Breast NeoplasmsPhase 2NCT00174343
Exemestane As Treatment In Neoadjuvant Setting For Operable Breast Cancer Patients
A Phase 2 study testing exemestane (Aromasin®) in people with Breast Neoplasms, run by Pfizer at 5 sites in France.
Trial summary
To evaluate clinical and pathologic response rates following primary hormonal therapy by exemestane (Aromasin®) 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 (Aromasin®)
- How many people
- 46 participants
- Where
- 5 sitesFrance
- Study dates
- Nov 2001to Sep 2006
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Post-menopausal patients with unilateral breast cancer T2 to T4, N0-1, M0, non inflammatory, operable, hormonal receptors positive
Who cannot join
- Patients with bilateral breast cancer T4d, inflammatory, non operable, hormonal receptors negative
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Pfizer Investigational Site
Bordeaux
Pfizer Investigational Site
Clermont-Ferrand
Pfizer Investigational Site
Montpellier
Pfizer Investigational Site
Poitiers
Pfizer Investigational Site
Saint-Cloud
About this study
Official title: Phase II Study Evaluating The Role Of Exemestane On Clinical And Pathologic Response Rates, And Its Aromatase Activity As Treatment In Neoadjuvant Setting For Operable Breast Cancer Patients.
To evaluate clinical and pathologic response rates following primary hormonal therapy by exemestane (Aromasin®)
- Conditions
- Breast Neoplasms
- Being tested
- exemestane (Aromasin®)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exemestane (Aromasin®)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate clinical and pathologic response rates following primary hormonal therapy by exemestane (Aromasin®)
Secondary outcomes (1)
To evaluate breast conservative surgery rate; To evaluate intratumoral anti-aromatase activity.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startNov 2001
- Study completionSep 2006
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants
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
- NCT00174343
- Sponsor's protocol ID
- 971-ONC-0028-095
- Status last verified
- Apr 2011
- First submitted
- 9 Sep 2005
- Last updated
- 22 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Evaluating The Role Of Exemestane On Clinical And Pathologic Response Rates, And Its Aromatase Activity As Treatment In Neoadjuvant Setting For Operable Breast Cancer Patients.
- ClinicalTrials.gov ID
- NCT00174343
- Acronym / sponsor ID
- 971-ONC-0028-095
- Conditions
- Breast Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2001
- Study completion
- Sep 2006 (actual)
- First posted
- 15 Sep 2005 (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 evaluate clinical and pathologic response rates following primary hormonal therapy by exemestane (Aromasin®)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Post-menopausal patients with unilateral breast cancer T2 to T4, N0-1, M0, non inflammatory, operable, hormonal receptors positive
Key exclusion criteria (1 listed)
- Patients with bilateral breast cancer T4d, inflammatory, non operable, hormonal receptors negative
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 |
|---|---|---|
| exemestane (Aromasin®) | Drug | – |
Primary outcome
To evaluate clinical and pathologic response rates following primary hormonal therapy by exemestane (Aromasin®)
1 secondary outcome
To evaluate breast conservative surgery rate; To evaluate intratumoral anti-aromatase activity.
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 22 Apr 2011.
- 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
5 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 exemestane (Aromasin®) in people with Breast Neoplasms, run by Pfizer at 5 sites in France.
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 1 inclusion and 1 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 22 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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 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?
To evaluate clinical and pathologic response rates following primary hormonal therapy by exemestane (Aromasin®). 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 22 Apr 2011.