Breast NeoplasmsPhase 2NCT01695226
Randomized Controlled Phase II Trial of Pre-operative Celecoxib Treatment in Breast Cancer
A Phase 2 study testing celecoxib in people with Breast Neoplasms and Breast Cancer, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Cyclooxygenase-2 (COX-2) is frequently over-expressed in primary breast cancer. There is evidence that COX-2 inhibition exerts anti-tumor effects in breast cancer. To further determine the effect of COX-2 inhibition in primary breast cancer, we aimed at studying the changes in breast cancer tissues of patients treated… Read more about this study
- Who is it for?
- Ages 18 to 74 years, women only
- Conditions the study is for
- Breast Neoplasms, Breast Cancer
- What is being tested?
- celecoxib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteNetherlands
- Study dates
- Feb 2004to Jul 2007
- Phase
- Phase 2
- 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 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients suspected of having invasive breast cancer, >1 cm in diameter, and in whom there is an indication for a core or incision biopsy
- Age <75 years at time of diagnosis
- Patient willing and able to comply with the study prescriptions
- Patient able to give written informed consent before patient registration/randomisation
- Pre- and post-menopausal patients are eligible
- Hormone receptor positive and negative patients are eligible
- A negative pregnancy test in pre-menopausal women
Who cannot join
- HIV, HBV or HCV positivity
- Known hypersensitivity to NSAIDs
- A history of upper gastro-intestinal bleeding
- Endoscopically proven upper gastro-intestinal ulceration
- Patients using NSAIDs, including salicyclic acid
- Systemic use of corticosteroids
- A history or the presence of any other malignancy excepting adequately treated squamous cell skin cancer or in situ carcinoma of the cervix
- Patients who have been treated with neo-adjuvant chemotherapy or hormone therapy
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Hospital Maastricht
Maastricht, Limburg, 6229 HX
About this study
Cyclooxygenase-2 (COX-2) is frequently over-expressed in primary breast cancer. There is evidence that COX-2 inhibition exerts anti-tumor effects in breast cancer. To further determine the effect of COX-2 inhibition in primary breast cancer, we aimed at studying the changes in breast cancer tissues of patients treated with the selective COX-2 inhibitor celecoxib.
In a single-centre double-blinded phase II study, breast cancer patients were randomised to receive either pre-operative celecoxib (400 mg) or placebo twice daily for two to three weeks. We collected fresh-frozen pre-surgical biopsies (before treatment) and surgical excision specimens (after treatment) to assess the tumor changes by use a cDNA microarray, which allows to study the genome-wide changes at the transcriptional level.
- Conditions
- Breast Neoplasms, Breast Cancer
- Being tested
- celecoxib, Placebo
- Keywords
- Celecoxib, Clinical trial, Phase II, Oligonucleotide Array Sequence 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
pre-operative celecoxib (400 mg) twice daily for two to three weeks
PlaceboDrug
pre-operative placebo twice daily for two to three weeks
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | pre-operative placebo twice daily for two to three weeks Receives: Drug: Placebo |
| celecoxib | Experimental | pre-operative celecoxib (400 mg) twice daily for two to three weeks Receives: Drug: celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
whole-genome expression after celecoxib treatment
Affymetrix arrays were performed on pre- and post treated (celecoxib and placebo) breast cancer tissues
Secondary outcomes (1)
Percent change of Ki-67 protein positivity in celecoxib-treated breast cancer tissues versus placebo-treated tissues
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startFeb 2004
- Primary completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre SJ Hupperets, MD; PhD, Principal investigator, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695226
- Sponsor's protocol ID
- MUMC MEC 04-038
- Status last verified
- Sep 2012
- First submitted
- 25 Sep 2012
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Brandao RD, Veeck J, Van de Vijver KK, Lindsey P, de Vries B, van Elssen CH, Blok MJ, Keymeulen K, Ayoubi T, Smeets HJ, Tjan-Heijnen VC, Hupperets PS. A randomised controlled phase II trial of pre-operative celecoxib treatment reveals anti-tumour transcriptional response in primary breast cancer. Breast Cancer Res. 2013 Apr 8;15(2):R29. doi: 10.1186/bcr3409.
PubMed 23566419
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Phase II Trial of Pre-operative Celecoxib Treatment in Breast Cancer
- ClinicalTrials.gov ID
- NCT01695226
- Acronym / sponsor ID
- MUMC MEC 04-038
- Conditions
- Breast Neoplasms, Breast Cancer
- Keywords
- Celecoxib, Clinical trial, Phase II, Oligonucleotide Array Sequence Analysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Jul 2007 (actual)
- First posted
- 27 Sep 2012 (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.
Cyclooxygenase-2 (COX-2) is frequently over-expressed in primary breast cancer. There is evidence that COX-2 inhibition exerts anti-tumor effects in breast cancer. To further determine the effect of COX-2 inhibition in primary breast cancer, we aimed at studying the changes in breast cancer tissues of patients treated with the selective COX-2 inhibitor celecoxib.
In a single-centre double-blinded phase II study, breast cancer patients were randomised to receive either pre-operative celecoxib (400 mg) or placebo twice daily for two to three weeks. We collected fresh-frozen pre-surgical biopsies (before treatment) and surgical excision specimens (after treatment) to assess the tumor changes by use a cDNA microarray, which allows to study the genome-wide changes at the transcriptional level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Placebopre-operative placebo twice daily for two to three weeks |
| celecoxib | Experimental | Drug: celecoxibpre-operative celecoxib (400 mg) twice daily for two to three weeks |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female patients suspected of having invasive breast cancer, >1 cm in diameter, and in whom there is an indication for a core or incision biopsy
- Age <75 years at time of diagnosis
- Patient willing and able to comply with the study prescriptions
- Patient able to give written informed consent before patient registration/randomisation
- Pre- and post-menopausal patients are eligible
Key exclusion criteria (8 listed)
- HIV, HBV or HCV positivity
- Known hypersensitivity to NSAIDs
- A history of upper gastro-intestinal bleeding
- Endoscopically proven upper gastro-intestinal ulceration
- Patients using NSAIDs, including salicyclic acid
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: celebrexpre-operative celecoxib (400 mg) twice daily for two to three weeks | Drug | celecoxib |
| Placebopre-operative placebo twice daily for two to three weeks | Drug | placebo |
Primary outcome
whole-genome expression after celecoxib treatment
Affymetrix arrays were performed on pre- and post treated (celecoxib and placebo) breast cancer tissues
1 secondary outcome
Percent change of Ki-67 protein positivity in celecoxib-treated breast cancer tissues versus placebo-treated tissues
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 9 Jan 2018.
- Results publication: PubMed 23566419Brandao RD, Veeck J, Van de Vijver KK, Lindsey P, de Vries B, van Elssen CH, Blok MJ, Keymeulen K, Ayoubi T, Smeets HJ, Tjan-Heijnen VC, Hupperets PS. A randomised controlled phase II trial of pre-operative celecoxib treatment reveals anti-tumour transcriptional response in primary breast cancer. Breast Cancer Res. 2013 Apr 8;15(2):R29. doi: 10.1186/bcr3409.
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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.
Pierre SJ Hupperets, MD; PhD principal investigator
Maastricht University Medical Centre
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 Neoplasms and Breast Cancer, run by Maastricht University Medical Center at 1 site in Netherlands.
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 7 inclusion and 8 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 9 Jan 2018. 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 Netherlands. 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?
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?
whole-genome expression after celecoxib treatment. 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 NCT01695226, 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 9 Jan 2018.