Stage I Breast CancerPhase 1NCT00070057
Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer
A Phase 1 study testing celecoxib, therapeutic conventional surgery and pharmacological study in people with Stage I Breast Cancer and Stage II Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This randomized phase I trial is studying the side effects of celecoxib in treating postmenopausal women with invasive breast cancer who are scheduled to undergo surgery at Memorial Sloan-Kettering Cancer Center. Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer
- What is being tested?
- celecoxib, therapeutic conventional surgery and pharmacological study
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Feb 2010
- Phase
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed invasive breast carcinoma
- Tumor at least 1 cm by radiologic estimate or physical exam
- No disease limited to ductal carcinoma in situ only
- Planning to undergo surgery at Memorial Sloan-Kettering Cancer Center
- Hormone receptor status:
- Not specified
Show all 34Show fewer
- Female
- Postmenopausal as defined by at least 1 of the following:
- No menstrual period within the past 12 months
- Prior bilateral oophorectomy
- No known liver disease
- No renal insufficiency
- No congestive heart failure
- No coronary artery disease
- No history of documented peptic ulcer disease
- No gastritis
- No medical condition that would preclude definitive surgery
- No allergy to NSAIDs or sulfa-containing drugs
- No connective tissue diseases, including any of the following:
- Systemic lupus erythematosus
- Reynaud's disease
- Scleroderma
- More than 3 months since prior chemotherapy
- More than 2 weeks since prior hormone replacement therapy
- More than 2 weeks since prior tamoxifen
- More than 2 weeks since prior aromatase inhibitors
- More than 2 weeks since prior raloxifene
- More than 2 weeks since prior steroids
- More than 1 week since prior nonsteroidal anti-inflammatory drugs (NSAIDs)
- More than 1 week since prior cyclooxygenase (COX)-2 inhibitors
- No concurrent warfarin
- No concurrent thiazide or loop diuretics
- No concurrent COX-2 inhibitors
- No concurrent NSAIDs
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: An Exploratory, Open-Label Phase I Pharmacodynamic Study of COX-2 Inhibition With Celecoxib (Celebrex) and Aromatase Activity in Breast Cancer
This randomized phase I trial is studying the side effects of celecoxib in treating postmenopausal women with invasive breast cancer who are scheduled to undergo surgery at Memorial Sloan-Kettering Cancer Center. Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine whether celecoxib suppresses aromatase activity in postmenopausal women with invasive breast cancer planning to undergo surgery.
SECONDARY OBJECTIVES:
- Correlate celecoxib-mediated inhibition of aromatase activity with levels of cyclooxygenase (COX)-2 and HER-2/neu and estrogen receptor status in these patients.
II. Determine the effect of this drug on histology, Ki67, RNA expression profile by microarray analysis, PI3-K, AKT and ERK1/2 MAP kinase activities, and PGE_2 levels in these patients.
III. Determine whether any observed biological effect of this drug is dose-dependent in these patients.
IV. Identify collateral targets (COX-2-independent) of this drug in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.
Arm I: Patients receive oral celecoxib twice daily for 1-3 weeks (according to the duration between biopsy and surgery) in the absence of unacceptable toxicity.
Arm II: Patients receive a higher dose of oral celecoxib as in arm I.
Arm III: Patients do not receive treatment.
All patients undergo definitive surgery.
PROJECTED ACCRUAL: A total of 75 patients (25 per treatment arm) will be accrued for this study within 2-3 years.
- Conditions
- Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
- Being tested
- celecoxib, therapeutic conventional surgery, pharmacological study, laboratory biomarker analysis
- 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, SC-58635
Given orally
therapeutic conventional surgeryProcedure or surgery
Undergo surgery
Also called pharmacological studies
Correlative studies
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (celecoxib) | Experimental | Patients receive oral celecoxib twice daily for 1-3 weeks (according to the duration between biopsy and surgery) in the absence of unacceptable toxicity. Receives: Drug: celecoxib; Procedure: therapeutic conventional surgery; Other: pharmacological study; Other: laboratory biomarker analysis |
| Arm II (high-dose celecoxib) | Experimental | Patients receive a higher dose of oral celecoxib as in arm I. Receives: Drug: celecoxib; Procedure: therapeutic conventional surgery; Other: pharmacological study; Other: laboratory biomarker analysis |
| Arm III (surgery) | Active comparator | Patients do not receive treatment. All patients undergo surgery. Receives: Procedure: therapeutic conventional surgery; Other: pharmacological study; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in aromatase activity levels
Measured: From baseline to post-surgery
Secondary outcomes (3)
Change in cell proliferation via a marker Ki67 between treatment arms by immunohistochemistry
Measured: From baseline to post-treatment
Correlation between aromatase activity and levels of COX 2 protein, HER 2/neu and ER status in surgical specimens
Measured: At post-treatment/surgery
Effect of treatment vs. no treatment on gene expression (mRNA) profile by microarray, kinase activities (PI3, AKT and ERK1/2 MAP kinases) and PGE2 levels
Measured: At post-treatment/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2003 (estimated)
- Study startApr 2003
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage I Breast CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Elisa Port, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00070057
- Sponsor's protocol ID
- NCI-2012-01441
- Other IDs
- NCI-2012-01441, CDR0000329919, MSKCC-03027, N01-CN-35112, P30CA008748, N01CN35112
- Status last verified
- Dec 2016
- First submitted
- 3 Oct 2003
- Last updated
- 29 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Open-Label Phase I Pharmacodynamic Study of COX-2 Inhibition With Celecoxib (Celebrex) and Aromatase Activity in Breast Cancer
- ClinicalTrials.gov ID
- NCT00070057
- Acronym / sponsor ID
- NCI-2012-01441
- Conditions
- Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Apr 2003
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 7 Oct 2003 (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.
This randomized phase I trial is studying the side effects of celecoxib in treating postmenopausal women with invasive breast cancer who are scheduled to undergo surgery at Memorial Sloan-Kettering Cancer Center. Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
Detailed description
PRIMARY OBJECTIVES:
- Determine whether celecoxib suppresses aromatase activity in postmenopausal women with invasive breast cancer planning to undergo surgery.
SECONDARY OBJECTIVES:
- Correlate celecoxib-mediated inhibition of aromatase activity with levels of cyclooxygenase (COX)-2 and HER-2/neu and estrogen receptor status in these patients.
II. Determine the effect of this drug on histology, Ki67, RNA expression profile by microarray analysis, PI3-K, AKT and ERK1/2 MAP kinase activities, and PGE_2 levels in these patients.
III. Determine whether any observed biological effect of this drug is dose-dependent in these patients.
IV. Identify collateral targets (COX-2-independent) of this drug in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.
Arm I: Patients receive oral celecoxib twice daily for 1-3 weeks (according to the duration between biopsy and surgery) in the absence of unacceptable toxicity.
Arm II: Patients receive a higher dose of oral celecoxib as in arm I.
Arm III: Patients do not receive treatment.
All patients undergo definitive surgery.
PROJECTED ACCRUAL: A total of 75 patients (25 per treatment arm) will be accrued for this study within 2-3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (celecoxib) | Experimental | Drug: celecoxib, Procedure: therapeutic conventional surgery, Other: pharmacological study, Other: laboratory biomarker analysisPatients receive oral celecoxib twice daily for 1-3 weeks (according to the duration between biopsy and surgery) in the absence of unacceptable toxicity. |
| Arm II (high-dose celecoxib) | Experimental | Drug: celecoxib, Procedure: therapeutic conventional surgery, Other: pharmacological study, Other: laboratory biomarker analysisPatients receive a higher dose of oral celecoxib as in arm I. |
| Arm III (surgery) | Active comparator | Procedure: therapeutic conventional surgery, Other: pharmacological study, Other: laboratory biomarker analysisPatients do not receive treatment. All patients undergo surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- Histologically confirmed invasive breast carcinoma
- Planning to undergo surgery at Memorial Sloan-Kettering Cancer Center
- Hormone receptor status:
- Female
- Postmenopausal as defined by at least 1 of the following:
Key exclusion criteria (0 listed)
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: Celebrex, SC-58635Given orally | Drug | Arm I (celecoxib), Arm II (high-dose celecoxib) |
| therapeutic conventional surgeryUndergo surgery | Procedure or surgery | Arm I (celecoxib), Arm II (high-dose celecoxib), Arm III (surgery) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Arm I (celecoxib), Arm II (high-dose celecoxib), Arm III (surgery) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (celecoxib), Arm II (high-dose celecoxib), Arm III (surgery) |
Primary outcome
Change in aromatase activity levels
Time frame: From baseline to post-surgery
3 secondary outcomes
Change in cell proliferation via a marker Ki67 between treatment arms by immunohistochemistry
Time frame: From baseline to post-treatment
Correlation between aromatase activity and levels of COX 2 protein, HER 2/neu and ER status in surgical specimens
Time frame: At post-treatment/surgery
Effect of treatment vs. no treatment on gene expression (mRNA) profile by microarray, kinase activities (PI3, AKT and ERK1/2 MAP kinases) and PGE2 levels
Time frame: At post-treatment/surgery
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 Dec 2016.
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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.
Elisa Port principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing celecoxib, therapeutic conventional surgery and pharmacological study in people with Stage I Breast Cancer and Stage II Breast Cancer, run by National Cancer Institute (NCI) 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 34 inclusion and 0 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 Dec 2016. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 aromatase activity levels (time frame: From baseline to post-surgery). 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 Dec 2016.