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A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab)/Docetaxel in Patients With HER2 Positive Metastatic Breast Cancer.

NCT00391092 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 424

Last updated 2015-08-28

Study results available
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Summary

This 2 arm study will compare the efficacy and safety of Avastin plus Herceptin/docetaxel, versus Herceptin/docetaxel alone, in patients with HER2 positive locally recurrent or metastatic breast cancer who have not received prior chemotherapy for their metastatic disease. Patients will be randomized 1:1 to receive either Avastin (15mg/kg iv q3weeks) + Herceptin (8mg/kg iv loading dose and 6mg/kg iv q3weeks maintenance) + docetaxel (100mg/m2 iv q3weeks) or Herceptin + docetaxel alone. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Conditions

Interventions

DRUG

bevacizumab [Avastin]

15mg/kg iv every 3 weeks

DRUG

Docetaxel

100mg/m2 iv every 3 weeks

DRUG

Herceptin

8mg/kg iv loading dose, followed by 6mg/kg iv every 3 weeks

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
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • Argentina
  • Australia
  • Austria
  • Bosnia and Herzegovina
  • Brazil
  • Canada
  • Czechia
  • France
  • Italy
  • Mexico
  • Romania
  • Russia
  • Spain
  • Turkey (Türkiye)
  • United Kingdom
  • Uruguay

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 NCT00391092 on ClinicalTrials.gov