Breast NeoplasmsPhase 4NCT00649090
A Study to Evaluate the Safety of Adjuvant Treatment With Exemestane Following Previous Treatment With Tamoxifen in Postmenopausal Women With Estrogen Sensitive Primary Breast Cancer
A Phase 4 study testing exemestane in people with Breast Neoplasms, run by Pfizer at 61 sites in Belgium.
Trial summary
The purpose of this study was to give access to postmenopausal women with estrogen sensitive primary breast cancer to exemestane for the adjuvant treatment of breast cancer after the use of tamoxifen and to collect all serious adverse events. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- exemestane
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,549 participants
- Where
- 61 sitesBelgium
- Study dates
- Mar 2005to Apr 2007
- Phase
- Phase 4
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Postmenopausal patients
- Patients with early breast cancer after adequate loco-regional treatment and eventual adjuvant chemotherapy, treated with tamoxifen for 2-3 years OR treated with tamoxifen for 2-3 years and consecutive exemestane treatment, provided the total duration of endocrine treatment is less than 5 years
- Estrogen receptor positive breast cancer patients
- Patients who remain free from disease following treatment with tamoxifen
Who cannot join
- Patients taking other drugs for the adjuvant treatment of breast cancer
- Patients taking hormone replacement therapy
- Donation of blood or blood products for transfusion during the 30 days prior to initiation of treatment with study drug, at any time during the program or 30 days after completion of treatment
Trial locations and contacts
61 sites in 1 country.
61 sites in 1 country
Belgium61 sites
Pfizer Investigational Site
Aalst, 9300
Pfizer Investigational Site
Antwerp, 2020
Pfizer Investigational Site
Arlon, 6700
Pfizer Investigational Site
Baudour, 7331
Pfizer Investigational Site
Bonheiden, 2820
Pfizer Investigational Site
Bouge, 5004
Pfizer Investigational Site
Boussu, 7300
Pfizer Investigational Site
Braine-l'Alleud, 1420
Pfizer Investigational Site
Brasschaat, 2930
Pfizer Investigational Site
Bruges, 8000
Pfizer Investigational Site
Brussels, 1000
Pfizer Investigational Site
Brussels, 1020
Pfizer Investigational Site
Brussels, 1040
Pfizer Investigational Site
Brussels, 1050
Pfizer Investigational Site
Brussels, 1070
Pfizer Investigational Site
Brussels, 1180
Pfizer Investigational Site
Brussels, 1200
Pfizer Investigational Site
Brussels, 1210
Pfizer Investigational Site
Brussels, B-1040
Pfizer Investigational Site
Charleroi, 6000
Pfizer Investigational Site
Chênée, 4032
Pfizer Investigational Site
Chimay, 6460
Pfizer Investigational Site
Dendermonde, 9200
Pfizer Investigational Site
Duffel, 2570
Pfizer Investigational Site
Edegem, 2650
Pfizer Investigational Site
Eupen, 4700
Pfizer Investigational Site
Genk, 3600
Pfizer Investigational Site
Ghent, 9000
Pfizer Investigational Site
Gilly (Charleroi), 6060
Pfizer Investigational Site
Gosselies, 6041
Pfizer Investigational Site
Halle, 1500
Pfizer Investigational Site
Hasselt, 3500
Pfizer Investigational Site
Herstal, 4040
Pfizer Investigational Site
Hornu, 7301
Pfizer Investigational Site
Huy, 4500
Pfizer Investigational Site
Kortrijk, 8500
Pfizer Investigational Site
La Louvière, 7100
Pfizer Investigational Site
Leuven, 3000
Pfizer Investigational Site
Libramont, 6800
Pfizer Investigational Site
Liège, 4000
Pfizer Investigational Site
Lier, 2500
Pfizer Investigational Site
Mechelen, 2800
Pfizer Investigational Site
Merksem, 2170
Pfizer Investigational Site
Mons, 7000
Pfizer Investigational Site
Montigny-le-Tilleul, 6110
Pfizer Investigational Site
Mouscron, 7700
Pfizer Investigational Site
Namur, 5000
Pfizer Investigational Site
Ottignies, 1340
Pfizer Investigational Site
Rocourt, 4000
Pfizer Investigational Site
Roeselare, 8800
Pfizer Investigational Site
Seraing, 4100
Pfizer Investigational Site
Sint-Niklaas, 9100
Pfizer Investigational Site
Soignies, 7060
Pfizer Investigational Site
Tongeren, 3700
Pfizer Investigational Site
Torhout, 8820
Pfizer Investigational Site
Tournai, 7500
Pfizer Investigational Site
Turnhout, 2300
Pfizer Investigational Site
Verviers, 4800
Pfizer Investigational Site
Waregem, 8790
Pfizer Investigational Site
Wilrijk, 2610
Pfizer Investigational Site
Yvoir, 5530
About this study
Official title: A Phase 4, Open-Label Exemestane Adjuvant Safety Surveillance Program: Adjuvant Exemestane (Aromasin) Treatment Following Previous Treatment With Tamoxifen in Postmenopausal Women With Estrogen Sensitive Primary Breast Cancer (IES Inclusion Criteria)
The purpose of this study was to give access to postmenopausal women with estrogen sensitive primary breast cancer to exemestane for the adjuvant treatment of breast cancer after the use of tamoxifen and to collect all serious adverse events.
- Conditions
- Breast Neoplasms
- Being tested
- 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.
exemestaneDrug
Exemestane 25 mg oral tablet once daily for a maximum of 3 years
| Study group | Role | What they receive |
|---|---|---|
| Exemestane group | Active comparator | Not described Receives: Drug: exemestane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess for serious adverse events
Measured: Months 3, 6, 12, 18, 24, and 30; Follow-up visit 28 days posttreatment
Secondary outcomes (1)
Safety Surveillance Program
Measured: Duration of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startMar 2005
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,549 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00649090
- Sponsor's protocol ID
- A5991077
- Status last verified
- Sep 2008
- First submitted
- 27 Mar 2008
- Last updated
- 29 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Open-Label Exemestane Adjuvant Safety Surveillance Program: Adjuvant Exemestane (Aromasin) Treatment Following Previous Treatment With Tamoxifen in Postmenopausal Women With Estrogen Sensitive Primary Breast Cancer (IES Inclusion Criteria)
- ClinicalTrials.gov ID
- NCT00649090
- Acronym / sponsor ID
- A5991077
- Conditions
- Breast Neoplasms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,549 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 1 Apr 2008 (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.
The purpose of this study was to give access to postmenopausal women with estrogen sensitive primary breast cancer to exemestane for the adjuvant treatment of breast cancer after the use of tamoxifen and to collect all serious adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exemestane group | Active comparator | Drug: exemestane |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Postmenopausal patients
- Patients with early breast cancer after adequate loco-regional treatment and eventual adjuvant chemotherapy, treated with tamoxifen for 2-3 years OR treated with tamoxifen for 2-3 years and consecutive exemestane treatment, provided the total duration of endocrine treatment is less than 5 years
- Estrogen receptor positive breast cancer patients
- Patients who remain free from disease following treatment with tamoxifen
Key exclusion criteria (3 listed)
- Patients taking other drugs for the adjuvant treatment of breast cancer
- Patients taking hormone replacement therapy
- Donation of blood or blood products for transfusion during the 30 days prior to initiation of treatment with study drug, at any time during the program or 30 days after completion of treatment
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 |
|---|---|---|
| exemestaneExemestane 25 mg oral tablet once daily for a maximum of 3 years | Drug | Exemestane group |
Primary outcome
Assess for serious adverse events
Time frame: Months 3, 6, 12, 18, 24, and 30; Follow-up visit 28 days posttreatment
1 secondary outcome
Safety Surveillance Program
Time frame: Duration of trial
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 Sep 2008.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
61 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing exemestane in people with Breast Neoplasms, run by Pfizer at 61 sites in Belgium.
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 4 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 29 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in Belgium. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Assess for serious adverse events (time frame: Months 3, 6, 12, 18, 24, and 30; Follow-up visit 28 days posttreatment). 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 Sep 2008.