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

Breast Cancer Clinical Trial

— ACT-FASTER:  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01171417
• Other study ID #: NIS-ODE-FAS-2009/1
• Secondary ID: NIS-ODE-FAS-2009
• Status: Completed
• Phase: N/A
• First received: June 23, 2010
• Last updated: February 26, 2014
• Start date: August 2010
• Est. completion date: November 2013

Study information

• Verified date: February 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 570
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Postmenopause

Locations

Country	Name	City	State
Germany	Research Site	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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the effectiveness of Faslodex 500 mg in terms of time to progression (TTP) of disease.		Period from inclusion up to 9 months (average time period )	No
Primary	Disease management data	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 )	No
Secondary	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)	Every 3 months	No
Secondary	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	Every 3 months	No
Secondary	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).	Every 3 months	No