Arimidex: Compliance and Arthralgias in Clinical Therapy (COMPACT)

Breast Cancer Clinical Trial

— COMPACT  

Official title:

Arimidex: Compliance and Arthralgias in Clinical Therapy (COMPACT): An in Practice Assessment of Arthralgias and Related Costs as Well as Compliance in the First Year of Anastrozole Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00857012
• Other study ID #: NIS-ODE-ARI-2008/1
• Status: Completed
• Phase: N/A
• First received: March 5, 2009
• Last updated: November 9, 2012
• Start date: April 2009
• Est. completion date: February 2012

Study information

• Verified date: November 2012
• 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

Patients are eligible for inclusion in this NIS if they have taken anastrozole either upfront or following two to three years of tamoxifen treatment ("switch") for at least three and not more than six months prior to offering an individual participation in this program. Treatment should follow local therapy guidelines and standard practice. Treatment decisions for patients participating in this study including assessments or supportive therapy during follow-up visits will also follow guidelines and remain independent of the program.

Description:

The patient population will include postmenopausal women with hormone-receptor positive primary breast cancer scheduled for adjuvant upfront endocrine treatment with anastrozole or following two to three years of tamoxifen treatment ("switch") according to the current SmPC (Appendix C). Patients will have taken anastrozole for at least three months and not more than six months before the start of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2313
• Est. completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Postmenopausal women aged 18 years or older; Postmenopause is defined as Natural menopause with menses >1 year ago or Serum FSH (> 20 IU/ l), and E2 levels in the postmenopausal range or patients who had bilateral oophorectomy

• Histologically / cytologically confirmed primary diagnosis of early breast cancer (M0) with hormone sensitive tumour (ER+ve and/or PgR+ve)

• Patients, who underwent breast cancer surgery and, if appl. radiation therapy and/or neo/adjuvant chemotherapy and have taken adjuvant endocrine treatment with anastrozole (upfront or following two to three years of tamoxifen) min 3 max 6 months

• In case of a previous therapy with tamoxifen (switch-therapy), duration of tamoxifen treatment for at least two and up to three years.

Exclusion Criteria:

• Patients with severe renal function disorders (Creatinine clearance < 20 ml/min or Patients with moderate or severe disorders of hepatic function

• Concomitant treatment with drugs known to affect sex hormonal status and tamoxifen

• Patients with ductal carcinoma in situ (DCIS) without primary diagnosis of early breast cancer (M0)

• Evidence of any significant clinical disorder or laboratory finding which in the opinion of the investigator, makes it undesirable for the patient to participate in the program

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthralgia
• Breast Cancer

Locations

Country	Name	City	State
Germany	Research Site	Aachen
Germany	Research Site	Aalen
Germany	Research Site	Ahaus
Germany	Research Site	Albstadt
Germany	Research Site	Altotting
Germany	Research Site	Alzey
Germany	Research Site	Amberg
Germany	Research Site	Apolda
Germany	Research Site	Aschaffenburg
Germany	Research Site	Aschersleben
Germany	Research Site	Augsburg
Germany	Research Site	Aurich
Germany	Research Site	Babenhausen
Germany	Research Site	Bad Durkheim
Germany	Research Site	Bad Herrenalb
Germany	Research Site	Bad Nauheim
Germany	Research Site	Bad Neuenahr-Ahrweiler
Germany	Research Site	Bad Oeynhausen
Germany	Research Site	Bad Oldesloe
Germany	Research Site	Bad Reichenhall
Germany	Research Site	Bad Saarow
Germany	Research Site	Bad Segeberg
Germany	Research Site	Bad Tolz
Germany	Research Site	Bad Urach
Germany	Research Site	Bad Wildbad
Germany	Research Site	Bad Wildungen
Germany	Research Site	Bad Windsheim
Germany	Research Site	Baden-Baden
Germany	Research Site	Bamberg
Germany	Research Site	Bautzen
Germany	Research Site	Bayreuth
Germany	Research Site	Berlin
Germany	Research Site	Berlin-Kreuzberg
Germany	Research Site	Berlin-Steglitz
Germany	Research Site	Bexbach
Germany	Research Site	Biberach
Germany	Research Site	Biedenkopf
Germany	Research Site	Bielefeld
Germany	Research Site	Bietigheim-Bissingen
Germany	Research Site	Blankenburg
Germany	Research Site	Blumberg in Baden
Germany	Research Site	Boblingen
Germany	Research Site	Bocholt
Germany	Research Site	Bochum
Germany	Research Site	Bonn
Germany	Research Site	Borna
Germany	Research Site	Bottrop
Germany	Research Site	Brackenheim
Germany	Research Site	Bramsche
Germany	Research Site	Brandenburg
Germany	Research Site	Braunschweig
Germany	Research Site	Bretten
Germany	Research Site	Bruchsal
Germany	Research Site	Bruhl
Germany	Research Site	Buhl
Germany	Research Site	Bunde
Germany	Research Site	Burg
Germany	Research Site	Burghausen
Germany	Research Site	Celle
Germany	Research Site	Chemnitz
Germany	Research Site	Cloppenburg
Germany	Research Site	Coburg
Germany	Research Site	Coesfeld
Germany	Research Site	Dachau
Germany	Research Site	Damme
Germany	Research Site	Datteln
Germany	Research Site	Demmin
Germany	Research Site	Dessau
Germany	Research Site	Dessau-Rosslau
Germany	Research Site	Diessen
Germany	Research Site	Dillenburg
Germany	Research Site	Dillingen
Germany	Research Site	Dinkelsbuhl
Germany	Research Site	Ditzingen
Germany	Research Site	Doberlug-Kirchhain
Germany	Research Site	Dornstadt
Germany	Research Site	Dorsten
Germany	Research Site	Dortmund
Germany	Research Site	Dreieich
Germany	Research Site	Dresden
Germany	Research Site	Duisburg
Germany	Research Site	Duren
Germany	Research Site	Dusseldorf
Germany	Research Site	Ebermannstadt
Germany	Research Site	Ebersbach
Germany	Research Site	Eggenfelden
Germany	Research Site	Eisenach
Germany	Research Site	Ellwangen
Germany	Research Site	Elmshorn
Germany	Research Site	Emmendingen
Germany	Research Site	Erding
Germany	Research Site	Erfurt
Germany	Research Site	Ergolding
Germany	Research Site	Erkelenz
Germany	Research Site	Eschweiler
Germany	Research Site	Esens
Germany	Research Site	Essen
Germany	Research Site	Ettlingen
Germany	Research Site	Euskirchen
Germany	Research Site	Eutin
Germany	Research Site	Feuchtwangen
Germany	Research Site	Flensburg
Germany	Research Site	Frankenberg
Germany	Research Site	Frankenthal
Germany	Research Site	Frankfurt (Oder)
Germany	Research Site	Frechen
Germany	Research Site	Freiburg
Germany	Research Site	Freising
Germany	Research Site	Freital
Germany	Research Site	Freyung
Germany	Research Site	Friedrichshafen
Germany	Research Site	Fulda
Germany	Research Site	Furstenfeldbruck
Germany	Research Site	Furstenwalde
Germany	Research Site	Furth
Germany	Research Site	Garbsen
Germany	Research Site	Geesthacht
Germany	Research Site	Geilenkirchen
Germany	Research Site	Gelsenkirchen
Germany	Research Site	Georgsmarienhutte
Germany	Research Site	Gera
Germany	Research Site	Geretsried
Germany	Research Site	Gerlingen
Germany	Research Site	Gersthofen
Germany	Research Site	Giesen
Germany	Research Site	Gifhorn
Germany	Research Site	Gladbeck
Germany	Research Site	Goppingen
Germany	Research Site	Goslar
Germany	Research Site	Gottingen
Germany	Research Site	Grafelfing
Germany	Research Site	Griesheim
Germany	Research Site	Gummersbach
Germany	Research Site	Gunzburg
Germany	Research Site	Gustrow
Germany	Research Site	Haiger
Germany	Research Site	Halberstadt
Germany	Research Site	Halle
Germany	Research Site	Halle / Saale
Germany	Research Site	Hamburg
Germany	Research Site	Hameln
Germany	Research Site	Hamm
Germany	Research Site	Hannover
Germany	Research Site	Hartha
Germany	Research Site	Heide
Germany	Research Site	Heidelberg
Germany	Research Site	Heidenheim
Germany	Research Site	Heilbronn
Germany	Research Site	Heinsberg
Germany	Research Site	Hemmingen
Germany	Research Site	Henstedt-Ulzburg
Germany	Research Site	Heppenheim
Germany	Research Site	Herborn
Germany	Research Site	Herbrechtingen
Germany	Research Site	Herdecke
Germany	Research Site	Herford
Germany	Research Site	Hermsdorf
Germany	Research Site	Herne
Germany	Research Site	Herzberg
Germany	Research Site	Herzberg am Harz
Germany	Research Site	Hessisch Oldendorf
Germany	Research Site	Hilchenbach
Germany	Research Site	Hildesheim
Germany	Research Site	Hillesheim
Germany	Research Site	Hochstadt
Germany	Research Site	Hof
Germany	Research Site	Hofheim
Germany	Research Site	Holzminden
Germany	Research Site	Homburg/Saar
Germany	Research Site	Huckelhoven
Germany	Research Site	Ilsede
Germany	Research Site	Ingolstadt
Germany	Research Site	Isny
Germany	Research Site	Itzehoe
Germany	Research Site	Jena
Germany	Research Site	Kahla
Germany	Research Site	Kalkar
Germany	Research Site	Karlsbad
Germany	Research Site	Karlsruhe
Germany	Research Site	Kassel
Germany	Research Site	Kaufbeuren
Germany	Research Site	Kempten
Germany	Research Site	Kerpen
Germany	Research Site	Kiel
Germany	Research Site	Koblenz
Germany	Research Site	Koln
Germany	Research Site	Konigs Wusterhausen
Germany	Research Site	Konstanz
Germany	Research Site	Korntal-Munchingen
Germany	Research Site	Krefeld
Germany	Research Site	Kreuztal
Germany	Research Site	Krumbach
Germany	Research Site	Kunzelsau
Germany	Research Site	Kusel
Germany	Research Site	Laatzen
Germany	Research Site	Lahnstein
Germany	Research Site	Landau
Germany	Research Site	Landshut
Germany	Research Site	Langen
Germany	Research Site	Langenhagen
Germany	Research Site	Lauf
Germany	Research Site	Lehrte
Germany	Research Site	Leichlingen
Germany	Research Site	Leipzig
Germany	Research Site	Leisnig
Germany	Research Site	Leonberg
Germany	Research Site	Leverkusen
Germany	Research Site	Lich
Germany	Research Site	Limburg
Germany	Research Site	Lingen
Germany	Research Site	Lobau
Germany	Research Site	Lohsa OT Weisskollm
Germany	Research Site	Lubeck
Germany	Research Site	Ludwigsfelde
Germany	Research Site	Ludwigshafen
Germany	Research Site	Luneburg
Germany	Research Site	Lunen
Germany	Research Site	Magdeburg
Germany	Research Site	Mannheim
Germany	Research Site	Marburg
Germany	Research Site	Marienheide
Germany	Research Site	Markranstadt
Germany	Research Site	Marktredwitz
Germany	Research Site	Marl
Germany	Research Site	Mayen
Germany	Research Site	Meiningen
Germany	Research Site	Meissen
Germany	Research Site	Memmingen
Germany	Research Site	Mendig
Germany	Research Site	Mettingen
Germany	Research Site	Metzingen
Germany	Research Site	Minden
Germany	Research Site	Mittweida
Germany	Research Site	Moers
Germany	Research Site	Monchengladbach
Germany	Research Site	Muhldorf
Germany	Research Site	Muhlhausen
Germany	Research Site	Muhlheim
Germany	Research Site	Mulheim a. d. Ruhr
Germany	Research Site	Munchen
Germany	Research Site	Munster
Germany	Research Site	Mutlangen
Germany	Research Site	Nauen
Germany	Research Site	Naunhof
Germany	Research Site	Neckarsulm
Germany	Research Site	Netphen
Germany	Research Site	Neubrandenburg
Germany	Research Site	Neuhaus am Rennweg
Germany	Research Site	Neumarkt
Germany	Research Site	Neumunster
Germany	Research Site	Neuruppin
Germany	Research Site	Neustadt
Germany	Research Site	Neustadt an der Weinstrasse
Germany	Research Site	Nienburg
Germany	Research Site	Nordhausen
Germany	Research Site	Nordhorn
Germany	Research Site	Numbrecht
Germany	Research Site	Nurnberg
Germany	Research Site	Nurtingen
Germany	Research Site	Oberhausen
Germany	Research Site	Oberstdorf
Germany	Research Site	Ochsenfurt
Germany	Research Site	Offenbach
Germany	Research Site	Offenburg
Germany	Research Site	Oranienburg
Germany	Research Site	Osnabruck
Germany	Research Site	Paderborn
Germany	Research Site	Parchim
Germany	Research Site	Passau
Germany	Research Site	Peine
Germany	Research Site	Penzberg
Germany	Research Site	Pfinztal
Germany	Research Site	Pforzheim
Germany	Research Site	Pfullingen
Germany	Research Site	Pinneberg
Germany	Research Site	Pirmasens
Germany	Research Site	Plauen-Kauschwitz
Germany	Research Site	Pocking
Germany	Research Site	Potsdam
Germany	Research Site	Quickborn
Germany	Research Site	Rahden
Germany	Research Site	Rangsdorf
Germany	Research Site	Ravensburg
Germany	Research Site	Recklinghausen
Germany	Research Site	Regensburg
Germany	Research Site	Reinbek
Germany	Research Site	Remchingen
Germany	Research Site	Remscheid
Germany	Research Site	Rendsburg
Germany	Research Site	Reutlingen
Germany	Research Site	Rheine
Germany	Research Site	Rheinfelden
Germany	Research Site	Riebnitz-Damgarten
Germany	Research Site	Riesa
Germany	Research Site	Rodewisch
Germany	Research Site	Rodgau
Germany	Research Site	Rosenheim
Germany	Research Site	Rosrath
Germany	Research Site	Rotenburg
Germany	Research Site	Rottenburg
Germany	Research Site	Rottweil
Germany	Research Site	Saarbrucken
Germany	Research Site	Saarlouis
Germany	Research Site	Salzgitter
Germany	Research Site	Salzwedel
Germany	Research Site	Sandhausen
Germany	Research Site	Sayda
Germany	Research Site	Schalksmuhle
Germany	Research Site	Scheibenberg
Germany	Research Site	Schkeuditz
Germany	Research Site	Schleswig
Germany	Research Site	Schonaich
Germany	Research Site	Schonebeck
Germany	Research Site	Schorndorf
Germany	Research Site	Schwabach
Germany	Research Site	Schwabisch Hall
Germany	Research Site	Schwandorf
Germany	Research Site	Schweinfurt
Germany	Research Site	Schwerin
Germany	Research Site	Schwerte
Germany	Research Site	Schwetzingen
Germany	Research Site	Sebnitz
Germany	Research Site	Senden
Germany	Research Site	Siegen
Germany	Research Site	Simmern
Germany	Research Site	Singen (Hohentwiel)
Germany	Research Site	Sogel
Germany	Research Site	Solingen
Germany	Research Site	Sommerda
Germany	Research Site	Spremberg
Germany	Research Site	Sprockhovel
Germany	Research Site	St. Wendel
Germany	Research Site	Starnberg
Germany	Research Site	Stendal
Germany	Research Site	Stockelsdorf
Germany	Research Site	Stralsund
Germany	Research Site	Stuhr
Germany	Research Site	Stuttgart
Germany	Research Site	Sulzbach-Rosenberg
Germany	Research Site	Teltow
Germany	Research Site	Tettnang
Germany	Research Site	Torgau
Germany	Research Site	Tornesch
Germany	Research Site	Tubingen
Germany	Research Site	Uelzen
Germany	Research Site	Uetze
Germany	Research Site	Ulm
Germany	Research Site	Vechta
Germany	Research Site	Vechta-Langforden
Germany	Research Site	Veitshochheim
Germany	Research Site	Viersen
Germany	Research Site	Villingen-Schwenningen
Germany	Research Site	Vilsbiburg
Germany	Research Site	Vlotho
Germany	Research Site	Vohringen
Germany	Research Site	Volklingen
Germany	Research Site	Waldmunchen
Germany	Research Site	Walsrode
Germany	Research Site	Wangen
Germany	Research Site	Warburg
Germany	Research Site	Warendorf
Germany	Research Site	Warin
Germany	Research Site	Wasserburg
Germany	Research Site	Weiden in der Oberpfalz
Germany	Research Site	Weingarten
Germany	Research Site	Wermelskirchen
Germany	Research Site	Werneck
Germany	Research Site	Wertheim
Germany	Research Site	Wetzlar
Germany	Research Site	Wiesbaden
Germany	Research Site	Wilster
Germany	Research Site	Wismar
Germany	Research Site	Witten
Germany	Research Site	Witterda
Germany	Research Site	Wolfen
Germany	Research Site	Wolfsburg
Germany	Research Site	Worms
Germany	Research Site	Wuppertal
Germany	Research Site	Wurselen
Germany	Research Site	Wurzburg
Germany	Research Site	Zittau
Germany	Research Site	Zossen
Germany	Research Site	Zwickau
Germany	Research Site	Zwiesel
Germany	Research Site	Zwonitz

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of arthralgia scores and patients` compliance within the first year of anastrozole treatment, stratified by upfront and switch therapy as well as assessment of the relationship between compliance and arthralgia scores.		12 months	Yes
Secondary	Incidence of arthralgia and arthralgia characteristics within the 1st year of anastrozole therapy stratified by upfront and switch therapy and assessment of the relationship of arthralgia incidence and arthralgia characteristics to patients compliance.		12 months	Yes
Secondary	Retrospective assessment of incidence of pre-existing arthralgias before start of anastrozole treatment, stratified by upfront and switch therapy.		12 months	Yes
Secondary	Descriptive assessment of arthralgia therapy and of costs of arthralgia therapy, stratified by upfront and switch therapy.		12 months	No
Secondary	Identification of factors influencing and correlating to treatment-emergent arthralgias		12 months	No
Secondary	Assessment of safety and tolerability of anastrozole.		12 months	Yes