A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Breast Cancer Progressing After First-Line Therapy With Avastin and Chemotherapy (TANIA)
NCT ID: NCT01250379
Last Updated: 2016-02-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
494 participants
INTERVENTIONAL
2011-02-28
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Chemotherapy
Standard chemotherapy (doublets not allowed)
2
bevacizumab [Avastin]
10 mg/ kg iv every 2 weeks or 15 mg/kg iv every 3 weeks
Chemotherapy
Standard chemotherapy (doublets not allowed)
Interventions
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bevacizumab [Avastin]
10 mg/ kg iv every 2 weeks or 15 mg/kg iv every 3 weeks
Chemotherapy
Standard chemotherapy (doublets not allowed)
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed HER2-negative breast cancer
* Disease progression during or following first-line treatment with Avastin and chemotherapy for locally recurrent or metastatic breast cancer
* Avastin treatment in first-line setting must have been a minimum of 4 cycles (15 mg/kg) or 6 cycles (10 mg/kg) in combination with chemotherapy
* ECOG performance status 0-2
* At least 28 days since prior radiation therapy or surgery and recovery from treatment
Exclusion Criteria
* Active malignancy other than superficial basal cell and superficial squamous cell carcinoma of the skin, or in situ carcinoma of the cervix or breast within the last 5 years
* Inadequate renal function
* Clinically relevant cardio-vascular disease
* Known CNS disease except for treated brain metastases
* Chronic daily treatment with high-dose aspirin (\>325 mg/day) or clopidogrel (\>75 mg/day)
* Pregnant or lactating women
18 Years
FEMALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
San Miguel de Tucumán, , Argentina
Feldkirch, , Austria
Graz, , Austria
Innsbruck, , Austria
Krems, , Austria
Salzburg, , Austria
Steyr, , Austria
Vienna, , Austria
Villach, , Austria
Goiânia, Goiás, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Itajaí, Santa Catarina, Brazil
Split, , Croatia
Amiens, , France
Angers, , France
Besançon, , 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-Bénite, , France
Reims, , France
Rouen, , France
Saint-Cloud, , France
Saint-Grégoire, , France
Saint-Jean, , France
Saint-Priest-en-Jarez, , France
Saint-Quentin, , France
Strasbourg, , France
Toulouse, , France
Amberg, , Germany
Aschaffenburg, , Germany
Berlin, , Germany
Berlin, , Germany
Bielefeld, , Germany
Chemnitz, , Germany
Cologne, , Germany
Dresden, , Germany
Düsseldorf, , Germany
Essen, , Germany
Essen, , Germany
Freiburg im Breisgau, , Germany
Göttingen, , Germany
Hamburg, , Germany
Hanover, , Germany
Heidelberg, , Germany
Heidelberg, , Germany
Karlsruhe, , Germany
Mannheim, , Germany
München, , Germany
Münster, , Germany
Naunhof, , Germany
Neuss, , Germany
Nordhausen, , Germany
Osnabrück, , Germany
Ravensburg, , Germany
Stade, , Germany
Stralsund, , Germany
Wiesbaden, , Germany
Athens, , Greece
Ioannina, , Greece
Pátrai, , Greece
Thessaloniki, , Greece
Budapest, , Hungary
Budapest, , Hungary
Szeged, , Hungary
Beersheba, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Petah 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
Rome, Lazio, Italy
Monza, Lombardy, Italy
Cagliari, Sardinia, Italy
Sassari, Sardinia, Italy
Catania, Sicily, Italy
Macerata, The Marches, Italy
Florence, Tuscany, Italy
Pisa, Tuscany, Italy
Pontedera, Tuscany, Italy
Verona, Veneto, Italy
Bardejov, , Slovakia
Bratislava, , Slovakia
Košice, , Slovakia
Nové Zámky, , Slovakia
Prešov, , Slovakia
Palma de Mallorca, Balearic Islands, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Santander, Cantabria, Spain
Castellon, Castellon, Spain
Córdoba, Cordoba, Spain
Donostia / San Sebastian, Guipuzcoa, Spain
León, Leon, Spain
Lleida, Lerida, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Málaga, Malaga, Spain
Murcia, Murcia, Spain
Seville, Sevilla, Spain
San Cristóbal de La Laguna, Tenerife, Spain
Valencia, Valencia, Spain
Zaragoza, Zaragoza, Spain
Aarau, , Switzerland
Chur, , Switzerland
Zurich, , Switzerland
Countries
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References
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Vrdoljak E, Marschner N, Zielinski C, Gligorov J, Cortes J, Puglisi F, Aapro M, Fallowfield L, Fontana A, Inbar M, Kahan Z, Welt A, Levy C, Brain E, Pivot X, Putzu C, Gonzalez Martin A, de Ducla S, Easton V, von Minckwitz G. Final results of the TANIA randomised phase III trial of bevacizumab after progression on first-line bevacizumab therapy for HER2-negative locally recurrent/metastatic breast cancer. Ann Oncol. 2016 Nov;27(11):2046-2052. doi: 10.1093/annonc/mdw316. Epub 2016 Aug 8.
von Minckwitz G, Puglisi F, Cortes J, Vrdoljak E, Marschner N, Zielinski C, Villanueva C, Romieu G, Lang I, Ciruelos E, De Laurentiis M, Veyret C, de Ducla S, Freudensprung U, Srock S, Gligorov J. Bevacizumab plus chemotherapy versus chemotherapy alone as second-line treatment for patients with HER2-negative locally recurrent or metastatic breast cancer after first-line treatment with bevacizumab plus chemotherapy (TANIA): an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1269-78. doi: 10.1016/S1470-2045(14)70439-5. Epub 2014 Sep 28.
Other Identifiers
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2010-020998-16
Identifier Type: -
Identifier Source: secondary_id
MO22998
Identifier Type: -
Identifier Source: org_study_id
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