Early Breast CancerPhase 4NCT00323479
Arthralgia During Anastrozole Therapy for Breast Cancer
A Phase 4 study testing Anastrozole in people with Early Breast Cancer, run by AstraZeneca at 5 sites in France.
Trial summary
The purpose of this study is to describe the joint symptoms and structural joint changes under anastrozole as adjuvant treatment in postmenopausal women with early breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early Breast Cancer
- What is being tested?
- Anastrozole
- Type of treatment
- Pill or oral medicine
- How many people
- 114 participants
- Where
- 5 sitesFrance
- Study dates
- Jun 2006to Jan 2009
- Phase
- Phase 4
- 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
Who may be able to join
- Post menopausal woman with a breast cancer and scheduled for an adjuvant treatment with anastrozole
- WHO performance status 0, 1 or 2
- Provision of written informed consent
Who cannot join
- Recurrence of breast cancer, inflammatory rheumatism
- treatment by chondromodulator, oral glucocorticoid, aromatase inhibitor, anti estrogen, Herceptin
- Diabetes treated by insulin
- Severe renal or hepatic disease
- Known hypersensitivity to anastrozole
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Research Site
Bordeaux
Research Site
Caen
Research Site
Lyon
Research Site
Paris
Research Site
Poitiers
About this study
Official title: A Multicentre, Open Study Assessing Joint Disorders Under ARIMIDEX® (1mg/Day) as Adjuvant Treatment in Post Menopausal Women With Early Breast Cancer
The purpose of this study is to describe the joint symptoms and structural joint changes under anastrozole as adjuvant treatment in postmenopausal women with early breast cancer.
- Conditions
- Early Breast Cancer
- Being tested
- Anastrozole
- Keywords
- breast cancer treatment, joint disorders
- Medical subject headings
- Breast Neoplasms, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnastrozoleDrug
Also called ARIMIDEX, ZD1033
1mg/Day oral
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With New Events of Arthralgia
Measured: 12 months
Secondary outcomes (5)
Functional Index of Cochin at 12 Months in Patients Under Anastrozole.
Functional index of cochin score (from 0 to 90) : sum up of 18 questions on activities involving hands (each question scored from 0 = yes without difficulties (best) to 5 = impossible (worst)) based on 99 patients due to missing values.
Measured: 12 months
Serum Collagen Degradation Type I - CTX-I at 12 Months in Patients Under Anastrozole
Results are based on 97 patients due to missing values
Measured: 12 months
Kellgren and Lawrence Score at 12 Months in Patients Under Anastrozole
X ray evaluation of arthritis in 30 articulations ; each articulation scored from (0 = no arthritis to 4 = severe arthritis) based on 92 patients due to missing values
Measured: 12 months
Synovial Membrane Thickness at 12 Months in Patients Under Anastrozole
X ray assessment on hands and wrists based on 99 patients due to missing values
Measured: 12 months
Percentage of Participant With Therapeutic Maintenance Under Anastrozole
Treatment compliance. results based on 109 patients due to missing values
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2006 (estimated)
- Study startJun 2006
- Primary completionJan 2009
- Study completionJan 2009
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 Early 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AstraZeneca France Medical Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00323479
- Sponsor's protocol ID
- D5392L00013
- Other IDs
- 2005-00-5441-19 EUDRACT number
- Status last verified
- Mar 2012
- First submitted
- 8 May 2006
- Last updated
- 6 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open Study Assessing Joint Disorders Under ARIMIDEX® (1mg/Day) as Adjuvant Treatment in Post Menopausal Women With Early Breast Cancer
- ClinicalTrials.gov ID
- NCT00323479
- Acronym / sponsor ID
- D5392L00013
- Conditions
- Early Breast Cancer
- Keywords
- breast cancer treatment, joint disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 9 May 2006 (estimated)
- Results
- Posted 6 Apr 2012
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 the joint symptoms and structural joint changes under anastrozole as adjuvant treatment in postmenopausal women with early breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Post menopausal woman with a breast cancer and scheduled for an adjuvant treatment with anastrozole
- WHO performance status 0, 1 or 2
- Provision of written informed consent
Key exclusion criteria (5 listed)
- Recurrence of breast cancer, inflammatory rheumatism
- treatment by chondromodulator, oral glucocorticoid, aromatase inhibitor, anti estrogen, Herceptin
- Diabetes treated by insulin
- Severe renal or hepatic disease
- Known hypersensitivity to anastrozole
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 |
|---|---|---|
| AnastrozoleAlso: ARIMIDEX, ZD10331mg/Day oral | Drug | – |
Primary outcome
Number of Participants With New Events of Arthralgia
Time frame: 12 months
5 secondary outcomes
Functional Index of Cochin at 12 Months in Patients Under Anastrozole.
Time frame: 12 months
Serum Collagen Degradation Type I - CTX-I at 12 Months in Patients Under Anastrozole
Time frame: 12 months
Kellgren and Lawrence Score at 12 Months in Patients Under Anastrozole
Time frame: 12 months
Synovial Membrane Thickness at 12 Months in Patients Under Anastrozole
Time frame: 12 months
Percentage of Participant With Therapeutic Maintenance Under Anastrozole
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
AstraZeneca France Medical Director, MD study director
AstraZeneca
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anastrozole in people with Early Breast Cancer, run by AstraZeneca 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 3 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 6 Apr 2012. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2012). 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?
Number of Participants With New Events of Arthralgia (time frame: 12 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 6 Apr 2012.