Breast CancerNCT00623519
Assessment of Endometrial Changes in Postmenopausal Women With Breast Cancer in Adjuvant Treatment With Anastrozole
An observational study of Breast Cancer, run by AstraZeneca at 12 sites in Spain.
Trial summary
To investigate the global incidence of the endometrial changes in postmenopausal women receiving Anastrozole for the adjuvant treatment of hormone receptors positive breast cancer. 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
- 165 participants
- Where
- 12 sitesSpain
- Study dates
- Jun 2004to Feb 2009
- 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: Medical Oncology
Who may be able to join
- Provision of Informed Consent
- Resectable breast cancer patients, with histological confirmation
- Patients eligible to receive hormonal adjuvant treatment with Anastrozole
- They are allowed patients treated with adjuvant chemo or radiotherapy concurrently
- Patients previously treated with Tamoxifen that had to withdraw treatment due to other reason than endometrial changes are allowed
- Postmenopausal patients(aged 50 years or over/ without menses in the last months/ FSH level >40UI/L / women under 50 years with FSH levels>40UI/L).
- Women showing progesterone and/or estrogen receptors positive.
Who cannot join
- Patients with evidence of metastatic disease
- Patients unsuitable to receive the medication according the Anastrozole label
- Patients not giving their Informed Consent
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Spain12 sites
Research Site
A Coruña
Research Site
Granada
Research Site
Huelva
Research Site
Ibiza Town
Research Site
Jerez de la Frontera
Research Site
La Rioja
Research Site
Lugo
Research Site
Málaga
Research Site
Mallorca
Research Site
Pontevedra
Research Site
Santander
Research Site
Seville
About this study
Official title: Assessment of Endometrial Changes in Postmenopausal Women With Breast Cancer in Adjuvant Treatment With Anastrozole.
To investigate the global incidence of the endometrial changes in postmenopausal women receiving Anastrozole for the adjuvant treatment of hormone receptors positive breast cancer.
- Conditions
- Breast Cancer
- Keywords
- Adjuvant postmenopausal breast cancer women
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Women with hormone receptor positive breast cancer under adjuvant treatment with Anastrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global incidence of endometrial changes during the adjuvant treatment with Anastrozole
Measured: From inclusion to treatment end(5 years duration) measurements will be taken annually, with a further assessment 12 months after end of treatment.
Secondary outcomes (5)
To describe the endometrial changes both clinically(vaginal bleeding) and through the scan.
Measured: During the study, at least annually
Histological assessment when indicated(type of hyperplasia)
Measured: When applicable
To assess global incidence of endometrial changes in this patient population before taking Anastrozole
Measured: During the study
To evaluate type of surgery required for endometrial changes control(hysterectomy rate)
Measured: During the study
To assess treatment tolerability
Measured: During the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2008 (estimated)
- Study startJun 2004
- Study completionFeb 2009
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
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Rosana Cajal, MD, Study director, AstraZeneca Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623519
- Sponsor's protocol ID
- AST-ANA-2004-01
- Status last verified
- Mar 2009
- First submitted
- 6 Feb 2008
- Last updated
- 9 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Endometrial Changes in Postmenopausal Women With Breast Cancer in Adjuvant Treatment With Anastrozole.
- ClinicalTrials.gov ID
- NCT00623519
- Acronym / sponsor ID
- AST-ANA-2004-01
- Conditions
- Breast Cancer
- Keywords
- Adjuvant postmenopausal breast cancer women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Study completion
- Feb 2009 (actual)
- First posted
- 26 Feb 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.
To investigate the global incidence of the endometrial changes in postmenopausal women receiving Anastrozole for the adjuvant treatment of hormone receptors positive breast cancer.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Women with hormone receptor positive breast cancer under adjuvant treatment with Anastrozole |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Medical Oncology
Key inclusion criteria (7 listed)
- Provision of Informed Consent
- Resectable breast cancer patients, with histological confirmation
- Patients eligible to receive hormonal adjuvant treatment with Anastrozole
- They are allowed patients treated with adjuvant chemo or radiotherapy concurrently
- Patients previously treated with Tamoxifen that had to withdraw treatment due to other reason than endometrial changes are allowed
Key exclusion criteria (3 listed)
- Patients with evidence of metastatic disease
- Patients unsuitable to receive the medication according the Anastrozole label
- Patients not giving their Informed Consent
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
Global incidence of endometrial changes during the adjuvant treatment with Anastrozole
Time frame: From inclusion to treatment end(5 years duration) measurements will be taken annually, with a further assessment 12 months after end of treatment.
5 secondary outcomes
To describe the endometrial changes both clinically(vaginal bleeding) and through the scan.
Time frame: During the study, at least annually
Histological assessment when indicated(type of hyperplasia)
Time frame: When applicable
To assess global incidence of endometrial changes in this patient population before taking Anastrozole
Time frame: During the study
To evaluate type of surgery required for endometrial changes control(hysterectomy rate)
Time frame: During the study
To assess treatment tolerability
Time frame: During the study
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 9 Mar 2009.
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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.
Rosana Cajal, MD study director
AstraZeneca Spain
12 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 12 sites in Spain.
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 7 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 9 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain. 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?
Global incidence of endometrial changes during the adjuvant treatment with Anastrozole (time frame: From inclusion to treatment end(5 years duration) measurements will be taken annually, with a further assessment 12 months after end of treatment.). 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 9 Mar 2009; AzTrials last refreshed its copy on 8 Nov 2026.