A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Breast Cancer Progressing After First-Line Therapy With Avastin and Chemotherapy (TANIA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01250379
First received: November 25, 2010
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

This randomized, open-label, parallel-group study will assess the efficacy and safety of Avastin (bevacizumab) in combination with chemotherapy versus chemotherapy alone as second- and third-line therapy in patients with locally recurrent or metastatic breast cancer progressing after first-line therapy with Avastin and chemotherapy. Patients will be randomized to receive either Avastin (15 mg/kg every 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.


Condition Intervention Phase
Breast Cancer
Drug: bevacizumab [Avastin]
Drug: Chemotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Second-line progression-free survival (PFS), tumour assessments according to RECIST criteria by Computed Tomography (CT)/Magnetic Resonance Imaging (MRI)/bone scans and X-ray [ Time Frame: approximately 42 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Third-line PFS, tumour assessments according to RECIST criteria by CT/MRI/bone scan and X-ray [ Time Frame: approximately 42 months ] [ Designated as safety issue: No ]
  • Second-line Overall Response Rate (ORR), tumour assessments according to RECIST criteria by CT/MRI/bone scan and x-ray [ Time Frame: approximately 42 months ] [ Designated as safety issue: No ]
  • One-year survival [ Time Frame: approximately 42 months ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: approximately 42 months ] [ Designated as safety issue: No ]
  • Quality of life: Functional assessment of cancer therapy - breast (FACT-B) scale, EuroQuol (EQ-5D) questionnaire [ Time Frame: approximately 42 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 42 months ] [ Designated as safety issue: No ]

Enrollment: 494
Study Start Date: February 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Chemotherapy
Standard chemotherapy (doublets not allowed)
Experimental: 2 Drug: bevacizumab [Avastin]
10 mg/ kg iv every 2 weeks or 15 mg/kg iv every 3 weeks
Drug: Chemotherapy
Standard chemotherapy (doublets not allowed)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01250379

  Hide Study Locations
Locations
Argentina
Buenos Aires, Argentina, C1426ANZ
Buenos Aires, Argentina, C1199ACI
Buenos Aires, Argentina, C1280AEB
San Miguel de Tucuman, Argentina, T4000IAK
Austria
Feldkirch, Austria, 6807
Graz, Austria, 8036
Innsbruck, Austria, 6020
Krems, Austria, 3500
Salzburg, Austria, 5020
Steyr, Austria, 4400
Villach, Austria, 9500
Wien, Austria, 1090
Brazil
Goiania, GO, Brazil, 74140-050
Porto Alegre, RS, Brazil, 90430-090
Itajai, SC, Brazil, 88301-220
Croatia
Split, Croatia, 21000
France
Amiens, France, 80090
Angers, France, 49933
Besancon, France, 25030
Bordeaux, France, 33000
Boulogne Sur Mer, France, 62222
Brest, France, 29609
Caen, France, 14076
Clermont Ferrand, France, 63011
Dijon, France, 21079
Grenoble, France, 38028
Limoges, France, 87039
Marseille, France, 13285
Montpellier, France, 34298
Nancy, France, 54100
Nantes, France, 44202
Paris, France, 75970
Pierre Benite, France, 69495
Reims CEDEX, France, 51056
Rouen, France, 76038
Saint Gregoire, France, 35768
Saint Jean, France, 31240
St Cloud, France, 92210
St Priest En Jarez, France, 42271
St Quentin, France, 02321
Strasbourg, France, 67010
Toulouse, France, 31076
Germany
Amberg, Germany, 92224
Aschaffenburg, Germany, 63739
Berlin, Germany, 10719
Berlin, Germany, 10367
Bielefeld, Germany, 33604
Chemnitz, Germany, 09116
Dresden, Germany, 01307
Düsseldorf, Germany, 40235
Essen, Germany, 45136
Essen, Germany, 45122
Freiburg, Germany, 79110
Göttingen, Germany, 37073
Hamburg, Germany, 20249
Hannover, Germany, 30177
Heidelberg, Germany, 69120
Heidelberg, Germany, 69115
Karlsruhe, Germany, 76135
Koeln, Germany, 50935
Mannheim, Germany, 68161
Muenster, Germany, 48149
München, Germany, 80639
Naunhof, Germany, 04683
Neuss, Germany, 41462
Nordhausen, Germany, 99734
Osnabrueck, Germany, 49076
Ravensburg, Germany, 88212
Stade, Germany, 21680
Stralsund, Germany, 18435
Wiesbaden, Germany, 65199
Greece
Athens, Greece, 11528
Ioannina, Greece, 455 00
Patras, Greece, 265 00
Thessaloniki, Greece, 54645
Hungary
Budapest, Hungary, 1122
Budapest, Hungary, 1145
Szeged, Hungary, 6701
Israel
Beer Sheva, Israel, 8410101
Jerusalem, Israel, 91120
Kfar-Saba, Israel, 4428164
Petach Tikva, Israel, 4941492
Ramat-Gan, Israel, 52621
Rehovot, Israel, 7610001
Tel Aviv, Israel, 6423906
Tel Aviv, Israel
Italy
Cosenza, Calabria, Italy, 87100
Benevento, Campania, Italy, 82100
Napoli, Campania, Italy, 80131
Reggio Emilia, Emilia-Romagna, Italy, 42100
Udine, Friuli-Venezia Giulia, Italy, 33100
Roma, Lazio, Italy, 00168
Monza, Lombardia, Italy, 20052
Macerata, Marche, Italy, 62100
Cagliari, Sardegna, Italy, 09121
Sassari, Sardegna, Italy, 07100
Catania, Sicilia, Italy, 95100
Firenze, Toscana, Italy, 50134
Pisa, Toscana, Italy, 56100
Pontedera, Toscana, Italy, 56025
Verona, Veneto, Italy, 37126
Slovakia
Bardejov, Slovakia, 085 01
Bratislava, Slovakia, 812 50
Kosice, Slovakia, 04001
Nove Zamky, Slovakia, 940 34
Presov, Slovakia, 080 01
Spain
Santander, Cantabria, Spain, 39008
San Sebastian, Guipuzcoa, Spain, 20080
Palma De Mallorca, Islas Baleares, Spain, 07014
La Laguna, Tenerife, Spain, 38320
Barcelona, Spain, 08041
Barcelona, Spain, 08036
Barcelona, Spain, 08035
Castellon, Spain, 12002
Cordoba, Spain, 14004
Leon, Spain, 24071
Lerida, Spain, 25198
Madrid, Spain, 28034
Madrid, Spain, 28041
Madrid, Spain, 28046
Madrid, Spain, 28033
Madrid, Spain, 28040
Madrid, Spain, 28223
Malaga, Spain, 29010
Murcia, Spain, 30008
Sevilla, Spain, 41014
Valencia, Spain, 46009
Zaragoza, Spain, 50009
Switzerland
Aarau, Switzerland, 5000
Chur, Switzerland, 7000
Zürich, Switzerland, 8038
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01250379     History of Changes
Other Study ID Numbers: MO22998, 2010-020998-16
Study First Received: November 25, 2010
Last Updated: January 6, 2014
Health Authority: Argentina: Administración Nacional de Medicamentos, Alimentos y Tecnología Médica

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014