Breast CancerPhase 2NCT00291694
Protocol for Women at Increased Risk of Developing Breast Cancer
A Phase 2 study testing celecoxib in people with Breast Cancer, run by Carol Fabian, MD at 1 site in United States.
Trial summary
To assess the effects of twelve months of celecoxib administration by evaluating breast tissue needle aspirations, to determine if cell growth can be slowed. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- 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
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Dec 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women who have a high risk of breast cancer
- older than 18 years
Who cannot join
- anticoagulants
- marked breast tenderness
- pregnant or within twelve months of breast feeding/childbirth
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: A Double-blinded Phase II Study of the Expression of Ki-67/MIB-1 in Women With Hyperplasia of the Breast Randomized to Receive Daily Celecoxib 400 mg BID or Placebo
To assess the effects of twelve months of celecoxib administration by evaluating breast tissue needle aspirations, to determine if cell growth can be slowed.
Read the detailed description
A blind randomized study of celecoxib in women at high risk of developing breast cancer. Subjects are to take twelve months of drug/placebo. At baseline and after twelve months subjects will have a random periareolar fine needle breast aspiration that will be assessed for epithelial cell growth and other markers of risk. Baseline and twelve month serum samples will also be assessed for hormones and growth factors which may be associated with breast cancer risk. Mammograms at baseline and twelve months will also be assessed for breast density changes.
- Conditions
- Breast Cancer
- Being tested
- celecoxib, placebo
- Keywords
- breast atypia, double-blind randomized clinical trial, RCT, celecoxib, COX-2 inhibitor, placebo, high risk for breast cancer, breast epithelial hyperplasia, ki-67, chemoprevention
- 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 400 mg BID
placeboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Oral Celecoxib 400 mg twice daily for 12 months Receives: Drug: celecoxib |
| 2 | Placebo comparator | Matched blinded placebo twice daily for 12 months Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percent of Breast Epithelial Cells Staining Positive for Ki-67
Immunocytochemical staining of breast epithelial cells. Positive cells reflect proliferative activity.
Measured: Baseline and 12 months
Secondary outcomes (4)
Mammographic Breast Density
The percent of mammographic breast area that is considered to be at increased density. Evaluated using the semi-automated computer program Cumulus.
Measured: Baseline and 12 months
Serum Estradiol Concentration
Change in serum estradiol concentration
Measured: Baseline to 12 months
Serum Sex Hormone Binding Globulin (SHBG) Concentration
Change in serum concentration
Measured: Baseline to 12 months
Molecular Ratio of Serum Concentration of IGF-1 to IGFBP3
Change ion ratio.
Measured: baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2006 (estimated)
- Study startApr 2003
- Primary completionDec 2009
- Study completionDec 2009
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.
- 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carol Fabian, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation
- Responsible party
- Sponsor-investigator, Carol Fabian, MD, University of Kansas Medical Center
- Investigators
- Carol J Fabian, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00291694
- Sponsor's protocol ID
- 9118
- Status last verified
- Sep 2016
- First submitted
- 10 Feb 2006
- Last updated
- 7 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded Phase II Study of the Expression of Ki-67/MIB-1 in Women With Hyperplasia of the Breast Randomized to Receive Daily Celecoxib 400 mg BID or Placebo
- ClinicalTrials.gov ID
- NCT00291694
- Acronym / sponsor ID
- 9118
- Conditions
- Breast Cancer
- Keywords
- breast atypia, double-blind randomized clinical trial, RCT, celecoxib, COX-2 inhibitor, placebo, high risk for breast cancer, breast epithelial hyperplasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Carol Fabian, MDUniversity, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation
- Study start
- Apr 2003
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 14 Feb 2006 (estimated)
- Results
- Posted 5 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the effects of twelve months of celecoxib administration by evaluating breast tissue needle aspirations, to determine if cell growth can be slowed.
Detailed description
A blind randomized study of celecoxib in women at high risk of developing breast cancer. Subjects are to take twelve months of drug/placebo. At baseline and after twelve months subjects will have a random periareolar fine needle breast aspiration that will be assessed for epithelial cell growth and other markers of risk. Baseline and twelve month serum samples will also be assessed for hormones and growth factors which may be associated with breast cancer risk. Mammograms at baseline and twelve months will also be assessed for breast density changes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: celecoxibOral Celecoxib 400 mg twice daily for 12 months |
| 2 | Placebo comparator | Other: placeboMatched blinded placebo twice daily for 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- women who have a high risk of breast cancer
- older than 18 years
Key exclusion criteria (3 listed)
- anticoagulants
- marked breast tenderness
- pregnant or within twelve months of breast feeding/childbirth
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 400 mg BID | Drug | 1 |
| placeboplacebo | Other | 2 |
Primary outcome
Change in Percent of Breast Epithelial Cells Staining Positive for Ki-67
Time frame: Baseline and 12 months
Immunocytochemical staining of breast epithelial cells. Positive cells reflect proliferative activity.
4 secondary outcomes
Mammographic Breast Density
Time frame: Baseline and 12 months
Serum Estradiol Concentration
Time frame: Baseline to 12 months
Serum Sex Hormone Binding Globulin (SHBG) Concentration
Time frame: Baseline to 12 months
Molecular Ratio of Serum Concentration of IGF-1 to IGFBP3
Time frame: baseline to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Carol J Fabian, MD principal investigator
University of Kansas Medical Center
1 site 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 Carol Fabian, MD 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 2 inclusion and 3 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 7 Nov 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. 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 5 Sep 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?
Change in Percent of Breast Epithelial Cells Staining Positive for Ki-67 (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?
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 7 Nov 2016.