neo-adjuvant chemotherapy and radiation therapy are excluded
  • No daily NSAIDs intake within the past 4 weeks are allowed
  • Patients with current or prior systemic use of corticosteroids in the past month are ineligible
  • Patients with history of hypertension, congestive heart failure, edema, stroke or other cardiac disease or condition are excluded
  • Participants with type 2 diabetes, documented stomach ulcers and pulmonary embolism are excluded
  • Participants with aspirin or other NSAIDs-induced asthma or hypersensitivity reaction, sulfonamide allergy are excluded
  • Participants who are currently pregnant are excluded
  • Participants with known human immunodeficiency virus (HIV) infection, hepatitis B carrier state or with clinical evidence of hepatitis B are excluded
  • Participants requiring conscious sedation for MR imaging are excluded

Applicable Disease Sites Breast

Therapies Involved Other

Drugs Involved Celecoxib

Status Open

Participating Institutions UW Hospital and Clinics