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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)

NCT01250379 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 494

Last updated 2016-02-11

Study results available
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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.

Conditions

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-12-31
Completion
2015-03-31

Countries

  • Argentina
  • Austria
  • Brazil
  • Croatia
  • France
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Slovakia
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01250379 on ClinicalTrials.gov