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

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

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
        • Research Site
      • 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
        • Research Site
      • Frechen, Germany
        • Research Site
      • Freiburg, Germany
        • Research Site
      • Furstenwalde, Germany
        • Research Site
      • Geesthacht, Germany
        • Research Site
      • Gera, Germany
        • Research Site
      • Goslar, Germany
        • Research Site
      • Gottingen, Germany
        • Research Site
      • Grobenzell, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Hanau, Germany
        • Research Site
      • Hannover, Germany
        • Research Site
      • Heidelberg, Germany
        • Research Site
      • Heidenheim, Germany
        • Research Site
      • Herdecke, Germany
        • Research Site
      • Hof, Germany
        • Research Site
      • Ilsede, Germany
        • Research Site
      • Ingolstadt, Germany
        • Research Site
      • Karlsruhe, Germany
        • Research Site
      • Kassel, Germany
        • Research Site
      • Kiel, Germany
        • Research Site
      • Koln, Germany
        • Research Site
      • Landshut, Germany
        • Research Site
      • Langen, Germany
        • Research Site
      • Lehrte, Germany
        • Research Site
      • Lubeck, Germany
        • Research Site
      • Ludwigsburg, Germany
        • Research Site
      • Magdeburg, Germany
        • Research Site
      • Mayen, Germany
        • Research Site
      • Memmingen, Germany
        • Research Site
      • 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
        • Research Site
      • Passau, Germany
        • Research Site
      • Pluderhausen, Germany
        • Research Site
      • Remagen, Germany
        • Research Site
      • Remscheid, Germany
        • Research Site
      • Rendsburg, Germany
        • Research Site
      • 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

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
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

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

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

AstraZeneca

Investigators

  • 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

August 1, 2010

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

June 23, 2010

First Submitted That Met QC Criteria

July 27, 2010

First Posted (Estimate)

July 28, 2010

Study Record Updates

Last Update Posted (Estimate)

February 27, 2014

Last Update Submitted That Met QC Criteria

February 26, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Subscribe