Breast CancerNCT01047358
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Aromasin In The Patients With Early Or Advanced Breast Cancer
An observational study of Breast Cancer, run by Pfizer at 22 sites in South Korea.
Trial summary
This non-interventional study is to monitor use in real practice in Korea including adverse events on Aromasin (Exemestane). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Aromasin
- How many people
- 206 participants
- Where
- 22 sitesSouth Korea
- Study dates
- Jun 2010to Jun 2014
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: - Postmenopausal women diagnosed as estrogen-receptor positive early breast cancer, who have received two to three years of tamoxifen and are switched to AROMASIN for completion of a total of five consecutive years of adjuvant hormonal therapy OR postmenopausal women with breast cancer that has progressed following anti-estrogen therapy.
Who may be able to join
- - Postmenopausal women with breast cancer eligible for hormonal therapy.
Who cannot join
- Pregnant breast-feeding premenopausal.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
South Korea22 sites
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, 431-070
Soon Chun Hyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, 420-767
Inje University Busan Paik Hospital
Busan, 614-735
Soon Chun Hyang University Hospital Cheonan
Cheonan, Chungcheongnam-do, 330-721
Hwasun Hospital, Chonnam National University
Cheonnam, South Jeolla Province, 519-809
Yeung Nam University Hospital
Daegu, 705-717
Myongji Hospital, Kwangdong Unversity College of Medicine
Goyang-si, Gyeonggi-do, 412-270
Seoul National University Bundang Hospital
Gyeonggi-do, 463-707
Wonkwang University School of Medicine and Hospital (WUH)
Iksan -si, Jeollabuk-do, 570-749
Inha University Hospital
Incheon, 400-711
Asan Medical Center
Seoul, Korea, 138-736
Seoul National University Hospital (SNUH)
Seoul, Seoul, 110-744
Cheil General Hospital & Women's Healthcare Center
Seoul, 100-380
Seoul National University Hospital
Seoul, 110-744
Severance Hospital, Yonsei University Health System, Yonsei Cancer Center
Seoul, 120-752
Samsung Medical Center
Seoul, 135 710
Korea University Anam Hospital
Seoul, 136-705
Asan Medical Center, University of Ulsan
Seoul, 138-736
Korea University Medical Center (KUMC) - Korea University Guro Hospital
Seoul, 152-703
SMG-SNU Boramae Medical Center
Seoul, 156-707
Ewha Womans University Mokdong Hospital
Seoul, 158-710
Ajou University Hospital
Suwon, 443-380
About this study
This non-interventional study is to monitor use in real practice in Korea including adverse events on Aromasin (Exemestane).
Read the detailed description
All cases at the participating institutions.
- Conditions
- Breast Cancer
- Being tested
- 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.
AromasinDrug
Also called exemestane
25 mg table QD
AromasinDrug
Also called exemestane
25 mg table QD
| Study group | Role | What they receive |
|---|---|---|
| ajuvant group | adjuvant setting after two to three years of tamoxifen Receives: Drug: Aromasin | |
| palliative group | palliative setting after progression of disease with anti-estrogen therapy Receives: Drug: Aromasin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
All AEs reported after start of administration of Aromasin were considered as TEAEs and summarized.
Measured: From the first dose of Aromasin through the end of the study for an average of 5.6 months
Secondary outcomes (3)
Percentage of Participants Without Recurrence/Metastasis (Early Breast Cancer)
The antitumor efficacy for early breast cancer was measured by recurrence/metastasis status (Yes or No) of the participant at the end of the study. The investigator recorded the final evaluation date and the information of tumor recurrence or metastasis (Yes or No) in each participant's case report form (CRF).
Measured: At the end of the study, average of 5.6 months.
Time-to-Progression (Early Breast Cancer)
Time-to-Progression was defined as the duration from the date of first administration of Aromasin to the date of recurrence or contralateral breast cancer.
Measured: At the end of the study, average of 5.6 months
Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer)
The antitumor efficacy for advanced breast cancer was measured by objective tumor assessments according to the RECIST of uni-dimensional evaluation. Complete response (CR) was defined as disappearance of all target and non-target lesions, and no new lesions. Partial response (PR) was defined as disappearance of all target lesions, a persistence of ≥1 non-target lesions, no new lesions; or a ≥30% decrease in the sum of the longest dimensions of the target lesions, no unequivocal progression of existing non-target lesions, no new lesions. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), no unequivocal progression of existing non-target lesions, and no new lesions. PD was defined as a ≥20% increase in the sum of the longest dimensions of the target lesions; or unequivocal progression of existing non-target lesions, or the appearance of ≥1 new lesions.
Measured: At the end of the study, average of 5.6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2014
- Study completionJun 2014
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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047358
- Sponsor's protocol ID
- A5991089
- Status last verified
- Oct 2015
- First submitted
- 24 Dec 2009
- Last updated
- 8 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance Study To Observe Safety And Efficacy Of Aromasin In The Patients With Early Or Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT01047358
- Acronym / sponsor ID
- A5991089
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 12 Jan 2010 (estimated)
- Results
- Posted 9 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This non-interventional study is to monitor use in real practice in Korea including adverse events on Aromasin (Exemestane).
Detailed description
All cases at the participating institutions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ajuvant group | – | Drug: Aromasinadjuvant setting after two to three years of tamoxifen |
| palliative group | – | Drug: Aromasinpalliative setting after progression of disease with anti-estrogen therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Postmenopausal women diagnosed as estrogen-receptor positive early breast cancer, who have received two to three years of tamoxifen and are switched to AROMASIN for completion of a total of five consecutive years of adjuvant hormonal therapy OR postmenopausal women with breast cancer that has progressed following anti-estrogen therapy.
Key inclusion criteria (1 listed)
- - Postmenopausal women with breast cancer eligible for hormonal therapy.
Key exclusion criteria (1 listed)
- Pregnant breast-feeding premenopausal.
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 |
|---|---|---|
| AromasinAlso: exemestane25 mg table QD | Drug | ajuvant group |
| AromasinAlso: exemestane25 mg table QD | Drug | palliative group |
Primary outcome
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From the first dose of Aromasin through the end of the study for an average of 5.6 months
All AEs reported after start of administration of Aromasin were considered as TEAEs and summarized.
3 secondary outcomes
Percentage of Participants Without Recurrence/Metastasis (Early Breast Cancer)
Time frame: At the end of the study, average of 5.6 months.
Time-to-Progression (Early Breast Cancer)
Time frame: At the end of the study, average of 5.6 months
Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer)
Time frame: At the end of the study, average of 5.6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Pfizer at 22 sites in South Korea.
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 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in South Korea. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2015). 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?
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: From the first dose of Aromasin through the end of the study for an average of 5.6 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 8 Oct 2015.