InflammationPhase 2NCT01761877
NSAID Effects on Clinical and Imaging Breast Biomarkers
A Phase 2 study testing Sulindac in people with Inflammation and Cancer, run by Stony Brook University at 2 sites in United States.
Trial summary
This study has two purposes. One is to determine if daily sulindac decreases breast density; a risk factor for breast cancer development. The second is to determine whether sulindac reduces pain and stiffness associated with regular use of aromatase inhibitors given for the treatment of breast cancer. Read more about this study
- Who is it for?
- Ages Up to 75 years, women only
- Conditions the study is for
- Inflammation, Cancer, Pain
- What is being tested?
- Sulindac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2012to 11 Mar 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 75 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Eligibility criteria will include: Postmenopausal women with of first incidence of early stage (stages 0 - III) hormone receptor positive breast cancer stabilized on anastrozole therapy for at least 3 months
- Patients must have started on anastrozole and plan to continue on anastrozole therapy for a minimum of 12 months
- Patients must have an unaffected, non-irradiated contralateral breast with a baseline breast density score of > 25% as measured by standard digital mammography (BIRADs score > 2) or magnetic resonance imaging (MRI) performed within 12 months of randomization to the study
- A willingness to follow the study protocol, as indicated by provision of informed consent to participate
- A willingness to avoid taking NSAIDs outside of the trial (rare NSAID use for musculoskeletal symptoms excepted)
- Normal renal function as determined by a serum creatinine < upper limit of normal
- No known contraindication to NSAID use
- Normotensive or controlled blood pressure (< 140/90) on a single anti-hypertensive medication
Who cannot join
- Current or anticipated need for daily aspirin or NSAID use including aspirin for cardiovascular protection
- Known intolerance to NSAIDs
- Age > 75 years
- History of cardiovascular disease including prior myocardial infarction, angina, stroke, or transient ischemic attack (TIA)
- Diabetes requiring drug therapy
- Current smoker
Show all 13Show fewer
- History of Uncontrolled hypertension
- Blood pressure > 140/90 at baseline by home monitoring
- History of GI ulcers, chronic GERD, or GI bleeding in the past 5 years
- History of a bleeding diathesis or current anticoagulant therapy
- Daily therapy with H2 blockers or protein pump inhibitors
- History of claustrophobia
- Have electrically, magnetically, or mechanically activated implants including cardiac pacemaker, cochlear implants, magnetic surgical clips or prostheses.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Stony Brook University Cancer Center
Stony Brook, New York, 11794
University of Arizona Cancer Center
Tucson, Arizona, 85724
About this study
This study has two purposes. One is to determine if daily sulindac decreases breast density; a risk factor for breast cancer development. The second is to determine whether sulindac reduces pain and stiffness associated with regular use of aromatase inhibitors given for the treatment of breast cancer.
Read the detailed description
To accomplish our study aims, we will conduct a phase II, single are trial of sulindac in postmenopausal women with early stage ER+ breast cancer who are receiving an aromatase inhibitor as adjuvant hormonal therapy. Approximately 75 breast cancer patients, stable on AI therapy (minimum of 3 months) for the treatment of their breast cancer will receive sulindac 150 mg bid for 12 months. Breast imaging will be conducted at baseline, 6 and 12 months.
The primary endpoint of the study will be change in the appearance of the contralateral, uninvolved breast as measured by quantitative Fat Water Ratio (FWR-MRI) mapping at 12 months in response to sulindac therapy. As changes in breast density in the contralateral, uninvolved breast will be the primary endpoint of the study, patients with bilateral breast cancer or those patients undergoing bilateral mastectomies or reconstruction surgery will be ineligible. Secondary endpoints of the trial include 12 month change in general pain and joint specific stiffness and pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). A number of exploratory endpoints are planned and include comparison of MRI measures of the breast, tissue biomarkers, and pain at 6 months as early indicators of 12 month responses. For the tissue biomarkers, core needle biopsies will be obtained in a subset of women who consent to the procedure from the uninvolved contralateral breast at baseline and at 6 months. Tissue studies will include characterization of tissue histology (graded by cellularity and stromal elements) and molecular measures of proliferation and apoptosis.
- Conditions
- Inflammation, Cancer, Pain, Hypertension
- Being tested
- Sulindac
- Keywords
- breast cancer, breast density, chemoprevention
- Medical subject headings
- Inflammation, Neoplasms, Pain, Hypertension, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulindacDrug
Also called Clinoril
| Study group | Role | What they receive |
|---|---|---|
| Sulindac (Clinoril) | Experimental | Women taking aromatase inhibitors for adjuvant therapy for their breast cancer will receive 150 mg of sulindac twice daily for 12 months. They will receive up to 4 MRI within 12 months. Receives: Drug: Sulindac |
| Observational | No intervention | Women taking aromatase inhibitors for adjuvant therapy for their breast cancer will continue their treatment will be monitored with MRI and standard of care tests every 6 months for up to 12 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Breast Density Measured as Fat to Water Ratio by Magnetic Resonance Imaging
Adjusted estimates of relative change in percent breast density by magnetic resonance imaging
Measured: Baseline and 12 months
Secondary outcomes (1)
Muscle and Joint Pain and Stiffness
The endpoint for arthralgia is change from baseline in Total Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index scores on a scale at 12 months. The Western Ontario and McMaster Universities Index is a self-administered questionnaire consisting of 24 items divided in 3 subscales: Pain, Stiffness, and Physical Function. Scores on the scale range from 0 to 96 for total WOMAC where 0 represents the best health status and 96 the worst possible status.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startDec 2012
- Primary completion7 Feb 2019
- Study completion11 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alison Stopeck, Stony Brook University
- Investigators
- Patricia Thompson-Carino, PhD, Principal investigator, Stony Brook UniversityAlison Stopeck, MD, Principal investigator, Stony Brook UniversityPavani Chalasani, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761877
- Sponsor's protocol ID
- 1RO1 CA1615301A1
- Other IDs
- 12-0080-04, 676847
- Status last verified
- Jan 2023
- First submitted
- 28 Dec 2012
- Last updated
- 10 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Martinez JA, Wertheim BC, Roe DJ, Chalasani P, Cohen J, Baer L, Chow HS, Stopeck AT, Thompson PA. Sulindac Improves Stiffness and Quality of Life in Women Taking Aromatase Inhibitors for Breast Cancer. Breast Cancer Res Treat. 2022 Feb;192(1):113-122. doi: 10.1007/s10549-021-06485-0. Epub 2022 Jan 18.
PubMed 35039952
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NSAID Effects on Clinical and Imaging Breast Biomarkers
- ClinicalTrials.gov ID
- NCT01761877
- Acronym / sponsor ID
- 1RO1 CA1615301A1
- Conditions
- Inflammation, Cancer, Pain, Hypertension
- Keywords
- breast cancer, breast density, chemoprevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- 7 Feb 2019 (actual)
- Study completion
- 11 Mar 2019 (actual)
- First posted
- 7 Jan 2013 (estimated)
- Results
- Posted 10 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study has two purposes. One is to determine if daily sulindac decreases breast density; a risk factor for breast cancer development. The second is to determine whether sulindac reduces pain and stiffness associated with regular use of aromatase inhibitors given for the treatment of breast cancer.
Detailed description
To accomplish our study aims, we will conduct a phase II, single are trial of sulindac in postmenopausal women with early stage ER+ breast cancer who are receiving an aromatase inhibitor as adjuvant hormonal therapy. Approximately 75 breast cancer patients, stable on AI therapy (minimum of 3 months) for the treatment of their breast cancer will receive sulindac 150 mg bid for 12 months. Breast imaging will be conducted at baseline, 6 and 12 months.
The primary endpoint of the study will be change in the appearance of the contralateral, uninvolved breast as measured by quantitative Fat Water Ratio (FWR-MRI) mapping at 12 months in response to sulindac therapy. As changes in breast density in the contralateral, uninvolved breast will be the primary endpoint of the study, patients with bilateral breast cancer or those patients undergoing bilateral mastectomies or reconstruction surgery will be ineligible. Secondary endpoints of the trial include 12 month change in general pain and joint specific stiffness and pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). A number of exploratory endpoints are planned and include comparison of MRI measures of the breast, tissue biomarkers, and pain at 6 months as early indicators of 12 month responses. For the tissue biomarkers, core needle biopsies will be obtained in a subset of women who consent to the procedure from the uninvolved contralateral breast at baseline and at 6 months. Tissue studies will include characterization of tissue histology (graded by cellularity and stromal elements) and molecular measures of proliferation and apoptosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sulindac (Clinoril) | Experimental | Drug: SulindacWomen taking aromatase inhibitors for adjuvant therapy for their breast cancer will receive 150 mg of sulindac twice daily for 12 months. They will receive up to 4 MRI within 12 months. |
| Observational | No intervention | –Women taking aromatase inhibitors for adjuvant therapy for their breast cancer will continue their treatment will be monitored with MRI and standard of care tests every 6 months for up to 12 months. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Eligibility criteria will include: Postmenopausal women with of first incidence of early stage (stages 0 - III) hormone receptor positive breast cancer stabilized on anastrozole therapy for at least 3 months
- Patients must have started on anastrozole and plan to continue on anastrozole therapy for a minimum of 12 months
- Patients must have an unaffected, non-irradiated contralateral breast with a baseline breast density score of > 25% as measured by standard digital mammography (BIRADs score > 2) or magnetic resonance imaging (MRI) performed within 12 months of randomization to the study
- A willingness to follow the study protocol, as indicated by provision of informed consent to participate
- A willingness to avoid taking NSAIDs outside of the trial (rare NSAID use for musculoskeletal symptoms excepted)
Key exclusion criteria (13 listed)
- Current or anticipated need for daily aspirin or NSAID use including aspirin for cardiovascular protection
- Known intolerance to NSAIDs
- Age > 75 years
- History of cardiovascular disease including prior myocardial infarction, angina, stroke, or transient ischemic attack (TIA)
- Diabetes requiring drug therapy
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 |
|---|---|---|
| SulindacAlso: Clinoril | Drug | Sulindac (Clinoril) |
Primary outcome
Change in Breast Density Measured as Fat to Water Ratio by Magnetic Resonance Imaging
Time frame: Baseline and 12 months
Adjusted estimates of relative change in percent breast density by magnetic resonance imaging
1 secondary outcome
Muscle and Joint Pain and Stiffness
Time frame: Baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35039952Martinez JA, Wertheim BC, Roe DJ, Chalasani P, Cohen J, Baer L, Chow HS, Stopeck AT, Thompson PA. Sulindac Improves Stiffness and Quality of Life in Women Taking Aromatase Inhibitors for Breast Cancer. Breast Cancer Res Treat. 2022 Feb;192(1):113-122. doi: 10.1007/s10549-021-06485-0. Epub 2022 Jan 18.
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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.
Patricia Thompson-Carino, PhD principal investigator
Stony Brook University
Alison Stopeck, MD principal investigator
Stony Brook University
Pavani Chalasani, MD principal investigator
University of Arizona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sulindac in people with Inflammation and Cancer, run by Stony Brook University at 2 sites in United States.
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 8 inclusion and 13 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: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 10 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Breast Density Measured as Fat to Water Ratio by Magnetic Resonance Imaging (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01761877, which also lists 1 linked publication.
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 10 Feb 2023.