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Brief Title: A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Breast Cancer Progressing After First-Line Therapy With Avastin and Chemotherapy (TANIA)
Official Title: A Phase III Randomized Study Evaluating the Efficacy and Safety of Continued and Re-induced Bevacizumab in Combination With Chemotherapy for Patients With Locally Recurrent or Metastatic Breast Cancer After First-line Chemotherapy and Bevacizumab Treatment
Study ID: NCT01250379
Brief Summary: This randomized, open-label, parallel-group study will assess the efficacy and s afety of Avastin (bevacizumab) in combination with chemotherapy versus chemother apy alone as second- and third-line therapy in patients with locally recurrent o r metastatic breast cancer progressing after first-line therapy with Avastin and chemotherapy. Patients will be randomized to receive either Avastin (15 mg/kg e very 3 weeks or 10 mg/kg every 2 weeks intravenously) plus standard chemotherapy or chemotherapy alone. Anticipated time on study treatment is until third-line disease progression or unacceptable toxicity occurs.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
, Buenos Aires, , Argentina
, Buenos Aires, , Argentina
, Buenos Aires, , Argentina
, San Miguel de Tucuman, , Argentina
, Feldkirch, , Austria
, Graz, , Austria
, Innsbruck, , Austria
, Krems, , Austria
, Salzburg, , Austria
, Steyr, , Austria
, Villach, , Austria
, Wien, , Austria
, Goiania, GO, Brazil
, Porto Alegre, RS, Brazil
, Itajai, SC, Brazil
, Split, , Croatia
, Amiens, , France
, Angers, , France
, Besancon, , France
, Bordeaux, , France
, Boulogne Sur Mer, , France
, Brest, , France
, Caen, , France
, Clermont Ferrand, , France
, Dijon, , France
, Grenoble, , France
, Limoges, , France
, Marseille, , France
, Montpellier, , France
, Nancy, , France
, Nantes, , France
, Paris, , France
, Pierre Benite, , France
, Reims CEDEX, , France
, Rouen, , France
, Saint Gregoire, , France
, Saint Jean, , France
, St Cloud, , France
, St Priest En Jarez, , France
, St Quentin, , France
, Strasbourg, , France
, Toulouse, , France
, Amberg, , Germany
, Aschaffenburg, , Germany
, Berlin, , Germany
, Berlin, , Germany
, Bielefeld, , Germany
, Chemnitz, , Germany
, Dresden, , Germany
, Düsseldorf, , Germany
, Essen, , Germany
, Essen, , Germany
, Freiburg, , Germany
, Göttingen, , Germany
, Hamburg, , Germany
, Hannover, , Germany
, Heidelberg, , Germany
, Heidelberg, , Germany
, Karlsruhe, , Germany
, Koeln, , Germany
, Mannheim, , Germany
, Muenster, , Germany
, München, , Germany
, Naunhof, , Germany
, Neuss, , Germany
, Nordhausen, , Germany
, Osnabrueck, , Germany
, Ravensburg, , Germany
, Stade, , Germany
, Stralsund, , Germany
, Wiesbaden, , Germany
, Athens, , Greece
, Ioannina, , Greece
, Patras, , Greece
, Thessaloniki, , Greece
, Budapest, , Hungary
, Budapest, , Hungary
, Szeged, , Hungary
, Beer Sheva, , Israel
, Jerusalem, , Israel
, Kfar-Saba, , Israel
, Petach Tikva, , Israel
, Ramat Gan, , Israel
, Rehovot, , Israel
, Tel Aviv, , Israel
, Tel Aviv, , Israel
, Cosenza, Calabria, Italy
, Benevento, Campania, Italy
, Napoli, Campania, Italy
, Reggio Emilia, Emilia-Romagna, Italy
, Udine, Friuli-Venezia Giulia, Italy
, Roma, Lazio, Italy
, Monza, Lombardia, Italy
, Macerata, Marche, Italy
, Cagliari, Sardegna, Italy
, Sassari, Sardegna, Italy
, Catania, Sicilia, Italy
, Firenze, Toscana, Italy
, Pisa, Toscana, Italy
, Pontedera, Toscana, Italy
, Verona, Veneto, Italy
, Bardejov, , Slovakia
, Bratislava, , Slovakia
, Kosice, , Slovakia
, Nove Zamky, , Slovakia
, Presov, , Slovakia
, Santander, Cantabria, Spain
, San Sebastian, Guipuzcoa, Spain
, Palma De Mallorca, Islas Baleares, Spain
, La Laguna, Tenerife, Spain
, Barcelona, , Spain
, Barcelona, , Spain
, Barcelona, , Spain
, Castellon, , Spain
, Cordoba, , Spain
, Leon, , Spain
, Lerida, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Malaga, , Spain
, Murcia, , Spain
, Sevilla, , Spain
, Valencia, , Spain
, Zaragoza, , Spain
, Aarau, , Switzerland
, Chur, , Switzerland
, Zürich, , Switzerland
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR