Breast CancerCOMPACTNCT00857012

Arimidex: Compliance and Arthralgias in Clinical Therapy (COMPACT)

An observational study of Breast Cancer, run by AstraZeneca at 383 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
How many people: 2,313 participants
Where: 383 sitesGermany
Study dates: Apr 2009to Feb 2012
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Study population: The patient population will include postmenopausal women with hormone-receptor positive primary breast cancer receiving adjuvant endocrine treatment with anastrozole upfront or following two to three years of tamoxifen therapy ("switch") according to the current SmPC (Appendix C). Patients will have received anastrozole treatment for at least 3 months and up to 6 months before the start of the study.

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

383 sites in 1 country.

City, postcode or hospital

300 sites in 1 country

Germany300 sites

Research Site
Aachen, Germany
Research Site
Aalen, Germany
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Ahaus, Germany
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Albstadt, Germany
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Altötting, Germany
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Alzey, Germany
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Amberg, Germany
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Apolda, Germany
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Aschaffenburg, Germany
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Aschersleben, Germany
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Augsburg, Germany
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Aurich, Germany
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Babenhausen, Germany
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Bad Dürkheim, Germany
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Bad Herrenalb, Germany
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Bad Nauheim, Germany
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Bad Neuenahr-Ahrweiler, Germany
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Bad Oeynhausen, Germany
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Bad Oldesloe, Germany
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Bad Reichenhall, Germany
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Bad Saarow, Germany
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Bad Segeberg, Germany
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Bad Tölz, Germany
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Bad Urach, Germany
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Bad Wildbad, Germany
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Bad Wildungen, Germany
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Bad Windsheim, Germany
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Baden-Baden, Germany
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Bamberg, Germany
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Bautzen, Germany
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Bayreuth, Germany
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Berlin, Germany
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Bexbach, Germany
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Biberach, Germany
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Biedenkopf, Germany
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Bielefeld, Germany
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Bietigheim-Bissingen, Germany
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Blankenburg, Germany
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Blumberg in Baden, Germany
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Böblingen, Germany
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Bocholt, Germany
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Bochum, Germany
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Bonn, Germany
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Borna, Germany
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Bottrop, Germany
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Brackenheim, Germany
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Bramsche, Germany
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Brandenburg, Germany
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Braunschweig, Germany
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Bretten, Germany
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Bruchsal, Germany
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Brühl, Germany
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Bühl, Germany
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Bünde, Germany
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Burg, Germany
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Burghausen, Germany
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Celle, Germany
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Chemnitz, Germany
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Cloppenburg, Germany
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Coburg, Germany
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Coesfeld, Germany
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Cologne, Germany
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Dachau, Germany
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Damme, Germany
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Datteln, Germany
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Demmin, Germany
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Dessau, Germany
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Dießen, Germany
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Dillenburg, Germany
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Dillingen, Germany
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Dinkelsbühl, Germany
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Ditzingen, Germany
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Doberlug-Kirchhain, Germany
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Dornstadt, Germany
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Dorsten, Germany
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Dortmund, Germany
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Dreieich, Germany
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Dresden, Germany
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Duisburg, Germany
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Düren, Germany
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Düsseldorf, Germany
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Ebermannstadt, Germany
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Ebersbach, Germany
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Eggenfelden, Germany
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Eisenach, Germany
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Ellwangen, Germany
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Elmshorn, Germany
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Emmendingen, Germany
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Erding, Germany
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Erfurt, Germany
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Ergolding, Germany
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Erkelenz, Germany
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Eschweiler, Germany
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Esens, Germany
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Essen, Germany
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Ettlingen, Germany
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Euskirchen, Germany
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Eutin, Germany
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Feuchtwangen, Germany
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Flensburg, Germany
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Frankenberg, Germany
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Frankenthal, Germany
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Frankfurt (Oder), Germany
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Frechen, Germany
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Freiburg im Breisgau, Germany
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Freising, Germany
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Freital, Germany
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Freyung, Germany
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Friedrichshafen, Germany
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Fulda, Germany
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Fürstenfeldbruck, Germany
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Fürstenwalde, Germany
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Fürth, Germany
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Garbsen, Germany
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Geesthacht, Germany
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Geilenkirchen, Germany
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Gelsenkirchen, Germany
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Georgsmarienhütte, Germany
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Gera, Germany
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Geretsried, Germany
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Gerlingen, Germany
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Gersthofen, Germany
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Giesen, Germany
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Gifhorn, Germany
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Gladbeck, Germany
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Göppingen, Germany
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Goslar, Germany
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Göttingen, Germany
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Gräfelfing, Germany
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Griesheim, Germany
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Gummersbach, Germany
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Günzburg, Germany
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Güstrow, Germany
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Haiger, Germany
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Halberstadt, Germany
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Halle, Germany
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Hamburg, Germany
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Hamelin, Germany
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Hamm, Germany
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Hanover, Germany
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Hansestadt Salzwedel, Germany
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Hartha, Germany
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Heide, Germany
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Heidelberg, Germany
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Heidenheim, Germany
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Heilbronn, Germany
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Heinsberg, Germany
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Hemmingen, Germany
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Henstedt-Ulzburg, Germany
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Heppenheim an der Bergstrasse, Germany
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Herborn, Germany
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Herbrechtingen, Germany
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Herdecke, Germany
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Herford, Germany
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Hermsdorf, Germany
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Herne, Germany
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Herzberg, Germany
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Herzberg am Harz, Germany
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Hessisch Oldendorf, Germany
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Hilchenbach, Germany
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Hildesheim, Germany
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Hillesheim, Germany
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Hochstadt, Germany
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Hof, Germany
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Hofheim, Germany
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Holzminden, Germany
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Homburg/Saar, Germany
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Hückelhoven, Germany
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Ilsede, Germany
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Ingolstadt, Germany
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Isny, Germany
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Itzehoe, Germany
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Jena, Germany
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Kahla, Germany
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Kalkar, Germany
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Karlsbad, Germany
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Karlsruhe, Germany
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Kassel, Germany
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Kaufbeuren, Germany
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Kempten, Germany
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Kerpen, Germany
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Kiel, Germany
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Koblenz, Germany
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Königs Wusterhausen, Germany
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Konstanz, Germany
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Korntal, Germany
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Krefeld, Germany
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Kreuzberg, Germany
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Kreuztal, Germany
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Krumbach, Germany
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Künzelsau, Germany
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Kusel, Germany
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Laatzen, Germany
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Lahnstein, Germany
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Landau, Germany
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Landshut, Germany
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Langen, Germany
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Langenhagen, Germany
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Lauf, Germany
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Lehrte, Germany
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Leichlingen, Germany
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Leipzig, Germany
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Leisnig, Germany
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Leonberg, Germany
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Leverkusen, Germany
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Lich, Germany
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Limburg, Germany
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Lingen, Germany
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Löbau, Germany
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Lohsa OT Weisskollm, Germany
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Lübeck, Germany
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Ludwigsfelde, Germany
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Ludwigshafen, Germany
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Lüneburg, Germany
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Lünen, Germany
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Magdeburg, Germany
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Mannheim, Germany
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Marburg, Germany
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Marienheide, Germany
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Markranstädt, Germany
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Marktredwitz, Germany
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Marl, Germany
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Mayen, Germany
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Meiningen, Germany
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Meissen, Germany
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Memmingen, Germany
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Mendig, Germany
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Mettingen, Germany
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Metzingen, Germany
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Minden, Germany
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Mittweida, Germany
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Moers, Germany
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Mönchengladbach, Germany
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Mühldorf, Germany
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Mühlhausen, Germany
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Mühlheim, Germany
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Mulheim A. D. Ruhr, Germany
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München, Germany
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Münster, Germany
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Mutlangen, Germany
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Nauen, Germany
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Naunhof, Germany
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Neckarsulm, Germany
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Netphen, Germany
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Neubrandenburg, Germany
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Neuhaus am Rennweg, Germany
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Neumarkt, Germany
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Neumünster, Germany
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Neuruppin, Germany
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Neustadt, Germany
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Neustadt an der Weinstraße, Germany
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Nienburg, Germany
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Nordhausen, Germany
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Nordhorn, Germany
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Nümbrecht, Germany
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Nuremberg, Germany
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Nürtingen, Germany
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Oberhausen, Germany
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Oberstdorf, Germany
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Ochsenfurt, Germany
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Offenbach, Germany
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Offenburg, Germany
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Oranienburg, Germany
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Osnabrück, Germany
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Paderborn, Germany
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Parchim, Germany
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Passau, Germany
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Peine, Germany
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Penzberg, Germany
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Pfinztal, Germany
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Pforzheim, Germany
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Pfullingen, Germany
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Pinneberg, Germany
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Pirmasens, Germany
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Plauen-Kauschwitz, Germany
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Pocking, Germany
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Potsdam, Germany
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Quickborn, Germany
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Rahden, Germany
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Rangsdorf, Germany
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Ravensburg, Germany
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Recklinghausen, Germany
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Regensburg, Germany
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Reinbek, Germany
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Remchingen, Germany
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Remscheid, Germany
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Rendsburg, Germany
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Reutlingen, Germany
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Rheine, Germany
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Rheinfelden, Germany
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Riebnitz-Damgarten, Germany
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Riesa, Germany
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Rodewisch, Germany
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Rodgau, Germany
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Rosenheim, Germany
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Rösrath, Germany
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Rotenburg (Wümme), Germany
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Rottenburg, Germany
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Rottweil, Germany
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Saarbrücken, Germany

Other trials in Germany

About this study

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

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.

Read the detailed 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.

Conditions: Breast Cancer
Keywords: Primary early MCa, Arimidex
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00857012
Study group	Role	What they receive
All patients		treated with Anastrozole as per SPC

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 months

Secondary outcomes (5)

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.
Measured: 12 months
Retrospective assessment of incidence of pre-existing arthralgias before start of anastrozole treatment, stratified by upfront and switch therapy.
Measured: 12 months
Descriptive assessment of arthralgia therapy and of costs of arthralgia therapy, stratified by upfront and switch therapy.
Measured: 12 months
Identification of factors influencing and correlating to treatment-emergent arthralgias
Measured: 12 months
Assessment of safety and tolerability of anastrozole.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2009Feb 2012

First posted6 Mar 2009 (estimated)
Study startApr 2009
Study completionFeb 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 2,313 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00857012
Sponsor's protocol ID: NIS-ODE-ARI-2008/1
Acronym: COMPACT
Status last verified: Nov 2012
First submitted: 5 Mar 2009
Last updated: 12 Nov 2012
Results posted: No
Data monitoring committee: No

Publications

Hadji P, Jackisch C, Bolten W, Blettner M, Hindenburg HJ, Klein P, Konig K, Kreienberg R, Rief W, Wallwiener D, Zaun S, Harbeck N. COMPliance and Arthralgia in Clinical Therapy: the COMPACT trial, assessing the incidence of arthralgia, and compliance within the first year of adjuvant anastrozole therapy. Ann Oncol. 2014 Feb;25(2):372-7. doi: 10.1093/annonc/mdt513. Epub 2013 Dec 18.
PubMed 24355487

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00857012
Acronym / sponsor ID: COMPACT / NIS-ODE-ARI-2008/1
Conditions: Breast Cancer
Keywords: Primary early MCa, Arimidex
Study type: Observational
Recruitment status: Completed
Enrolment: 2,313 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Apr 2009
Study completion: Feb 2012 (actual)
First posted: 6 Mar 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
All patients	–	–treated with Anastrozole as per SPC

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The patient population will include postmenopausal women with hormone-receptor positive primary breast cancer receiving adjuvant endocrine treatment with anastrozole upfront or following two to three years of tamoxifen therapy ("switch") according to the current SmPC (Appendix C). Patients will have received anastrozole treatment for at least 3 months and up to 6 months before the start of the study.

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.
Time frame: 12 months

5 secondary outcomes

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.
Time frame: 12 months
Retrospective assessment of incidence of pre-existing arthralgias before start of anastrozole treatment, stratified by upfront and switch therapy.
Time frame: 12 months
Descriptive assessment of arthralgia therapy and of costs of arthralgia therapy, stratified by upfront and switch therapy.
Time frame: 12 months
Identification of factors influencing and correlating to treatment-emergent arthralgias
Time frame: 12 months
Assessment of safety and tolerability of anastrozole.
Time frame: 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2012.
Derived from this study: PubMed 24355487Hadji P, Jackisch C, Bolten W, Blettner M, Hindenburg HJ, Klein P, Konig K, Kreienberg R, Rief W, Wallwiener D, Zaun S, Harbeck N. COMPliance and Arthralgia in Clinical Therapy: the COMPACT trial, assessing the incidence of arthralgia, and compliance within the first year of adjuvant anastrozole therapy. Ann Oncol. 2014 Feb;25(2):372-7. doi: 10.1093/annonc/mdt513. Epub 2013 Dec 18.

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Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

H Brasch study director

AstraZeneca, Germany

383 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by AstraZeneca at 383 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 383 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00857012, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2012.