Faslodex Observations During Regular Use by Advanced Mammacarcinoma Patients

An observational study of Breast Cancer, run by AstraZeneca at 43 sites in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The purpose of this study is to identify which patients, receiving Faslodex within the approved label, benefit most from Faslodex treatment. 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: 150 participants
Where: 43 sitesNetherlands
Study dates: Jun 2005to Dec 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

Who may be able to join

Postmenopausal
Locally advanced or metastatic hormone sensitive breast cancer with known estrogen receptor (ER) and progesterone receptor (PR) status
Patient had a recurrence during or after adjuvant anti-oestrogen treatment or progression of the disease during anti-oestrogen treatment

Who cannot join

Life threatening metastases

Trial locations and contacts

43 sites in 1 country.

City, postcode or hospital

43 sites in 1 country

Netherlands43 sites

Research Site
Alkmaar
Research Site
Almelo
Research Site
Almere Stad
Research Site
Amsterdam
Research Site
Apeldoorn
Research Site
Assen
Research Site
Bergen op Zoom
Research Site
Capelle aan den IJssel
Research Site
Delft
Research Site
Delfzijl
Research Site
Doetinchem
Research Site
Dokkum
Research Site
Dordrecht
Research Site
Drachten
Research Site
Ede Gld
Research Site
Eindhoven
Research Site
Geldrop
Research Site
Gorinchem
Research Site
Hardenberg
Research Site
Heerenveen
Research Site
Heerlen
Research Site
Hellevoetsluis
Research Site
Hilversum
Research Site
Hoogeveen
Research Site
Leiden
Research Site
Leiderdorp
Research Site
Leidschendam
Research Site
Meppel
Research Site
Nieuwegein
Research Site
Oss
Research Site
Roermond
Research Site
Rotterdam
Research Site
Stadskanaal
Research Site
Terneuzen
Research Site
The Hague
Research Site
Tilburg
Research Site
Utrecht
Research Site
Vlaardingen
Research Site
Winschoten
Research Site
Winterswijk
Research Site
Zeist
Research Site
Zevenaar
Research Site
Zwolle

Other trials in Netherlands

About this study

The purpose of this study is to identify which patients, receiving Faslodex within the approved label, benefit most from Faslodex treatment.

Conditions: Breast Cancer
Keywords: Advanced Breast Cancer
Medical subject headings: Breast Neoplasms

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2005Dec 2009

First posted19 Oct 2005 (estimated)
Study startJun 2005
Study completionDec 2009 (estimated)

Why it stopped: Due to poor patient enrollment

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: Case only
Time perspective: Prospective
Enrolment: 150 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00241462
Sponsor's protocol ID: D6997-NL-001
Other IDs: FORUM
Acronym: FORUM
Status last verified: Apr 2009
First submitted: 18 Oct 2005
Last updated: 22 Apr 2009
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Faslodex Observations During Regular Use by Advanced Mammacarcinoma Patients
ClinicalTrials.gov ID: NCT00241462
Acronym / sponsor ID: FORUM / D6997-NL-001
Conditions: Breast Cancer
Keywords: Advanced Breast Cancer
Study type: Observational
Recruitment status: TerminatedReason stopped: Due to poor patient enrollment
Enrolment: 150 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jun 2005
Study completion: Dec 2009 (estimated)
First posted: 19 Oct 2005 (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 identify which patients, receiving Faslodex within the approved label, benefit most from Faslodex treatment.

Study design

Observational model: Case only
Time perspective: Prospective

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)

Postmenopausal
Locally advanced or metastatic hormone sensitive breast cancer with known estrogen receptor (ER) and progesterone receptor (PR) status
Patient had a recurrence during or after adjuvant anti-oestrogen treatment or progression of the disease during anti-oestrogen treatment

Key exclusion criteria (1 listed)

Life threatening metastases

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 was stopped early (reason given: Due to poor patient enrollment). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2009.

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

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 Netherlands Medical Director, MD study director

AstraZeneca

43 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 43 sites in Netherlands.

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 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: stopped early, as of the sponsor's last update on 22 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in Netherlands. 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 was stopped early (reason given: Due to poor patient enrollment). Results are not available in the source record.

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?

On the ClinicalTrials.gov record for NCT00241462.

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 Apr 2009; AzTrials last refreshed its copy on 7 Nov 2026.