Breast CancerNCT00737009
An Observational Study of Adherence to Anastrozole in Early Breast Cancer Treatment
An observational study of Breast Cancer, run by AstraZeneca at 3 sites in Vietnam.
Trial summary
The purpose of this study is to describe adherence to anastrozole treatment current practice: cases where anastrozole treatment was halted ( timescale and causes) and estimate the proportion of postmenopausal women with early breast cancer who continue anastrozole therapy after one year follow-up. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 259 participants
- Where
- 3 sitesVietnam
- Study dates
- Aug 2008to Mar 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The target study population comprised of postmenopausal women with early breast cancer who were treated with anastrozole for at least one month and are willing to give written informed consent to participate.
Who may be able to join
- Postmenopausal woman with early breast cancer who are prescribed with anastrozole as adjuvant endocrine therapy under the routine clinical practice.
- Histologically or cytologically proven to be HR+(ER or PR +)
- No other concomitant endocrine therapy such as estrogen therapy or selective estrogen receptor modulators
- Provision of written informed consent
Who cannot join
- Recurrence of breast cancer
- Known hypersensitivity to anastrozole or to any of its excipients
- Any severe concomitant condition which makes it undesirable for the patient to participate in the trial or which would jeopardize adherence with the trial protocol: Amenorrhea<12 months and a intact uterus; Previous inclusion in the present study; Participation in a other clinical study during the last 30 days·
- Women who does not agreed to participate the program
Trial locations and contacts
3 sites in 1 country.
Vietnam3 sites
Research Site
Hanoi
Research Site
Ho Chi Minh City
Research Site
Huế
About this study
Official title: An Observational Study of Adherence to Adjuvant Anastrozole Therapy in Postmenopausal Patients With Early Breast Cancer Over One Year Follow-up.
The purpose of this study is to describe adherence to anastrozole treatment current practice: cases where anastrozole treatment was halted ( timescale and causes) and estimate the proportion of postmenopausal women with early breast cancer who continue anastrozole therapy after one year follow-up.
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, adherence, anastrozole, post-menopausal women
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe adherence to anastrozole treatment current practice: cases where anastrozole treatment was halted ( timescale and causes)
Measured: every 3- 6 months (4 visit in one year)
Secondary outcomes (4)
Estimate the proportion of postmenopausal women with early breast cancer who continue anastrozole therapy after one year follow-up
Measured: every 3- 6 months (4 visit in one year)
Identify predictors of non- adherence
Measured: every 3- 6 months (4 visit in one year)
The proportion of DFS after 1 year follow-up
Measured: every 3- 6 months (4 visit in one year)
Describe menopausal symptoms
Measured: every 3- 6 months (4 visit in one year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionMar 2011
- Study completionMar 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
- Time perspective
- Prospective
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nguyen Van Dinh, MD, Principal investigator, K Hospital Hanoi, VietnamTran Nguyen Ha, Principal investigator, HCMC Cancer HospitalTran Dang Khoa, Principal investigator, Hanoi Cancer HospitalTon That Cau, Principal investigator, Hue Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737009
- Sponsor's protocol ID
- NIS-OVN-ARI-2008/1
- Status last verified
- Jun 2011
- First submitted
- 15 Aug 2008
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Adherence to Adjuvant Anastrozole Therapy in Postmenopausal Patients With Early Breast Cancer Over One Year Follow-up.
- ClinicalTrials.gov ID
- NCT00737009
- Acronym / sponsor ID
- NIS-OVN-ARI-2008/1
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, adherence, anastrozole, post-menopausal women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 18 Aug 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 is to describe adherence to anastrozole treatment current practice: cases where anastrozole treatment was halted ( timescale and causes) and estimate the proportion of postmenopausal women with early breast cancer who continue anastrozole therapy after one year follow-up.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The target study population comprised of postmenopausal women with early breast cancer who were treated with anastrozole for at least one month and are willing to give written informed consent to participate.
Key inclusion criteria (4 listed)
- Postmenopausal woman with early breast cancer who are prescribed with anastrozole as adjuvant endocrine therapy under the routine clinical practice.
- Histologically or cytologically proven to be HR+(ER or PR +)
- No other concomitant endocrine therapy such as estrogen therapy or selective estrogen receptor modulators
- Provision of written informed consent
Key exclusion criteria (4 listed)
- Recurrence of breast cancer
- Known hypersensitivity to anastrozole or to any of its excipients
- Any severe concomitant condition which makes it undesirable for the patient to participate in the trial or which would jeopardize adherence with the trial protocol: Amenorrhea<12 months and a intact uterus; Previous inclusion in the present study; Participation in a other clinical study during the last 30 days·
- Women who does not agreed to participate the program
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
To describe adherence to anastrozole treatment current practice: cases where anastrozole treatment was halted ( timescale and causes)
Time frame: every 3- 6 months (4 visit in one year)
4 secondary outcomes
Estimate the proportion of postmenopausal women with early breast cancer who continue anastrozole therapy after one year follow-up
Time frame: every 3- 6 months (4 visit in one year)
Identify predictors of non- adherence
Time frame: every 3- 6 months (4 visit in one year)
The proportion of DFS after 1 year follow-up
Time frame: every 3- 6 months (4 visit in one year)
Describe menopausal symptoms
Time frame: every 3- 6 months (4 visit in one year)
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 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.
Nguyen Van Dinh, MD principal investigator
K Hospital Hanoi, Vietnam
Tran Nguyen Ha principal investigator
HCMC Cancer Hospital
Tran Dang Khoa principal investigator
Hanoi Cancer Hospital
3 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 3 sites in Vietnam.
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 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 22 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Vietnam. 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.
What does the primary outcome measure?
To describe adherence to anastrozole treatment current practice: cases where anastrozole treatment was halted ( timescale and causes) (time frame: every 3- 6 months (4 visit in one year)). 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 Jun 2011.