Stage IA Breast CancerEarly Phase 1NCT01881048
Window of Opportunity Study Targeting the Inflammatory Milieu
A Early Phase 1 study testing Omega-3 fatty acid and Celecoxib in people with Stage IA Breast Cancer and Stage IB Breast Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of two anti-inflammatory drugs, fish oil capsules and the COX-2 inhibitor celecoxib, on pregnancy associated breast cancer (PABC). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer
- What is being tested?
- Omega-3 fatty acid and Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2009to 14 Dec 2015
- Phase
- Early Phase 1
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age greater or equal to 18 and less than or equal to 50.
- Histological or cytological confirmation of breast cancer; for patients with fine needle aspiration (FNA), a core biopsy must be intended
- For patients diagnosed with needle core or excisional biopsy, formalin-fixed paraffin embedded tumor blocks or unstained slides must be available or patient must be willing to undergo repeat core biopsy for research purposes as part of study procedures (biopsy for fresh/ fresh frozen tissue is otherwise optional)
- Any clinical stage allowed provided definitive local resection intended and neoadjuvant treatment not intended
- Patient must be planned to proceed to definitive surgery for their breast cancer at least 1 week or more after diagnosis
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Show all 13Show fewer
- Patient must have laboratory parameters as follows:
- Liver function tests (Total bilirubin, aspartate aminotransferase, alanine aminotrasferase, alkaline phasphataseAST) =< 2 x ULN
- Platelet count greater than or equal to institutional lower limit of normal (LLN)
- Patient cannot have greater than grade 1 anemia as determined by hematocrit (Hct)
- Written informed consent obtained prior to any initiation of study procedures
- Willingness to abstain from either fish oil or celebrex for study period if randomized to control arm
- Women who are lactating at time of diagnosis are eligible provided they complete weaning prior to starting study drug
Who cannot join
- Known autoimmune condition, chronic steroid use, underlying immune disease (other than breast cancer), use of immunomodulatory prescription drugs for any medical condition
- Known allergy or intolerance to fish oil, fish, non-steroidal anti-inflammatory drugs (NSAIDS), acetylsalicylic acid (ASA) or cyclooxygenase-2 (COX 2) inhibitors
- Known bleeding diathesis or history of peptic ulcer disease; gastroesophageal reflux allowed if controlled
- Currently taking greater than one 1000mg fish oil capsule daily or celecoxib at baseline, unless willing to stop consumption 1 week prior to starting study
- History of stroke, transient ischemic attack (TIA) or coronary artery disease
- The presence of other comorbid conditions known to impact immune function, (such as: type I diabetes, uncontrolled adult onset diabetes, severe chronic obstructive pulmonary disease (COPD), uncontrolled infection or known human immunodeficiency virus [HIV] infection)
Show all 11Show fewer
- Underlying psychiatric condition which would, in the opinion of the investigator, preclude compliance with study requirements
- Women who are pregnant at time of breast cancer diagnosis and intend to continue the pregnancy; if pregnancy is terminated per patient's cancer decision making, they would be eligible for participation afterwards
- History of other malignancy besides current diagnosis of breast cancer, unless definitively treated more than 5 years ago
- Any history of Hodgkin's disease requiring mantle field irradiation
- Any previous diagnosis of breast cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Cancer Center
Aurora, Colorado, 80045
About this study
Official title: Window of Opportunity Study Targeting the Inflammatory Milieu of Pregnancy Associated Breast Cancer
The purpose of this study is to evaluate the effect of two anti-inflammatory drugs, fish oil capsules and the COX-2 inhibitor celecoxib, on pregnancy associated breast cancer (PABC). Short-term intervention with anti-inflammatory medications will demonstrate a reduction in the inflammation and immune suppressive phenotype of PABC, and decreased metastatic potential in PABC. This unique window in breast cancer management serves as a valuable opportunity to obtain preliminary data on biomarkers and the alterations that occur when the system is troubled by a drug or other intervention which will be instrumental in designing future therapeutic or preventative strategies for larger clinical study.
Read the detailed description
This randomized pilot clinical trial studies omega-3 fatty acid or celecoxib in treating patients with breast cancer planning to undergo surgery. Omega-3 fatty acid may stimulate the immune system in different ways and stop tumor cells from growing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether omega-3 fatty acid or celecoxib is more effective in treating breast cancer.
- Conditions
- Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
- Being tested
- Omega-3 fatty acid, Celecoxib
- Keywords
- Breast cancer, Omega-3 Fatty Acid, Celecoxib, Celebrex, Surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fatty acidDietary supplement
Also called fish oil, n-3 fatty acid, omega-3 polyunsaturated fatty acid
Given PO
CelecoxibDrug
Also called Celebrex
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm I | No intervention | Patients undergo observation. |
| Arm II (fish oil) | Experimental | Patients receive omega-3 fatty acid by mouth everyday until the morning of surgery. Receives: Dietary Supplement: Omega-3 fatty acid |
| Arm III (celecoxib) | Experimental | Patients receive celecoxib by mouth twice a day until the morning of surgery. Receives: Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean Ki-67 index in patients receiving either omega-3 fatty acid or celecoxib for 1 or more weeks as compared to controls
Tumor cells are stained using the Ki-67 monoclonal antibody. Ki-67 is measured as a percentage of positive tumor cells. The investigator will conduct three paired t-tests comparing the percent Ki-67 at baseline to the percent Ki-67 after treatment. There will be one t-test for each arm.
Measured: Baseline and 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study start8 Dec 2009
- Primary completion14 Jan 2014
- Study completion14 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IA Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virginia Borges, MD, MSc, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881048
- Sponsor's protocol ID
- 08-0104.cc
- Other IDs
- NCI-2011-02967
- Status last verified
- Jan 2026
- First submitted
- 14 Jun 2013
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Window of Opportunity Study Targeting the Inflammatory Milieu of Pregnancy Associated Breast Cancer
- ClinicalTrials.gov ID
- NCT01881048
- Acronym / sponsor ID
- 08-0104.cc
- Conditions
- Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
- Keywords
- Breast cancer, Omega-3 Fatty Acid, Celecoxib, Celebrex, Surgery
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 8 Dec 2009 (actual)
- Primary completion
- 14 Jan 2014 (actual)
- Study completion
- 14 Dec 2015 (actual)
- First posted
- 19 Jun 2013 (estimated)
- 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 purpose of this study is to evaluate the effect of two anti-inflammatory drugs, fish oil capsules and the COX-2 inhibitor celecoxib, on pregnancy associated breast cancer (PABC). Short-term intervention with anti-inflammatory medications will demonstrate a reduction in the inflammation and immune suppressive phenotype of PABC, and decreased metastatic potential in PABC. This unique window in breast cancer management serves as a valuable opportunity to obtain preliminary data on biomarkers and the alterations that occur when the system is troubled by a drug or other intervention which will be instrumental in designing future therapeutic or preventative strategies for larger clinical study.
Detailed description
This randomized pilot clinical trial studies omega-3 fatty acid or celecoxib in treating patients with breast cancer planning to undergo surgery. Omega-3 fatty acid may stimulate the immune system in different ways and stop tumor cells from growing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether omega-3 fatty acid or celecoxib is more effective in treating breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I | No intervention | –Patients undergo observation. |
| Arm II (fish oil) | Experimental | Dietary Supplement: Omega-3 fatty acidPatients receive omega-3 fatty acid by mouth everyday until the morning of surgery. |
| Arm III (celecoxib) | Experimental | Drug: CelecoxibPatients receive celecoxib by mouth twice a day until the morning of surgery. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Age greater or equal to 18 and less than or equal to 50.
- Histological or cytological confirmation of breast cancer; for patients with fine needle aspiration (FNA), a core biopsy must be intended
- For patients diagnosed with needle core or excisional biopsy, formalin-fixed paraffin embedded tumor blocks or unstained slides must be available or patient must be willing to undergo repeat core biopsy for research purposes as part of study procedures (biopsy for fresh/ fresh frozen tissue is otherwise optional)
- Any clinical stage allowed provided definitive local resection intended and neoadjuvant treatment not intended
- Patient must be planned to proceed to definitive surgery for their breast cancer at least 1 week or more after diagnosis
Key exclusion criteria (11 listed)
- Known autoimmune condition, chronic steroid use, underlying immune disease (other than breast cancer), use of immunomodulatory prescription drugs for any medical condition
- Known allergy or intolerance to fish oil, fish, non-steroidal anti-inflammatory drugs (NSAIDS), acetylsalicylic acid (ASA) or cyclooxygenase-2 (COX 2) inhibitors
- Known bleeding diathesis or history of peptic ulcer disease; gastroesophageal reflux allowed if controlled
- Currently taking greater than one 1000mg fish oil capsule daily or celecoxib at baseline, unless willing to stop consumption 1 week prior to starting study
- History of stroke, transient ischemic attack (TIA) or coronary artery disease
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 |
|---|---|---|
| Omega-3 fatty acidAlso: fish oil, n-3 fatty acid, omega-3 polyunsaturated fatty acidGiven PO | Dietary supplement | Arm II (fish oil) |
| CelecoxibAlso: CelebrexGiven PO | Drug | Arm III (celecoxib) |
Primary outcome
Change in mean Ki-67 index in patients receiving either omega-3 fatty acid or celecoxib for 1 or more weeks as compared to controls
Time frame: Baseline and 1 week
Tumor cells are stained using the Ki-67 monoclonal antibody. Ki-67 is measured as a percentage of positive tumor cells. The investigator will conduct three paired t-tests comparing the percent Ki-67 at baseline to the percent Ki-67 after treatment. There will be one t-test for each arm.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Stage IA Breast Cancer
Active, not recruiting
Improving Patient-Centered Communication in Breast Cancer Through Patient and Provider Interventions
Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8
Active, not recruitingPhase 3
S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer
Breast Cancer
Active, not recruitingPhase 2
Electroacupuncture Therapy in Reducing Chronic Pain in Patients After Breast Cancer Treatment
Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7
Recruiting
Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
Active, not recruiting
Identifying Decision Making Needs for Older Adult Women With Stage I-III Breast Cancer Considering Neoadjuvant or Adjuvant Chemotherapy
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
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.
Virginia Borges, MD, MSc principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Omega-3 fatty acid and Celecoxib in people with Stage IA Breast Cancer and Stage IB Breast Cancer, run by University of Colorado, Denver at 1 site 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 13 inclusion and 11 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 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 mean Ki-67 index in patients receiving either omega-3 fatty acid or celecoxib for 1 or more weeks as compared to controls (time frame: Baseline and 1 week). 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 29 Jan 2026.