Metastatic Breast CancerPhase 3NCT00525096
Exemestane + Celecoxib vs Exemestane + Placebo in Metastatic Breast Cancer
A Phase 3 study testing Celecoxib and Exemestane in people with Metastatic Breast Cancer, run by ARCAGY/ GINECO GROUP.
Trial summary
To discover if the adding of a coxib increases the efficacy of the Aromasine. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Celecoxib and Exemestane
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- No sites listed yet
- Study dates
- Jul 2003to Dec 2004
- Phase
- Phase 3
- 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
- Femal patient aged > 18 years
- Histologically proven breast cancer
- Menopausal patient according to the following definition:
- amenorrhoea > 1 year or menopause affirmed by a rate of oestradiol or hypophyseal gonadotrophin
- surgical ovariectomy
- treatment by LHRH analog
Show all 18Show fewer
- ovarian suppression by radiotherapy
- amenorrhoea induced by chemotherapy > 1 year
- Oestradiol and/or progesterone positive receptors
- Presence of one or several metastatic lesion:
- mesurable lesion
- bone metastase were detected by bone scintigraphy
- Patient who can have received:
- Adjuvant chemotherapy and/or hormonotherapy (Tamoxifen)
- Metastatic Treatment by chemotherapy
- PS < 2
- Adequate biological values
- Patient who has clearly given her consent by signing on informed consent form prior to participation
Who cannot join
- Patient previously treated with hormonotherapy in metastatic phase
- Antecedent of treatment with aromatase inhibitors
- local relapse (with the exception of cutaneous thoracic nodes)
- Patient with only one metastatic lesion like: pleurisy , ascites, lung Lymphangitis carcinomatosa
About this study
Official title: A Multicenter Randomized Phase III, Double-blind Study Comparing Efficacy of the Association of Exemestane and Celecoxib Versus Exemestane and Placebo in Menopausal Patients With Metastatic Breast Cancer.
To discover if the adding of a coxib increases the efficacy of the Aromasine.
- Conditions
- Metastatic Breast Cancer
- Being tested
- placebo, Celecoxib, Exemestane
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
2 tablets twice a day per os
CelecoxibDrug
Also called Celebrex
2*200 mg tablets twice a day per os
ExemestaneDrug
Also called Aromasin
Exemestane 25 mg per day per os
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Aromasin + placebo in place of Celebrex Receives: Drug: placebo; Drug: Exemestane |
| Celebrex | Experimental | Aromasin + Celebrex Receives: Drug: Celecoxib; Drug: Exemestane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: 5 years
Secondary outcomes (4)
Objective response rate
Measured: 6 months
Quality Of Life + pain
Measured: 6 months
Overall survival
Measured: 5 years
Tolerance
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startJul 2003
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCAGY/ GINECO GROUP
- Sponsor type
- University, hospital or other
- Investigators
- Gilles FREYER, PhD, Principal investigator, Centre Hospitalier Lyon Sud - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525096
- Sponsor's protocol ID
- CELAROM
- Status last verified
- Jun 2011
- First submitted
- 3 Sep 2007
- Last updated
- 30 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Phase III, Double-blind Study Comparing Efficacy of the Association of Exemestane and Celecoxib Versus Exemestane and Placebo in Menopausal Patients With Metastatic Breast Cancer.
- ClinicalTrials.gov ID
- NCT00525096
- Acronym / sponsor ID
- CELAROM
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- ARCAGY/ GINECO GROUPUniversity, hospital or other
- Study start
- Jul 2003
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 5 Sep 2007 (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.
To discover if the adding of a coxib increases the efficacy of the Aromasine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: placebo, Drug: ExemestaneAromasin + placebo in place of Celebrex |
| Celebrex | Experimental | Drug: Celecoxib, Drug: ExemestaneAromasin + Celebrex |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Femal patient aged > 18 years
- Histologically proven breast cancer
- Menopausal patient according to the following definition:
- Oestradiol and/or progesterone positive receptors
- Presence of one or several metastatic lesion:
Key exclusion criteria (4 listed)
- Patient previously treated with hormonotherapy in metastatic phase
- Antecedent of treatment with aromatase inhibitors
- local relapse (with the exception of cutaneous thoracic nodes)
- Patient with only one metastatic lesion like: pleurisy , ascites, lung Lymphangitis carcinomatosa
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 |
|---|---|---|
| placebo2 tablets twice a day per os | Drug | Placebo |
| CelecoxibAlso: Celebrex2*200 mg tablets twice a day per os | Drug | Celebrex |
| ExemestaneAlso: AromasinExemestane 25 mg per day per os | Drug | Celebrex, Placebo |
Primary outcome
Progression free survival
Time frame: 5 years
4 secondary outcomes
Objective response rate
Time frame: 6 months
Quality Of Life + pain
Time frame: 6 months
Overall survival
Time frame: 5 years
Tolerance
Time frame: 6 months
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 30 Jun 2011.
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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.
Gilles FREYER, PhD principal investigator
Centre Hospitalier Lyon Sud - France
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Celecoxib and Exemestane in people with Metastatic Breast Cancer, run by ARCAGY/ GINECO GROUP.
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 18 inclusion and 4 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 30 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Progression free survival (time frame: 5 years). 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 30 Jun 2011.