Breast CancerAPOLLONCT00523315
APOLLO(Aromatase Inhibitor Patient cOmpLiance Program With qoL Questionaire)
An observational study of Breast Cancer, run by AstraZeneca at 19 sites in South Korea.
Trial summary
To describe patients' compliance of taking Aromatase Inhibitor as an adjuvant treatment in the postmenopausal, early breast cancer as seen under current practice Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 862 participants
- Where
- 19 sitesSouth Korea
- Study dates
- May 2007to Apr 2011
- Phase
- Observational
- 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
Study population: Department of Surgery or Department of Hemato-oncology in 36 hospitals
Who may be able to join
- Provision of written informed consent
- Patients with early breast cancer who are scheduled to receive first-line adjuvant endocrine therapy with aromatase inhibitor under the routine clinical practice
- Histologically or cytologically proven to be HR+(ER or PR +)
- Postmenopausal woman, defined as a woman fulfilling any of the following criteria(by the local guideline):
- Age >= 50 years
- Age < 50 years with amenorrhoea > 12 months and an intact uterus
Show all 9Show fewer
- FSH levels within postmenopausal range (over 30-40 IU/ml), or
- Having undergone a bilateral oophorectomy.
- No other concomitant endocrine therapy such as estrogen therapy or selective estrogen receptor modulators
Who cannot join
- Recurrence of breast cancer
- Known hypersensitivity to aromatase inhibitor or to any of the excipients
- Any severe concomitant condition which makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the trial protocol
- Previous inclusion in the present study
- Participation in a clinical study during the last 30 days
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
South Korea19 sites
Research Site
Anyang-si, Gyunggi-do
Research Site
Bucheon-si, Gyeonggi-do
Research Site
Busan
Research Site
Cheonan-si, Chuncheongnam-do
Research Site
Daegu
Research Site
Daejeon
Research Site
Daejoen
Reserach Site
Euijungbu-si, Gyunggi-do
Research Site
Goyang-si, Gyeonggi-do
Research Site
Gwangju
Research Site
Iksan-si, Jeollabuk-do
Research Site
Incheon
Research Site
Jeonju, Jeollabuk-do
Research Site
Jinju, Gyeongsangnam-do
Research Site
Kangnung-si, Gangwon-do
Research Site
Seongnam, Gyunggi-do
Research Site
Seoul
Research Site
Suwon, Gyunggi-do
Research Site
Ulsan
About this study
Official title: A Prospective Observational Study of Compliance in the Patients Receiving Aromatase Inhibitor as an Adjuvant Therapy in Postmenopausal Early Breast Cancer
To describe patients' compliance of taking Aromatase Inhibitor as an adjuvant treatment in the postmenopausal, early breast cancer as seen under current practice
- Conditions
- Breast Cancer
- Keywords
- Aromatase Inhibitor, Breast Cancer, compliance, Naturalistic, Observational
- Medical subject headings
- Breast Neoplasms, Patient Compliance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2007 (estimated)
- Study startMay 2007
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 862 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joon Woo Bahn, Study director, AstraZeneca Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523315
- Sponsor's protocol ID
- NIS-OKR-ARI-2007/1
- Acronym
- APOLLO
- Status last verified
- May 2011
- First submitted
- 30 Aug 2007
- Last updated
- 20 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Compliance in the Patients Receiving Aromatase Inhibitor as an Adjuvant Therapy in Postmenopausal Early Breast Cancer
- ClinicalTrials.gov ID
- NCT00523315
- Acronym / sponsor ID
- APOLLO / NIS-OKR-ARI-2007/1
- Conditions
- Breast Cancer
- Keywords
- Aromatase Inhibitor, Breast Cancer, compliance, Naturalistic, Observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 862 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 31 Aug 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 describe patients' compliance of taking Aromatase Inhibitor as an adjuvant treatment in the postmenopausal, early breast cancer as seen under current practice
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Department of Surgery or Department of Hemato-oncology in 36 hospitals
Key inclusion criteria (9 listed)
- Provision of written informed consent
- Patients with early breast cancer who are scheduled to receive first-line adjuvant endocrine therapy with aromatase inhibitor under the routine clinical practice
- Histologically or cytologically proven to be HR+(ER or PR +)
- Postmenopausal woman, defined as a woman fulfilling any of the following criteria(by the local guideline):
Key exclusion criteria (5 listed)
- Recurrence of breast cancer
- Known hypersensitivity to aromatase inhibitor or to any of the excipients
- Any severe concomitant condition which makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the trial protocol
- Previous inclusion in the present study
- Participation in a clinical study during the last 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 20 May 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.
Joon Woo Bahn study director
AstraZeneca Korea
19 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 AstraZeneca at 19 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 9 inclusion and 5 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 20 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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?
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.
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 20 May 2011.