Breast CancerPhase 2NCT00088972
S0300, Celecoxib in Preventing Breast Cancer in Premenopausal Women
A Phase 2 study testing celecoxib in people with Breast Cancer, run by SWOG Cancer Research Network at 9 sites in United States.
Trial summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be effective in preventing breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 9 sitesUnited States
- Study dates
- Nov 2004to Jul 2009
- 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 18 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- At elevated risk of developing breast cancer, as defined by 1 of the following:
- Modified Gail risk at 5 years ≥ 1.7% or lifetime risk ≥ 20% AND Claus Model, BRCAPro Model, or Tyrer-Cuzick Model lifetime risk ≥ 20%
- Diagnosis of lobular carcinoma in situ or ductal carcinoma in situ
- Known deleterious mutation of BRCA1 or BRCA2
- At least 1 breast available for imagery and biopsy
- Has undergone a baseline mammogram with a standard density wedge within 7-14 days after completion of the last menstrual period AND within 7 days before study entry
- Mammogram normal or benign (BIRADS score 0 or 1)
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Female
Menopausal status
- Premenopausal, defined by 1 of the following criteria:
- Last menstrual period < 6 months ago AND no prior bilateral ovariectomy AND not on estrogen replacement therapy
- Prior hysterectomy (with ovaries still in place) AND normal follicle-stimulating hormone levels within 28 days of study entry
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Bilirubin < 2.0 times institutional upper limit of normal (IULN)
- SGOT or SGPT < 2 times IULN
- Alkaline phosphatase < 2 times IULN
- INR ≤ 1.5
- PT and PTT ≤ IULN
Renal
- Serum creatinine < 2.0 times IULN
Cardiovascular
- No history of myocardial infarction
- No angina pectoris
- No known coronary artery disease
- No history of stroke or mini-stroke (e.g., transient ischemic attack)
- No history of thromboembolic disease (e.g., deep vein thrombosis or pulmonary embolism)
- No uncontrolled hypertension (i.e., blood pressure > 140/90 mmHg)
Pulmonary
- No asthma after taking aspirin or other NSAIDs
Other
- No known sensitivity to celecoxib
- No allergy to sulfonamides
- No urticaria or allergic-type reactions after taking aspirin or other NSAIDs
- No extreme lactose intolerance
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or early bladder cancer (preinvasive transitional cell carcinoma of the bladder)
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 5 years since prior biologic therapy for cancer
Chemotherapy
- More than 5 years since prior chemotherapy for cancer
Endocrine therapy
- At least 28 days since prior tamoxifen
- No prior systemic estrogen modifiers (SERMs) or aromatase inhibitors
- Concurrent hormonal contraception (i.e., pills, patches, or shots) allowed provided contraception was initiated prior to study entry
Radiotherapy
- No prior radiotherapy to the breast to be studied
Surgery
- Not specified
Other
- At least 7 days since prior anticoagulant therapy
- More than 1 month since prior chronic daily aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) of more than 7 days duration
- Concurrent intermittent aspirin or NSAIDs allowed (no more than 10 days per month)
- No concurrent participation in another clinical trial for treatment or prevention of cancer unless no longer receiving treatment and is in the follow-up phase
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87131-5636
Glendale Memorial Hospital Comprehensive Cancer Center
Glendale, California, 91204
Baylor University Medical Center - Houston
Houston, Texas, 77030
Ben Taub General Hospital
Houston, Texas, 77030
Methodist Hospital
Houston, Texas, 77030
St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
Houston, Texas, 77030
Veterans Affairs Medical Center - Houston
Houston, Texas, 77030
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, 98122-4307
University Cancer Center at University of Washington Medical Center
Seattle, Washington, 98195-6043
About this study
Official title: Randomized Placebo-Controlled Biomarker Modulation Trial Using Celecoxib in Premenopausal Women at High Risk for Breast Cancer
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be effective in preventing breast cancer.
PURPOSE: This randomized phase II trial is studying how well celecoxib works in preventing breast cancer in premenopausal women who are at risk for developing the disease.
Read the detailed description
OBJECTIVES:
- Compare 1-year mammographic density in premenopausal women at high risk for developing breast cancer treated with celecoxib vs placebo.
- Compare 1-year proliferation of breast epithelial cells, as measured by Ki67 staining, in patients treated with these drugs.
- Compare the expression of other biomarkers, including cyclo-oxygenase-2 (COX-2) enzyme and a marker of apoptosis, in breast tissue of patients treated with these drugs.
- Compare 1-year plasma levels of insulin-like growth factor (IGF)-1, IGF binding protein-3, and prostaglandin E_2 in patients treated with these drugs.
- Compare the toxicity of these drugs in these patients.
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to risk category (lobular carcinoma in situ or ductal carcinoma in situ vs BRCA1/2 mutation AND any Gail risk vs Gail risk ≥1.7% but < 5% vs Gail risk ≥ 5%) and prior tamoxifen use (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Celocoxib: Patients receive oral celecoxib twice daily.
- Placebo: Patients receive oral placebo twice daily. In both arms, treatment continues for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
Patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- celecoxib, placebo
- Keywords
- breast cancer, breast cancer in situ, lobular breast carcinoma in situ, ductal breast carcinoma
- Medical subject headings
- Breast Neoplasms, Breast Carcinoma In Situ, Carcinoma, Ductal, Breast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celecoxibDrug
Given orally
placeboOther
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Arm I - Celecoxib | Experimental | Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer. Receives: Drug: celecoxib |
| Arm II - Placebo | Placebo comparator | Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mammographic Density
The primary outcome measure is change in mammographic density. The null hypothesis is that there is no difference between the arms in change in mammographic density over one year versus the alternative that the treatment arm reduces mammographic density by 10 points (percent of pixels highlighted) or more over one year compared to the change in the placebo arm.
Measured: 1 year
Secondary outcomes (1)
Ki-67 Expression
The difference between the two arms in the percent of patients with non-zero ki-67 expression over the two time periods (baseline and 1-year).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2004 (estimated)
- Study startNov 2004
- Primary completionJul 2009
- Study completionJul 2009
Why it stopped: Study closed due to poor accrual.
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.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Powel H. Brown, MD, PhD, Study chair, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00088972
- Sponsor's protocol ID
- CDR0000377698
- Other IDs
- U10CA012027, S0300, U10CA037429
- Status last verified
- Jul 2018
- First submitted
- 4 Aug 2004
- Last updated
- 10 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo-Controlled Biomarker Modulation Trial Using Celecoxib in Premenopausal Women at High Risk for Breast Cancer
- ClinicalTrials.gov ID
- NCT00088972
- Acronym / sponsor ID
- CDR0000377698
- Conditions
- Breast Cancer
- Keywords
- breast cancer, breast cancer in situ, lobular breast carcinoma in situ, ductal breast carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed due to poor accrual.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2004
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 5 Aug 2004 (estimated)
- Results
- Posted 9 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be effective in preventing breast cancer.
PURPOSE: This randomized phase II trial is studying how well celecoxib works in preventing breast cancer in premenopausal women who are at risk for developing the disease.
Detailed description
OBJECTIVES:
- Compare 1-year mammographic density in premenopausal women at high risk for developing breast cancer treated with celecoxib vs placebo.
- Compare 1-year proliferation of breast epithelial cells, as measured by Ki67 staining, in patients treated with these drugs.
- Compare the expression of other biomarkers, including cyclo-oxygenase-2 (COX-2) enzyme and a marker of apoptosis, in breast tissue of patients treated with these drugs.
- Compare 1-year plasma levels of insulin-like growth factor (IGF)-1, IGF binding protein-3, and prostaglandin E_2 in patients treated with these drugs.
- Compare the toxicity of these drugs in these patients.
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to risk category (lobular carcinoma in situ or ductal carcinoma in situ vs BRCA1/2 mutation AND any Gail risk vs Gail risk ≥1.7% but < 5% vs Gail risk ≥ 5%) and prior tamoxifen use (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Celocoxib: Patients receive oral celecoxib twice daily.
- Placebo: Patients receive oral placebo twice daily. In both arms, treatment continues for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
Patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I - Celecoxib | Experimental | Drug: celecoxibPatients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer. |
| Arm II - Placebo | Placebo comparator | Other: placeboPatients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| celecoxibGiven orally | Drug | Arm I - Celecoxib |
| placeboGiven orally | Other | Arm II - Placebo |
Primary outcome
Mammographic Density
Time frame: 1 year
The primary outcome measure is change in mammographic density. The null hypothesis is that there is no difference between the arms in change in mammographic density over one year versus the alternative that the treatment arm reduces mammographic density by 10 points (percent of pixels highlighted) or more over one year compared to the change in the placebo arm.
1 secondary outcome
Ki-67 Expression
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Powel H. Brown, MD, PhD study chair
Baylor College of Medicine
9 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 celecoxib in people with Breast Cancer, run by SWOG Cancer Research Network at 9 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?
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: stopped early, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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. Some participants in this study may receive a placebo. 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 9 Apr 2013). 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?
Mammographic Density (time frame: 1 year). 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 10 Aug 2018.