Spots Global Cancer Trial Database for A Non-interventional Study for Women With HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer to Evaluate the Real-world Effectiveness of Treatment Algorithms Beginning With Ribociclib + AI/FUL, or With Endocrine Therapy or Chemotherapy as First Line Treatment
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Trial Identification
Brief Title: A Non-interventional Study for Women With HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer to Evaluate the Real-world Effectiveness of Treatment Algorithms Beginning With Ribociclib + AI/FUL, or With Endocrine Therapy or Chemotherapy as First Line Treatment
Official Title: A Non-interventional Study for Women With HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer to Evaluate the Real-world Effectiveness of Treatment Algorithms Beginning With Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor/Fulvestrant, or With Endocrine Therapy or Chemotherapy as First Line Treatment
Study ID: NCT06311383
Conditions
Study Description
Brief Summary: This is a non-interventional observational study conducted in Germany to evaluate the real-world effectiveness, tolerability, safety, and quality of life in patients with locally advanced/metastatic HR+/HER2- breast cancer treated with one of the following 1st line treatments: Ribociclib + AI/FUL, or endocrine monotherapy, or chemotherapy
Detailed Description: This non-interventional study collects data from clinical practice capturing on effectiveness, safety and tolerability, duration of therapy, and quality of life of ribociclib in combination with an aromatase inhibitor/fulvestrant in daily routine and in line with the respective current German summary of product characteristics. In order to put these results into perspective, data is also collected on patients treated with endocrine therapy or chemotherapy for first line locally advanced or metastatic breast cancer. To gain insight into algorithms and outcome of sequential therapy, up to three lines of treatment are documented within this study. The information gathered and evaluated in this NIS is helping to answer open questions for the treatment of locally advanced/metastatic breast cancer and provides first insights into the treatment reality with ribociclib in this setting. This includes, but is not limited to, the questions on baseline demographics leading to a specific treatment decision, as well as efficacy and clinical routine related to treatment sequencing. In addition, data on the mutation status (including PIK3CA and BRCA1/2) is collected at different time points to generate insights into the clinical routine of mutation testing and to understand its impact on therapy sequencing.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Novartis Investigative Site, Freudenstadt, Baden Wuerttemberg, Germany
Novartis Investigative Site, Karlsruhe, Baden Wuerttemberg, Germany
Novartis Investigative Site, Mannheim, Baden Wuerttemberg, Germany
Novartis Investigative Site, Nuertingen, Baden Wuerttemberg, Germany
Novartis Investigative Site, Reutlingen, Baden Wuerttemberg, Germany
Novartis Investigative Site, Winnenden, Baden Wuerttemberg, Germany
Novartis Investigative Site, Ostfildern, Baden Württemberg, Germany
Novartis Investigative Site, Baden-Baden, Baden-Wuerttemberg, Germany
Novartis Investigative Site, Mutlangen, Baden-Wuerttemberg, Germany
Novartis Investigative Site, Rottweil, Baden-Wuerttemberg, Germany
Novartis Investigative Site, Schwaebisch, Baden-Wuerttemberg, Germany
Novartis Investigative Site, Sigmaringen, Baden-Wuerttemberg, Germany
Novartis Investigative Site, Augsburg, Bavaria, Germany
Novartis Investigative Site, Bamberg, Bavaria, Germany
Novartis Investigative Site, Muenchen, Bavaria, Germany
Novartis Investigative Site, Altoetting, Bayern, Germany
Novartis Investigative Site, Amberg, Bayern, Germany
Novartis Investigative Site, Ansbach, Bayern, Germany
Novartis Investigative Site, Aschaffenburg, Bayern, Germany
Novartis Investigative Site, Bayreuth, Bayern, Germany
Novartis Investigative Site, Ebersberg, Bayern, Germany
Novartis Investigative Site, Landshut, Bayern, Germany
Novartis Investigative Site, Muenchen, Bayern, Germany
Novartis Investigative Site, Muenchen, Bayern, Germany
Novartis Investigative Site, Nuernberg, Bayern, Germany
Novartis Investigative Site, Regensburg, Bayern, Germany
Novartis Investigative Site, Rosenheim, Bayern, Germany
Novartis Investigative Site, Straubing, Bayern, Germany
Novartis Investigative Site, Wuerzburg, Bayern, Germany
Novartis Investigative Site, Mannheim, Beden Wuerttenberg, Germany
Novartis Investigative Site, Brandenburg A D Havel, Brandenburg, Germany
Novartis Investigative Site, Doberlug Kirchhain, Brandenburg, Germany
Novartis Investigative Site, Fuerstenwalde, Brandenburg, Germany
Novartis Investigative Site, Ludwigsfelde, Brandenburg, Germany
Novartis Investigative Site, Neu-Brandenburg, Brandenburg, Germany
Novartis Investigative Site, Spremberg, Brandenburg, Germany
Novartis Investigative Site, Bremerhaven, Bremen, Germany
Novartis Investigative Site, Bayern, Donauworth, Germany
Novartis Investigative Site, Baden-Württemberg, Heidenheim a.d.B, Germany
Novartis Investigative Site, Bad Homburg, Hessen, Germany
Novartis Investigative Site, Bad Nauheim, Hessen, Germany
Novartis Investigative Site, Darmstadt, Hessen, Germany
Novartis Investigative Site, Erbach, Hessen, Germany
Novartis Investigative Site, Langen, Hessen, Germany
Novartis Investigative Site, Lich, Hessen, Germany
Novartis Investigative Site, Marburg, Hessen, Germany
Novartis Investigative Site, Arnsberg Huesten, Hochsauerland, Germany
Novartis Investigative Site, Twistringen, Lower Saxony, Germany
Novartis Investigative Site, Rostock, Mecklenburg Vorpommern, Germany
Novartis Investigative Site, Schwerin, Mecklenburg Vorpommern, Germany
Novartis Investigative Site, Stralsund, Mecklenburg Vorpommern, Germany
Novartis Investigative Site, Braunschweig, Niedersachsen, Germany
Novartis Investigative Site, Buchholz, Niedersachsen, Germany
Novartis Investigative Site, Damme, Niedersachsen, Germany
Novartis Investigative Site, Georgsmarienhuette, Niedersachsen, Germany
Novartis Investigative Site, Hameln, Niedersachsen, Germany
Novartis Investigative Site, Hannover, Niedersachsen, Germany
Novartis Investigative Site, Lingen, Niedersachsen, Germany
Novartis Investigative Site, Osnabrueck, Niedersachsen, Germany
Novartis Investigative Site, Quedlinburg, Niedersachsen, Germany
Novartis Investigative Site, Westerstede, Niedersachsen, Germany
Novartis Investigative Site, Wolfenbuettel, Niedersachsen, Germany
Novartis Investigative Site, Bergisch Gladbach, Nordrhein Westfalen, Germany
Novartis Investigative Site, Bielefeld, Nordrhein Westfalen, Germany
Novartis Investigative Site, Bielefeld, Nordrhein Westfalen, Germany
Novartis Investigative Site, Bonn, Nordrhein Westfalen, Germany
Novartis Investigative Site, Bonn, Nordrhein Westfalen, Germany
Novartis Investigative Site, Dortmund, Nordrhein Westfalen, Germany
Novartis Investigative Site, Duesseldorf, Nordrhein Westfalen, Germany
Novartis Investigative Site, Duesseldorf, Nordrhein Westfalen, Germany
Novartis Investigative Site, Gelsenkirchen, Nordrhein Westfalen, Germany
Novartis Investigative Site, Herdecke, Nordrhein Westfalen, Germany
Novartis Investigative Site, Hilden, Nordrhein Westfalen, Germany
Novartis Investigative Site, Krefeld, Nordrhein Westfalen, Germany
Novartis Investigative Site, Lemgo, Nordrhein Westfalen, Germany
Novartis Investigative Site, Neuss, Nordrhein Westfalen, Germany
Novartis Investigative Site, Olpe, Nordrhein Westfalen, Germany
Novartis Investigative Site, Paderborn, Nordrhein Westfalen, Germany
Novartis Investigative Site, Siegen, Nordrhein Westfalen, Germany
Novartis Investigative Site, Wesel, Nordrhein Westfalen, Germany
Novartis Investigative Site, Wesel, Nordrhein Westfalen, Germany
Novartis Investigative Site, Witten, Nordrhein Westfalen, Germany
Novartis Investigative Site, Koeln, Nordrhein Westphalen, Germany
Novartis Investigative Site, Bochum, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Dortmund, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Herne, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Remscheid, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Troisdorf, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Velbert, North Rhine-Westphalia, Germany
Novartis Investigative Site, Hagen, Northrhine Westfalia, Germany
Novartis Investigative Site, Remscheid Innen, Northrhine Westfalia, Germany
Novartis Investigative Site, Eggenfelde, Passau, Germany
Novartis Investigative Site, Mayen, Rheinland Pfalz, Germany
Novartis Investigative Site, Simmern, Rheinland Pfalz, Germany
Novartis Investigative Site, Neustadt, Rheinland-Pfalz, Germany
Novartis Investigative Site, Magdeburg, Sachsen Anhalt, Germany
Novartis Investigative Site, Magdeburg, Sachsen Anhalt, Germany
Novartis Investigative Site, Dresden, Sachsen, Germany
Novartis Investigative Site, Dresden, Sachsen, Germany
Novartis Investigative Site, Leipzig, Sachsen, Germany
Novartis Investigative Site, Pirna, Sachsen, Germany
Novartis Investigative Site, Rodewisch, Sachsen, Germany
Novartis Investigative Site, Scheibenberg, Sachsen, Germany
Novartis Investigative Site, Schkeuditz, Sachsen, Germany
Novartis Investigative Site, Zittau, Sachsen, Germany
Novartis Investigative Site, Zxickau, Sachsen, Germany
Novartis Investigative Site, Flensburg, Schleswig Flensburg, Germany
Novartis Investigative Site, Luebeck, Schleswig-Holstein, Germany
Novartis Investigative Site, Apolda, Thueringen, Germany
Novartis Investigative Site, Eisenach, Thueringen, Germany
Novartis Investigative Site, Erfurt, Thueringen, Germany
Novartis Investigative Site, Meinigen, Thueringen, Germany
Novartis Investigative Site, Suhl, Thueringen, Germany
Novartis Investigative Site, Altoetting, , Germany
Novartis Investigative Site, Augsburg, , Germany
Novartis Investigative Site, Augsburg, , Germany
Novartis Investigative Site, Bad Liebenwerda, , Germany
Novartis Investigative Site, Bamberg, , Germany
Novartis Investigative Site, Bayreuth, , Germany
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Bochum, , Germany
Novartis Investigative Site, Boeblingen, , Germany
Novartis Investigative Site, Bonn, , Germany
Novartis Investigative Site, Bonn, , Germany
Novartis Investigative Site, Bottrop, , Germany
Novartis Investigative Site, Brandenburg, , Germany
Novartis Investigative Site, Bremen, , Germany
Novartis Investigative Site, Bremen, , Germany
Novartis Investigative Site, Bremen, , Germany
Novartis Investigative Site, Bremerhaven, , Germany
Novartis Investigative Site, Celle, , Germany
Novartis Investigative Site, Chemnitz, , Germany
Novartis Investigative Site, Chemnitz, , Germany
Novartis Investigative Site, Cottbus, , Germany
Novartis Investigative Site, Dessau Rosslau, , Germany
Novartis Investigative Site, Dresden, , Germany
Novartis Investigative Site, Erfurt, , Germany
Novartis Investigative Site, Erlangen, , Germany
Novartis Investigative Site, Essen, , Germany
Novartis Investigative Site, Esslingen, , Germany
Novartis Investigative Site, Eutin, , Germany
Novartis Investigative Site, Frankfurt, , Germany
Novartis Investigative Site, Frankfurt, , Germany
Novartis Investigative Site, Frankfurt, , Germany
Novartis Investigative Site, Freiburg, , Germany
Novartis Investigative Site, Friedberg, , Germany
Novartis Investigative Site, Friedrichshafen, , Germany
Novartis Investigative Site, Gera, , Germany
Novartis Investigative Site, Goch, , Germany
Novartis Investigative Site, Goettingen, , Germany
Novartis Investigative Site, Goettingen, , Germany
Novartis Investigative Site, Goslar, , Germany
Novartis Investigative Site, Greifswald, , Germany
Novartis Investigative Site, Gummersbach, , Germany
Novartis Investigative Site, Halberstadt, , Germany
Novartis Investigative Site, Halle, , Germany
Novartis Investigative Site, Hamburg, , Germany
Novartis Investigative Site, Hamburg, , Germany
Novartis Investigative Site, Hamburg, , Germany
Novartis Investigative Site, Hamburg, , Germany
Novartis Investigative Site, Hamburg, , Germany
Novartis Investigative Site, Hamburg, , Germany
Novartis Investigative Site, Hameln, , Germany
Novartis Investigative Site, Hanau, , Germany
Novartis Investigative Site, Hannover, , Germany
Novartis Investigative Site, Hannover, , Germany
Novartis Investigative Site, Hannover, , Germany
Novartis Investigative Site, Hildesheim, , Germany
Novartis Investigative Site, Hof, , Germany
Novartis Investigative Site, Homburg, , Germany
Novartis Investigative Site, Ilsede, , Germany
Novartis Investigative Site, Jena, , Germany
Novartis Investigative Site, Kaiserslautern, , Germany
Novartis Investigative Site, Karlsruhe, , Germany
Novartis Investigative Site, Karlsruhe, , Germany
Novartis Investigative Site, Kassel, , Germany
Novartis Investigative Site, Kempten, , Germany
Novartis Investigative Site, Kiel, , Germany
Novartis Investigative Site, Koblenz, , Germany
Novartis Investigative Site, Koeln, , Germany
Novartis Investigative Site, Koeln, , Germany
Novartis Investigative Site, Koeln, , Germany
Novartis Investigative Site, Koeln, , Germany
Novartis Investigative Site, Kronach, , Germany
Novartis Investigative Site, Krumbach, , Germany
Novartis Investigative Site, Kulmbach, , Germany
Novartis Investigative Site, Lebach, , Germany
Novartis Investigative Site, Leipzig, , Germany
Novartis Investigative Site, Leipzig, , Germany
Novartis Investigative Site, Loerrach, , Germany
Novartis Investigative Site, Lohsa/Weißkollm, , Germany
Novartis Investigative Site, Luebeck, , Germany
Novartis Investigative Site, Mainz, , Germany
Novartis Investigative Site, Mannheim, , Germany
Novartis Investigative Site, Mannheim, , Germany
Novartis Investigative Site, Marburg, , Germany
Novartis Investigative Site, Marktredwitz, , Germany
Novartis Investigative Site, Memmingen, , Germany
Novartis Investigative Site, Minden, , Germany
Novartis Investigative Site, Moenchengladbach, , Germany
Novartis Investigative Site, Moers, , Germany
Novartis Investigative Site, Muehlhausen, , Germany
Novartis Investigative Site, Muenster, , Germany
Novartis Investigative Site, Naunhof, , Germany
Novartis Investigative Site, Neuruppin, , Germany
Novartis Investigative Site, Neuss, , Germany
Novartis Investigative Site, Neustadt/Sachsen, , Germany
Novartis Investigative Site, Nordhausen, , Germany
Novartis Investigative Site, Nuernberg, , Germany
Novartis Investigative Site, Nuernberg, , Germany
Novartis Investigative Site, Offenbach, , Germany
Novartis Investigative Site, Offenburg, , Germany
Novartis Investigative Site, Oldenburg, , Germany
Novartis Investigative Site, Osnabrueck, , Germany
Novartis Investigative Site, Passau, , Germany
Novartis Investigative Site, Pforzheim, , Germany
Novartis Investigative Site, Plauen-Kauschwitz, , Germany
Novartis Investigative Site, Potsdam, , Germany
Novartis Investigative Site, Ravensburg, , Germany
Novartis Investigative Site, Regensburg, , Germany
Novartis Investigative Site, Rheine, , Germany
Novartis Investigative Site, Rodgau, , Germany
Novartis Investigative Site, Rostock, , Germany
Novartis Investigative Site, Rostock, , Germany
Novartis Investigative Site, Rotenburg, , Germany
Novartis Investigative Site, Ruesselsheim, , Germany
Novartis Investigative Site, Saarbruecken, , Germany
Novartis Investigative Site, Saarlouis, , Germany
Novartis Investigative Site, Salzgitter, , Germany
Novartis Investigative Site, Schorndorf, , Germany
Novartis Investigative Site, Schweinfurt, , Germany
Novartis Investigative Site, Schwerte, , Germany
Novartis Investigative Site, Schwäbisch-Hall, , Germany
Novartis Investigative Site, Soest, , Germany
Novartis Investigative Site, Stade, , Germany
Novartis Investigative Site, Stendal, , Germany
Novartis Investigative Site, Stolberg, , Germany
Novartis Investigative Site, Stuttgart, , Germany
Novartis Investigative Site, Stuttgart, , Germany
Novartis Investigative Site, Suhl, , Germany
Novartis Investigative Site, Torgau, , Germany
Novartis Investigative Site, Trier, , Germany
Novartis Investigative Site, Tuebingen, , Germany
Novartis Investigative Site, Ulm, , Germany
Novartis Investigative Site, Ulm, , Germany
Novartis Investigative Site, Vechta, , Germany
Novartis Investigative Site, Voelklingen, , Germany
Novartis Investigative Site, Weiden, , Germany
Novartis Investigative Site, Weinheim, , Germany
Novartis Investigative Site, Wetzlar, , Germany
Novartis Investigative Site, Wiesbaden, , Germany
Novartis Investigative Site, Wiesbaden, , Germany
Novartis Investigative Site, Wilhelmshaven, , Germany
Novartis Investigative Site, Wolfsburg, , Germany
Novartis Investigative Site, Worms, , Germany
Novartis Investigative Site, Wuerselen, , Germany
Novartis Investigative Site, Wuerzburg, , Germany
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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