Breast CarcinomaPhase 2NCT03185871
Celecoxib Window of Opportunity Trial to Assess Tumor and Stroma Responses
A Phase 2 study testing Celecoxib in people with Breast Carcinoma, run by University of Wisconsin, Madison.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2017to 10 Oct 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
About this study
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.
Read the detailed description
Advances in early detection techniques and improvement in systemic treatment of early stage breast cancer have led to a small decline in overall breast cancer mortality in the last 20 years. New advances will require understanding of breast cancer biology at the molecular level. Inhibition of COX-2 and its analysis of effect in breast cancer tumor microenvironment provide one such fruitful therapeutic target. Tumor microenvironment is poorly understood in breast cancer research. Despite new drugs being developed to treat breast cancer and tested in clinical trials, it is rarely possible to assess how the drug is affecting the breast cancer cells at a molecular level. The use of collagen properties such as alignment and deposition will allow giving a faster diagnosis of breast cancer status and seeing how celecoxib with respect to collagen can change the tumor microenvironment in human tissue. This window trial provides a way to look at cancer and stromal cells before and after celecoxib intake to see if the drug is actively working. If we can do this before and after a patient has surgery, and see how the tumor microenvironment responds, then the physician could pick a better suited adjuvant treatment for this patient after surgical intervention that would improve their overall survival rate.
- Conditions
- Breast Carcinoma
- Being tested
- Celecoxib
- Keywords
- Invasive breast carcinoma, breast carcinoma stage T1cN0 to N3N0
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Also called Celebrex
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in collagen
To determine change of collagen structure and proliferation in response to celecoxib intake in the tumor microenvironment.
Measured: Up to 6 weeks
Secondary outcomes (11)
Change in correlation of collagen alignment and COX-2 expression
To evaluate correlation among collagen alignment and COX-2 expression before and after celecoxib intake.
Measured: Up to 6 weeks
Changes in Syndecan-1
To analyze Syndecan-1 expression levels as stromal response biomarkers.
Measured: Up to 6 weeks
Changes in CD68
To analyze CD68 expression levels as stromal response biomarkers.
Measured: Up to 6 weeks
Changes in CD163
To analyze CD163 expression levels as stromal response biomarkers.
Measured: Up to 6 weeks
Changes in neutrophil elastase
To analyze neutrophil elastase expression levels as stromal response biomarkers.
Measured: Up to 6 weeks
Changes in vimentin
To analyze vimentin expression levels as stromal response biomarkers.
Measured: Up to 6 weeks
Changes in α-SMA
To analyze α-SMA expression levels as stromal response biomarkers.
Measured: Up to 6 weeks
Changes in Ki67
To analyze Ki67 expression levels as stromal response biomarkers.
Measured: Up to 6 weeks
Changes in tissue cytokines in dense breast tissue
To discover tissue cytokines present in dense breast tissue that are altered in response to celecoxib.
Measured: Up to 6 weeks
Number of subjects with adverse events associated with celecoxib
To evaluate any adverse events associated with the 2-week intake of 200mg celecoxib twice a day.
Measured: Up to 6 weeks
Changes in collagen due to relationship of amount/percentage of fibroglandular tissue
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.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start20 Sep 2017
- Primary completion10 Oct 2018
- Study completion10 Oct 2018
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mark Burkard, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185871
- Sponsor's protocol ID
- UW16141
- Other IDs
- P30CA014520, 2017-0219, A534260, SMPH/MEDICINE/MEDICINE*H
- Status last verified
- Oct 2018
- First submitted
- 9 Jun 2017
- Last updated
- 15 Nov 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Celecoxib Window of Opportunity Trial to Assess Tumor and Stroma Responses
- ClinicalTrials.gov ID
- NCT03185871
- Acronym / sponsor ID
- UW16141
- Conditions
- Breast Carcinoma
- Keywords
- Invasive breast carcinoma, breast carcinoma stage T1cN0 to N3N0
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Slow accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Advances in early detection techniques and improvement in systemic treatment of early stage breast cancer have led to a small decline in overall breast cancer mortality in the last 20 years. New advances will require understanding of breast cancer biology at the molecular level. Inhibition of COX-2 and its analysis of effect in breast cancer tumor microenvironment provide one such fruitful therapeutic target. Tumor microenvironment is poorly understood in breast cancer research. Despite new drugs being developed to treat breast cancer and tested in clinical trials, it is rarely possible to assess how the drug is affecting the breast cancer cells at a molecular level. The use of collagen properties such as alignment and deposition will allow giving a faster diagnosis of breast cancer status and seeing how celecoxib with respect to collagen can change the tumor microenvironment in human tissue. This window trial provides a way to look at cancer and stromal cells before and after celecoxib intake to see if the drug is actively working. If we can do this before and after a patient has surgery, and see how the tumor microenvironment responds, then the physician could pick a better suited adjuvant treatment for this patient after surgical intervention that would improve their overall survival rate.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Celecoxib | Experimental | Drug: CelecoxibThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CelecoxibAlso: CelebrexCelecoxib 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. | Drug | Celecoxib |
Primary outcome
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.
11 secondary outcomes
Change in correlation of collagen alignment and COX-2 expression
Time frame: Up to 6 weeks
Changes in Syndecan-1
Time frame: Up to 6 weeks
Changes in CD68
Time frame: Up to 6 weeks
Changes in CD163
Time frame: Up to 6 weeks
Changes in neutrophil elastase
Time frame: Up to 6 weeks
Changes in vimentin
Time frame: Up to 6 weeks
Changes in α-SMA
Time frame: Up to 6 weeks
Changes in Ki67
Time frame: Up to 6 weeks
Changes in tissue cytokines in dense breast tissue
Time frame: Up to 6 weeks
Number of subjects with adverse events associated with celecoxib
Time frame: Up to 6 weeks
Changes in collagen due to relationship of amount/percentage of fibroglandular tissue
Time frame: Up to 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- University of Wisconsin Carbone Cancer Center HomepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Burkard, MD principal investigator
University of Wisconsin, Madison
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Celecoxib in people with Breast Carcinoma, run by University of Wisconsin, Madison.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in collagen (time frame: Up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2019.