Clinical trial · Interventional
Celecoxib Window of Opportunity Trial to Assess Tumor and Stroma Responses
NCT03185871CI-TRIAL-00041676withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Celecoxib | Drug | Celecoxib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Celecoxib
- description
- 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.
- interventionNames
- Drug: Celecoxib
Primary outcomes (1)
- measure
- Changes in collagen
- timeFrame
- Up to 6 weeks
- description
- To determine change of collagen structure and proliferation in response to celecoxib intake in the tumor microenvironment.
Secondary outcomes (11)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.