A Treatment With Fulvestrant and Exemestane in Postmenopausal Patients With Advanced Hormone Receptor-Positive (HR) + Breast Cancer (ACT-FASTER:)

February 26, 2014 updated by: AstraZeneca

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
570

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany
        • Research Site
      • Ahaus, Germany
        • Research Site
      • Amberg, Germany
        • Research Site
      • Aschaffenburg, Germany
        • Research Site
      • Aschersleben, Germany
        • Research Site
      • Bad Nauheim, Germany
        • Research Site
      • Bad Segeberg, Germany
        • Research Site
      • Bamberg, Germany
        • Research Site
      • Bergisch Gladbach, Germany
        • Research Site
      • Berlin, Germany
        • Research Site
      • Bielefeld, Germany
        • Research Site
      • Boblingen, Germany
        • Research Site
      • Bonn, Germany
        • Research Site
      • Braunschweig, Germany
        • Research Site
      • Castrop-Rauxel, Germany
        • Research Site
      • Chemnitz, Germany
        • Research Site
      • Dachau, Germany
        • Research Site
      • Donauwurth, Germany
        • Research Site
      • Dortmund, Germany
        • Research Site
      • Dresden, Germany
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      • Dusseldorf, Germany
        • Research Site
      • Eggenfelden, Germany
        • Research Site
      • Erfurt, Germany
        • Research Site
      • Eschweiler, Germany
        • Research Site
      • Essen, Germany
        • Research Site
      • Esslingen, Germany
        • Research Site
      • Euskirchen, Germany
        • Research Site
      • Frankfurt, Germany
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      • Frechen, Germany
        • Research Site
      • Freiburg, Germany
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      • Furstenwalde, Germany
        • Research Site
      • Geesthacht, Germany
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      • Gera, Germany
        • Research Site
      • Goslar, Germany
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      • Gottingen, Germany
        • Research Site
      • Grobenzell, Germany
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      • Hamburg, Germany
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      • Hanau, Germany
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      • Hannover, Germany
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      • Heidelberg, Germany
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      • Heidenheim, Germany
        • Research Site
      • Herdecke, Germany
        • Research Site
      • Hof, Germany
        • Research Site
      • Ilsede, Germany
        • Research Site
      • Ingolstadt, Germany
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      • Karlsruhe, Germany
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      • Kassel, Germany
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      • Kiel, Germany
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      • Koln, Germany
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      • Landshut, Germany
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      • Langen, Germany
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      • Lehrte, Germany
        • Research Site
      • Lubeck, Germany
        • Research Site
      • Ludwigsburg, Germany
        • Research Site
      • Magdeburg, Germany
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      • Mayen, Germany
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      • Memmingen, Germany
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      • Mittweida, Germany
        • Research Site
      • Moers, Germany
        • Research Site
      • Monchengladbach, Germany
        • Research Site
      • Muhlhausen, Germany
        • Research Site
      • Munchen, Germany
        • Research Site
      • Munster, Germany
        • Research Site
      • Naunhof, Germany
        • Research Site
      • Nordhausen, Germany
        • Research Site
      • Nordhorn, Germany
        • Research Site
      • Nurnberg, Germany
        • Research Site
      • Oberhausen, Germany
        • Research Site
      • Offenbach, Germany
        • Research Site
      • Osnabruck, Germany
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      • Passau, Germany
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      • Pluderhausen, Germany
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      • Remagen, Germany
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      • Remscheid, Germany
        • Research Site
      • Rendsburg, Germany
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      • Rodewisch, Germany
        • Research Site
      • Rodgau, Germany
        • Research Site
      • Simmern, Germany
        • Research Site
      • Soest, Germany
        • Research Site
      • Stendal, Germany
        • Research Site
      • Stralsund, Germany
        • Research Site
      • Stuttgart, Germany
        • Research Site
      • Troisdorf, Germany
        • Research Site
      • Tubingen, Germany
        • Research Site
      • Villingen-Schwenningen, Germany
        • Research Site
      • Weiden, Germany
        • Research Site
      • Wetzlar, Germany
        • Research Site
      • Wiesbaden, Germany
        • Research Site
      • Worms, Germany
        • Research Site
      • Wurselen, Germany
        • Research Site
      • Wurzburg, Germany
        • Research Site
      • Zittau, Germany
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

660 patients in 140 sites in Germany. 100 specialists and 40 hospitals. Each site should enrol 4-20 patients

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 )
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
Period from inclusion up to 9 months (average time period )

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Real-life data on patient outcomes by line of treatment (i.e. 1st vs. 2nd vs. 3rd line).
Time Frame: Every 3 months
Including overall survival (OS), progression-free survival (PFS),time to progression (TTP), response rate (RR) and clinical benefit rate (CBR)
Every 3 months
Real-life pharmacoeconomic data and use of health care resources.
Time Frame: Every 3 months
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
Every 3 months
Health-related quality of life (HRQoL) in patients undergoing treatment with Faslodex 500 mg or exemestane.
Time Frame: Every 3 months
Health-related quality of life will be assessed with a patient-based instrument (eg, EQ5D).
Every 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicolai Maass, Prof. Dr. med., 52074 Aachen, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIS-ODE-FAS-2009/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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