A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Breast Cancer Progressing After First-Line Therapy With Avastin and Chemotherapy (TANIA)
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
2 other identifiers
interventional
494
13 countries
132
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Feb 2011
132 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2010
CompletedFirst Posted
Study publicly available on registry
November 30, 2010
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
June 30, 2015
CompletedFebruary 11, 2016
January 1, 2016
2.8 years
November 25, 2010
June 5, 2015
January 12, 2016
Conditions
Outcome Measures
Primary Outcomes (6)
Percentage of Participants With Second-Line Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)
Second-line PFS was defined as the time from randomization to progressive disease (PD) or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Baseline (less than or equal to [≤] 28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
Second-Line PFS
The median time, in months, from randomization to second-line PFS event. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 6
Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Month 6
Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 12
Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without secondline PD or death were censored at the date of last tumor assessment where non-progression was documented.
Month 12
Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 18
Second-line PFS was defined as the time from randomization to PD or death due to any cause during their secondline of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Month 18
Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 24
Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Month 24
Secondary Outcomes (21)
Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)
Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
Percentage of Participants With a Second-Line Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 (Data Cutoff 20 December 2013)
Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
Percentage of Participants With a Second-Line CR, PR, Stable Disease, and PD According to RECIST v1.1 (Data Cutoff 20 December 2013)
Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
Duration of Second-Line Objective Response (Data Cutoff 20 December 2013)
Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
Percentage of Participants With a Second-Line Documented CR or PR According to RECIST v1.1 Estimated to be Alive and Free of Disease Progression at Months 3, 6, and 9 (Data Cutoff 20 December 2013)
Months 3, 6, and 9
- +16 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATOR2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Female patients, \>/= 18 years of age
- 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
You may not qualify if:
- Anti-angiogenic therapy or anti-vascular endothelial growth factors other than Avastin for first-line treatment
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (132)
Unknown Facility
Buenos Aires, C1199ACI, Argentina
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Buenos Aires, C1280AEB, Argentina
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Buenos Aires, C1426ANZ, Argentina
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San Miguel de Tucumán, T4000IAK, Argentina
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Feldkirch, 6807, Austria
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Krems, 3500, Austria
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Salzburg, 5020, Austria
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Steyr, 4400, Austria
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Vienna, 1090, Austria
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Villach, 9500, Austria
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Goiânia, Goiás, 74140-050, Brazil
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Porto Alegre, Rio Grande do Sul, 90430-090, Brazil
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Itajaí, Santa Catarina, 88301-220, Brazil
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Split, 21000, Croatia
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Amiens, 80090, France
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Angers, 49933, France
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Besançon, 25030, France
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Bordeaux, 33000, France
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Boulogne-sur-Mer, 62222, France
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Brest, 29609, France
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Caen, 14076, France
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Clermont-Ferrand, 63011, France
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Dijon, 21079, France
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Grenoble, 38028, France
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Limoges, 87039, France
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Marseille, 13285, France
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Montpellier, 34298, France
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Nancy, 54100, France
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Nantes, 44202, France
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Paris, 75970, France
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Pierre-Bénite, 69495, France
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Reims, 51056, France
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Rouen, 76038, France
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Saint-Cloud, 92210, France
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Saint-Grégoire, 35768, France
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Saint-Jean, 31240, France
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Saint-Priest-en-Jarez, 42271, France
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Saint-Quentin, 02321, France
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Strasbourg, 67010, France
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Toulouse, 31076, France
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Amberg, 92224, Germany
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Aschaffenburg, 63739, Germany
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Berlin, 10367, Germany
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Berlin, 10719, Germany
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Bielefeld, 33604, Germany
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Chemnitz, 09116, Germany
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Cologne, 50935, Germany
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Dresden, 01307, Germany
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Düsseldorf, 40235, Germany
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Essen, 45122, Germany
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Essen, 45136, Germany
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Freiburg im Breisgau, 79110, Germany
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Göttingen, 37073, Germany
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Hamburg, 20249, Germany
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Hanover, 30177, Germany
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Heidelberg, 69115, Germany
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Heidelberg, 69120, Germany
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Karlsruhe, 76135, Germany
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Mannheim, 68161, Germany
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München, 80639, Germany
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Münster, 48149, Germany
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Naunhof, 04683, Germany
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Neuss, 41462, Germany
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Nordhausen, 99734, Germany
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Osnabrück, 49076, Germany
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Ravensburg, 88212, Germany
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Stade, 21680, Germany
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Stralsund, 18435, Germany
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Wiesbaden, 65199, Germany
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Athens, 11528, Greece
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Ioannina, 455 00, Greece
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Pátrai, 265 00, Greece
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Thessaloniki, 546 45, Greece
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Budapest, 1122, Hungary
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Budapest, 1145, Hungary
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Szeged, 6720, Hungary
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Beersheba, 8410101, Israel
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Jerusalem, 91120, Israel
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Kfar Saba, 4428164, Israel
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Petah Tikva, 4941492, Israel
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Ramat Gan, 52620-00, Israel
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Rehovot, 7610001, Israel
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Tel Aviv, 6423906, Israel
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Tel Aviv, Israel
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Cosenza, Calabria, 87100, Italy
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Benevento, Campania, 82100, Italy
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Napoli, Campania, 80131, Italy
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Reggio Emilia, Emilia-Romagna, 42100, Italy
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Udine, Friuli Venezia Giulia, 33100, Italy
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Rome, Lazio, 00168, Italy
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Monza, Lombardy, 20052, Italy
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Cagliari, Sardinia, 09121, Italy
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Sassari, Sardinia, 07100, Italy
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Catania, Sicily, 95100, Italy
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Macerata, The Marches, 62100, Italy
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Florence, Tuscany, 50134, Italy
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Pisa, Tuscany, 56100, Italy
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Pontedera, Tuscany, 56025, Italy
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Verona, Veneto, 37126, Italy
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Bardejov, 085 01, Slovakia
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Bratislava, 812 50, Slovakia
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Košice, 04001, Slovakia
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Nové Zámky, 940 34, Slovakia
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Prešov, 080 01, Slovakia
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Palma de Mallorca, Balearic Islands, 07014, Spain
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Barcelona, Barcelona, 08035, Spain
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Barcelona, Barcelona, 08036, Spain
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Barcelona, Barcelona, 08041, Spain
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Santander, Cantabria, 39008, Spain
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Castellon, Castellon, 12002, Spain
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Córdoba, Cordoba, 14004, Spain
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Donostia / San Sebastian, Guipuzcoa, 20080, Spain
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León, Leon, 24071, Spain
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Lleida, Lerida, 25198, Spain
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Madrid, Madrid, 28007, Spain
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Madrid, Madrid, 28033, Spain
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Madrid, Madrid, 28034, Spain
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Madrid, Madrid, 28040, Spain
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Madrid, Madrid, 28041, Spain
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Madrid, Madrid, 28046, Spain
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Madrid, Madrid, 28223, Spain
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Málaga, Malaga, 29010, Spain
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Murcia, Murcia, 30008, Spain
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Seville, Sevilla, 41014, Spain
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San Cristóbal de La Laguna, Tenerife, 38320, Spain
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Valencia, Valencia, 46009, Spain
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Zaragoza, Zaragoza, 50009, Spain
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Aarau, 5000, Switzerland
Unknown Facility
Chur, 7000, Switzerland
Unknown Facility
Zurich, 8038, Switzerland
Related Publications (2)
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.
PMID: 27502725DERIVEDvon 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.
PMID: 25273342DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffman-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2010
First Posted
November 30, 2010
Study Start
February 1, 2011
Primary Completion
December 1, 2013
Study Completion
March 1, 2015
Last Updated
February 11, 2016
Results First Posted
June 30, 2015
Record last verified: 2016-01