A Study of Avastin (Bevacizumab) in Women With HER2 Negative Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00333775
First received: June 5, 2006
Last updated: July 7, 2014
Last verified: July 2014

June 5, 2006
July 7, 2014
March 2006
October 2013   (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 NCT00333775 on ClinicalTrials.gov Archive Site
  • Best overall response, duration of response, time to treatment failure, overall survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, FACT-B, QoL instrument, medical resource utilization [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Efficacy: Best overall response; duration of response; time to treatment failure, overall survival. Safety: Adverse events, laboratory parameters. Quality of Life: FACT-B QoL instrument, medical resource utilization
Not Provided
Not Provided
 
A Study of Avastin (Bevacizumab) in Women With HER2 Negative Metastatic Breast Cancer
A Randomised, Double Blind, Placebo Controlled, Multicentre Study to Evaluate the Efficacy and Safety of Bevacizumab in Combination With Docetaxel in Comparison With Docetaxel Plus Placebo, as First Line Treatment for Patients With HER2 Negative Metastatic and Locally Recurrent Breast Cancer.

This study will evaluate the efficacy and safety of 2 doses of Avastin in combin ation with docetaxel, versus docetaxel plus placebo, in patients with metastatic HER2 negative breast cancer who are candidates for taxane-based chemotherapy bu t who have not received prior chemotherapy for metastatic disease. The anticipat ed time on treatment is 1-2 years and the target sample size is 500+ individuals

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Breast Cancer
  • Drug: bevacizumab [Avastin]
    7.5 mg/kg iv on day 1 of eah 3 week cycle
  • Drug: bevacizumab [Avastin]
    15mg/kg iv on day 1 of each 3 week cycle
  • Drug: Placebo
    iv on day 1 of each 3 week cycle
  • Drug: Docetaxel
    100mg/m2 iv on day 1 of each 3 week cycle
  • Experimental: 1
    Interventions:
    • Drug: bevacizumab [Avastin]
    • Drug: Docetaxel
  • Experimental: 2
    Interventions:
    • Drug: bevacizumab [Avastin]
    • Drug: Docetaxel
  • Placebo Comparator: 3
    Interventions:
    • Drug: Placebo
    • Drug: Docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
735
October 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • female patients >= 18 years of age;
  • HER2 negative cancer of the breast with locally recurrent or metastatic disease, suitable for chemotherapy;
  • no adjuvant chemotherapy within 6 months before randomization, and no taxane-based chemotherapy within 12 months before randomization;
  • ECOG performance status 0-1.

Exclusion Criteria:

  • previous chemotherapy for metastatic or locally recurrent breast cancer;
  • radiotherapy for treatment of metastatic disease;
  • other primary tumors within last 5 years, except for controlled limited basal cell or squamous cancer of the skin, or cancer in situ of the cervix;
  • spinal cord compression or brain metastases;
  • major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization;
  • inadequate bone marrow, liver or renal function;
  • uncontrolled hypertension.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Brazil,   Canada,   China,   France,   Germany,   Italy,   Korea, Republic of,   Lithuania,   Mexico,   Netherlands,   Panama,   Poland,   Portugal,   Romania,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Thailand,   United Kingdom
 
NCT00333775
BO17708, 2005-003862-40
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2014

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