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

Tracking Information

Start Date  ICMJESeptember 2006
Primary Completion Date 
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2008)
Progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJE 
 (submitted: October 20, 2006)
Progression-free survival
Change HistoryComplete list of historical versions of study NCT00391092 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: January 18, 2008)
  • Overall survival [ Time Frame: (36 months after randomization of last patient) ] [ Designated as safety issue: No ]
  • Best overall response, duration of response, time to treatment failure. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • QoL, AEs, targeted events including CHF, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJE 
 (submitted: October 20, 2006)
Efficacy: Overall survival, best overall response, duration of response, time to treatment failure, quality of life. Safety: AEs, targeted events including CHF, laboratory parameters.

Descriptive Information

Brief Title  ICMJEA Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab)/Docetaxel in Patients With HER2 Positive Metastatic Breast Cancer.
Official Title  ICMJEA Randomized, Open-label Study to Compare the Effect of First-line Treatment With Avastin in Combination With Herceptin/Docetaxel and Herceptin/Docetaxel Alone on Progression-free Survival in Patients With HER2 Positive Locally Recurrent or Metastatic Breast Cancer.
Brief 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.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEBreast Cancer
Intervention  ICMJE
  • Drug: bevacizumab [Avastin]
    15mg/kg iv every 3 weeks
  • Drug: Herceptin
    8mg/kg iv loading dose, followed by 6mg/kg iv every 3 weeks
  • Drug: Docetaxel
    100mg/m2 iv every 3 weeks
Study Arms / Comparison Groups
  • 1: Experimental
    • Drug: bevacizumab [Avastin]
    • Drug: Herceptin
    • Drug: Docetaxel
  • 2: Active Comparator
    • Drug: Herceptin
    • Drug: Docetaxel

Recruitment Information

Estimated Enrollment  ICMJE410
Estimated Completion DateDecember 2011
Primary Completion Date 
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • HER2 positive breast cancer with locally recurrent or metastatic lesions;
  • eligible for chemotherapy;
  • baseline LVEF >=50%.

Exclusion Criteria:

  • previous chemotherapy for metastatic or locally recurrent breast cancer;
  • previous radiotherapy for metastatic breast cancer (except for metastatic bone pain relief);
  • other primary tumor within last 5 years, with the exception of basal or squamous skin cancer, or in situ cancer of the cervix;
  • clinically significant cardiovascular disease;
  • chronic daily treatment with aspirin (>325mg/day) or clopidogrel (>75mg/day).
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Please reference Study ID Number: BO20231888-662-6728 (U.S. Only)genentechclinicaltrials@druginfo.com
Location Countries  ICMJEArgentina,   Australia,   Austria,   Bosnia and Herzegovina,   Brazil,   Canada,   Czech Republic,   France,   Italy,   Mexico,   Romania,   Russian Federation,   Spain,   Turkey,   United Kingdom,   Uruguay

Administrative Information

Responsible PartyDisclosures Group, Hoffmann-La Roche
Study ID Numbers  ICMJEBO20231
Study Sponsor  ICMJEHoffmann-La Roche
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Clinical TrialsHoffmann-La Roche
Information Provided ByHoffmann-La Roche