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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00391092
First received: October 20, 2006
Last updated: June 23, 2014
Last verified: June 2014

October 20, 2006
June 23, 2014
September 2006
June 2014   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Progression-free survival
Complete list of historical versions of study NCT00391092 on ClinicalTrials.gov Archive Site
  • 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 ]
Efficacy: Overall survival, best overall response, duration of response, time to treatment failure, quality of life. Safety: AEs, targeted events including CHF, laboratory parameters.
Not Provided
Not Provided
 
A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab)/Docetaxel in Patients With HER2 Positive Metastatic Breast Cancer.
A 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.

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

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: 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
  • Active Comparator: 2
    Interventions:
    • Drug: Herceptin
    • Drug: Docetaxel
  • Experimental: 1
    Interventions:
    • Drug: bevacizumab [Avastin]
    • Drug: Herceptin
    • Drug: Docetaxel
Gianni L, Romieu GH, Lichinitser M, Serrano SV, Mansutti M, Pivot X, Mariani P, Andre F, Chan A, Lipatov O, Chan S, Wardley A, Greil R, Moore N, Prot S, Pallaud C, Semiglazov V. AVEREL: a randomized phase III Trial evaluating bevacizumab in combination with docetaxel and trastuzumab as first-line therapy for HER2-positive locally recurrent/metastatic breast cancer. J Clin Oncol. 2013 May 10;31(14):1719-25. doi: 10.1200/JCO.2012.44.7912. Epub 2013 Apr 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
424
June 2014
June 2014   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Austria,   Bosnia and Herzegovina,   Brazil,   Canada,   Czech Republic,   France,   Italy,   Mexico,   Romania,   Russian Federation,   Spain,   Turkey,   United Kingdom,   Uruguay
 
NCT00391092
BO20231
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
June 2014

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