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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: November 17, 2014
Last verified: November 2014
  Purpose

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.


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: May 2015
Estimated Primary Completion Date: May 2015 (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

  Show 132 Study Locations
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: November 17, 2014
Health Authority: Argentina: Administración Nacional de Medicamentos, Alimentos y Tecnología Médica

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

ClinicalTrials.gov processed this record on November 25, 2014