PostmenopauseACT-FASTER:NCT01171417
A Treatment With Fulvestrant and Exemestane in Postmenopausal Patients With Advanced Hormone Receptor-Positive (HR) + Breast Cancer
An observational study of Postmenopause and Breast Cancer, run by AstraZeneca at 92 sites in Germany.
Trial summary
For patients receiving Faslodex 500 mg, to compare the effectiveness in terms of Time to Progression (TTP) as a function of the line of treatment (i.e. 1st vs. 2nd vs. 3rd line). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postmenopause, Breast Cancer
- How many people
- 570 participants
- Where
- 92 sitesGermany
- Study dates
- Aug 2010to Nov 2013
- 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: 660 patients in 140 sites in Germany. 100 specialists and 40 hospitals. Each site should enrol 4-20 patients
Who may be able to join
- Signed written informed consent
- Female postmenopausal patient (or patient post-ovariectomy) and age ≥18 years Postmenopause ist defined as
- Age ≥ 60 years and natural menopause with menses > 1year ago or
- FSH and E2 levels in the postmenopausal range or
- Patients who had bilateral ovariectomy (NCCN V.I. 2009)
- Histologically confirmed ER+ locally advanced or metastatic breast cancer
Show all 10Show fewer
- Not eligible for curative therapy
- Prior treatment with tamoxifen
- Suitable to undergo endocrine treatment for ER+ ABC with SERD / sAI
- Patient is able to read and understand German
Who cannot join
- Known hypersensitivity to Faslodex or Exemestane or any compounds of the drugs
- Prior treatment with Faslodex 500 mg or Faslodex 250 mg*
- for patients who receive treatment with Faslodex 500 mg within this observational study. Patients who are included in the exemestane arm may have received prior Faslodex treatment.
- Prior treatment with Exemestane for patients who receive treatment with Exemestane within this observational study
- Acutely life threatening disease
- Treatment with Faslodex 250 mg/month (previously approved dose)
- Prior palliative chemotherapy
Trial locations and contacts
92 sites in 1 country.
92 sites in 1 country
Germany92 sites
Research Site
Aachen
Research Site
Ahaus
Research Site
Amberg
Research Site
Aschaffenburg
Research Site
Aschersleben
Research Site
Bad Nauheim
Research Site
Bad Segeberg
Research Site
Bamberg
Research Site
Bergisch Gladbach
Research Site
Berlin
Research Site
Bielefeld
Research Site
Böblingen
Research Site
Bonn
Research Site
Braunschweig
Research Site
Castrop-Rauxel
Research Site
Chemnitz
Research Site
Cologne
Research Site
Dachau
Research Site
Donauwurth
Research Site
Dortmund
Research Site
Dresden
Research Site
Düsseldorf
Research Site
Eggenfelden
Research Site
Erfurt
Research Site
Eschweiler
Research Site
Essen
Research Site
Esslingen am Neckar
Research Site
Euskirchen
Research Site
Frankfurt
Research Site
Frechen
Research Site
Freiburg im Breisgau
Research Site
Fürstenwalde
Research Site
Geesthacht
Research Site
Gera
Research Site
Goslar
Research Site
Göttingen
Research Site
Gröbenzell
Research Site
Hamburg
Research Site
Hanau
Research Site
Hanover
Research Site
Heidelberg
Research Site
Heidenheim
Research Site
Herdecke
Research Site
Hof
Research Site
Ilsede
Research Site
Ingolstadt
Research Site
Karlsruhe
Research Site
Kassel
Research Site
Kiel
Research Site
Landshut
Research Site
Langen
Research Site
Lehrte
Research Site
Lübeck
Research Site
Ludwigsburg
Research Site
Magdeburg
Research Site
Mayen
Research Site
Memmingen
Research Site
Mittweida
Research Site
Moers
Research Site
Mönchengladbach
Research Site
Mühlhausen
Research Site
München
Research Site
Münster
Research Site
Naunhof
Research Site
Nordhausen
Research Site
Nordhorn
Research Site
Nuremberg
Research Site
Oberhausen
Research Site
Offenbach
Research Site
Osnabrück
Research Site
Passau
Research Site
Plüderhausen
Research Site
Remagen
Research Site
Remscheid
Research Site
Rendsburg
Research Site
Rodewisch
Research Site
Rodgau
Research Site
Simmern
Research Site
Soest
Research Site
Stendal
Research Site
Stralsund
Research Site
Stuttgart
Research Site
Troisdorf
Research Site
Tübingen
Research Site
Villingen-Schwenningen
Research Site
Weiden
Research Site
Wetzlar
Research Site
Wiesbaden
Research Site
Worms
Research Site
Würselen
Research Site
Würzburg
Research Site
Zittau
About this study
Official title: An Epidemiological Prospective Cohort Study to Describe Treatment Patterns of Fulvestrant And ExemeSTane in Postmenopausal Patients With Advanced HR+ Breast Cancer Under Real-life Conditions in GERmany
For patients receiving Faslodex 500 mg, to compare the effectiveness in terms of Time to Progression (TTP) as a function of the line of treatment (i.e. 1st vs. 2nd vs. 3rd line). For all patients, to collect and explore real-life data on the epidemiology and management of Pseudomyxoma Peritonea (PMP) patients with HR+ advanced breast cancer (ABC) treated with Faslodex 500 mg or exemestane.
- Conditions
- Postmenopause, Breast Cancer
- Keywords
- Fulvestrant, Exemestane, postmenopausal patients, advanced HR+ breast cancer, Hormone Receptor positive, advanced breast cancer
- 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 |
|---|---|---|
| Cohort 1 | 1st-line Faslodex 500 mg | |
| Cohort 2 | 2nd-line Faslodex 500 mg | |
| Cohort 3 | 3rd- line Faslodex 500 mg | |
| Cohort 4 | patients on exemestane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the effectiveness of Faslodex 500 mg in terms of time to progression (TTP) of disease.
Measured: Period from inclusion up to 9 months (average time period )
Disease management data
The analysis will be adjusted for the main prognostic factors, such as visceral metastases, age, receptor status etc
Measured: Period from inclusion up to 9 months (average time period )
Secondary outcomes (3)
Real-life data on patient outcomes by line of treatment (i.e. 1st vs. 2nd vs. 3rd line).
Including overall survival (OS), progression-free survival (PFS),time to progression (TTP), response rate (RR) and clinical benefit rate (CBR)
Measured: Every 3 months
Real-life pharmacoeconomic data and use of health care resources.
According to lines of treatment and other patient related factors (such as age, co-morbidities etc.), including primary care visits, hospital stays and other resource
Measured: Every 3 months
Health-related quality of life (HRQoL) in patients undergoing treatment with Faslodex 500 mg or exemestane.
Health-related quality of life will be assessed with a patient-based instrument (eg, EQ5D).
Measured: Every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostmenopauseStudies 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
- 570 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicolai Maass, Prof. Dr. med., Principal investigator, 52074 Aachen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171417
- Sponsor's protocol ID
- NIS-ODE-FAS-2009/1
- Other IDs
- NIS-ODE-FAS-2009/1
- Acronym
- ACT-FASTER:
- Status last verified
- Feb 2014
- First submitted
- 23 Jun 2010
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Epidemiological Prospective Cohort Study to Describe Treatment Patterns of Fulvestrant And ExemeSTane in Postmenopausal Patients With Advanced HR+ Breast Cancer Under Real-life Conditions in GERmany
- ClinicalTrials.gov ID
- NCT01171417
- Acronym / sponsor ID
- ACT-FASTER: / NIS-ODE-FAS-2009/1
- Conditions
- Postmenopause, Breast Cancer
- Keywords
- Fulvestrant, Exemestane, postmenopausal patients, advanced HR+ breast cancer, Hormone Receptor positive, advanced breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 570 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 28 Jul 2010 (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.
For patients receiving Faslodex 500 mg, to compare the effectiveness in terms of Time to Progression (TTP) as a function of the line of treatment (i.e. 1st vs. 2nd vs. 3rd line). For all patients, to collect and explore real-life data on the epidemiology and management of Pseudomyxoma Peritonea (PMP) patients with HR+ advanced breast cancer (ABC) treated with Faslodex 500 mg or exemestane.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –1st-line Faslodex 500 mg |
| Cohort 2 | – | –2nd-line Faslodex 500 mg |
| Cohort 3 | – | –3rd- line Faslodex 500 mg |
| Cohort 4 | – | –patients on exemestane |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 660 patients in 140 sites in Germany. 100 specialists and 40 hospitals. Each site should enrol 4-20 patients
Key inclusion criteria (10 listed)
- Signed written informed consent
- Female postmenopausal patient (or patient post-ovariectomy) and age ≥18 years Postmenopause ist defined as
- Histologically confirmed ER+ locally advanced or metastatic breast cancer
- Not eligible for curative therapy
- Prior treatment with tamoxifen
Key exclusion criteria (7 listed)
- Known hypersensitivity to Faslodex or Exemestane or any compounds of the drugs
- Prior treatment with Faslodex 500 mg or Faslodex 250 mg*
- Prior treatment with Exemestane for patients who receive treatment with Exemestane within this observational study
- Acutely life threatening disease
- Treatment with Faslodex 250 mg/month (previously approved dose)
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
Evaluation of the effectiveness of Faslodex 500 mg in terms of time to progression (TTP) of disease.
Time frame: Period from inclusion up to 9 months (average time period )
Disease management data
Time frame: Period from inclusion up to 9 months (average time period )
The analysis will be adjusted for the main prognostic factors, such as visceral metastases, age, receptor status etc
3 secondary outcomes
Real-life data on patient outcomes by line of treatment (i.e. 1st vs. 2nd vs. 3rd line).
Time frame: Every 3 months
Real-life pharmacoeconomic data and use of health care resources.
Time frame: Every 3 months
Health-related quality of life (HRQoL) in patients undergoing treatment with Faslodex 500 mg or exemestane.
Time frame: Every 3 months
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 27 Feb 2014.
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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.
Nicolai Maass, Prof. Dr. med. principal investigator
52074 Aachen, Germany
92 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postmenopause and Breast Cancer, run by AstraZeneca at 92 sites in Germany.
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 10 inclusion and 7 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 27 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 92 sites in Germany. 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?
Evaluation of the effectiveness of Faslodex 500 mg in terms of time to progression (TTP) of disease. (time frame: Period from inclusion up to 9 months (average time period )). The study lists 2 primary outcomes in all. 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 27 Feb 2014.