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: October 15, 2014
Last verified: October 2014

November 25, 2010
October 15, 2014
February 2011
May 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01250379 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Chemotherapy
    Standard chemotherapy (doublets not allowed)
  • Drug: bevacizumab [Avastin]
    10 mg/ kg iv every 2 weeks or 15 mg/kg iv every 3 weeks
  • Active Comparator: 1
    Intervention: Drug: Chemotherapy
  • Experimental: 2
    Interventions:
    • Drug: Chemotherapy
    • Drug: bevacizumab [Avastin]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
494
May 2015
May 2015   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel,   Argentina,   Austria,   Brazil,   Croatia,   France,   Germany,   Greece,   Hungary,   Switzerland,   Italy,   Slovakia,   Spain
 
NCT01250379
MO22998, 2010-020998-16
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP