Clinical trial NCT01171417: A Treatment With Fulvestrant and Exemestane in Postmenopausal Patients With Advanced Hormone Receptor-Positive (HR) + Breast Cancer
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postmenopause
Breast Cancer
Keywords: Fulvestrant
Exemestane
postmenopausal patients
advanced HR+ breast cancer
Hormone Receptor positive
advanced breast cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-07-28
Enrollment: 570
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the effectiveness of Faslodex 500 mg in terms of time to progression (TTP) of disease.
timeFrame: Period from inclusion up to 9 months (average time period )
measure: Disease management data
timeFrame: Period from inclusion up to 9 months (average time period )
Secondary outcomes:
measure: Real-life data on patient outcomes by line of treatment (i.e. 1st vs. 2nd vs. 3rd line).
timeFrame: Every 3 months
measure: Real-life pharmacoeconomic data and use of health care resources.
timeFrame: Every 3 months
measure: Health-related quality of life (HRQoL) in patients undergoing treatment with Faslodex 500 mg or exemestane.
timeFrame: Every 3 months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Research Site
city: Ahaus
country: Germany
facility: Research Site
city: Amberg
country: Germany
facility: Research Site
city: Aschaffenburg
country: Germany
facility: Research Site
city: Aschersleben
country: Germany
facility: Research Site
city: Bad Nauheim
country: Germany
facility: Research Site
city: Bad Segeberg
country: Germany
facility: Research Site
city: Bamberg
country: Germany
facility: Research Site
city: Bergisch Gladbach
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bielefeld
country: Germany
facility: Research Site
city: Boblingen
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Braunschweig
country: Germany
facility: Research Site
city: Castrop-Rauxel
country: Germany
facility: Research Site
city: Chemnitz
country: Germany
facility: Research Site
city: Dachau
country: Germany
facility: Research Site
city: Donauwurth
country: Germany
facility: Research Site
city: Dortmund
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Dusseldorf
country: Germany
facility: Research Site
city: Eggenfelden
country: Germany
facility: Research Site
city: Erfurt
country: Germany
facility: Research Site
city: Eschweiler
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Esslingen
country: Germany
facility: Research Site
city: Euskirchen
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Frechen
country: Germany
facility: Research Site
city: Freiburg
country: Germany
facility: Research Site
city: Furstenwalde
country: Germany
facility: Research Site
city: Geesthacht
country: Germany
facility: Research Site
city: Gera
country: Germany
facility: Research Site
city: Goslar
country: Germany
facility: Research Site
city: Gottingen
country: Germany
facility: Research Site
city: Grobenzell
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hanau
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Heidenheim
country: Germany
facility: Research Site
city: Herdecke
country: Germany
facility: Research Site
city: Hof
country: Germany
facility: Research Site
city: Ilsede
country: Germany
facility: Research Site
city: Ingolstadt
country: Germany
facility: Research Site
city: Karlsruhe
country: Germany
facility: Research Site
city: Kassel
country: Germany
facility: Research Site
city: Kiel
country: Germany
facility: Research Site
city: Koln
country: Germany
facility: Research Site
city: Landshut
country: Germany
facility: Research Site
city: Langen
country: Germany
facility: Research Site
city: Lehrte
country: Germany
facility: Research Site
city: Lubeck
country: Germany
facility: Research Site
city: Ludwigsburg
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: Mayen
country: Germany
facility: Research Site
city: Memmingen
country: Germany
facility: Research Site
city: Mittweida
country: Germany
facility: Research Site
city: Moers
country: Germany
facility: Research Site
city: Monchengladbach
country: Germany
facility: Research Site
city: Muhlhausen
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Munster
country: Germany
facility: Research Site
city: Naunhof
country: Germany
facility: Research Site
city: Nordhausen
country: Germany
facility: Research Site
city: Nordhorn
country: Germany
facility: Research Site
city: Nurnberg
country: Germany
facility: Research Site
city: Oberhausen
country: Germany
facility: Research Site
city: Offenbach
country: Germany
facility: Research Site
city: Osnabruck
country: Germany
facility: Research Site
city: Passau
country: Germany
facility: Research Site
city: Pluderhausen
country: Germany
facility: Research Site
city: Remagen
country: Germany
facility: Research Site
city: Remscheid
country: Germany
facility: Research Site
city: Rendsburg
country: Germany
facility: Research Site
city: Rodewisch
country: Germany
facility: Research Site
city: Rodgau
country: Germany
facility: Research Site
city: Simmern
country: Germany
facility: Research Site
city: Soest
country: Germany
facility: Research Site
city: Stendal
country: Germany
facility: Research Site
city: Stralsund
country: Germany
facility: Research Site
city: Stuttgart
country: Germany
facility: Research Site
city: Troisdorf
country: Germany
facility: Research Site
city: Tubingen
country: Germany
facility: Research Site
city: Villingen-Schwenningen
country: Germany
facility: Research Site
city: Weiden
country: Germany
facility: Research Site
city: Wetzlar
country: Germany
facility: Research Site
city: Wiesbaden
country: Germany
facility: Research Site
city: Worms
country: Germany
facility: Research Site
city: Wurselen
country: Germany
facility: Research Site
city: Wurzburg
country: Germany
facility: Research Site
city: Zittau
country: Germany
facility: Research Site
Study officials:
affiliation: 52074 Aachen, Germany
name: Nicolai Maass, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: