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A Study of Bevacizumab (Avastin) 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: December 21, 2015
Last verified: December 2015

June 5, 2006
December 21, 2015
March 2006
October 2007   (final data collection date for primary outcome measure)
Progression-free Survival [ Time Frame: Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months) ] [ Designated as safety issue: No ]
Progression-free survival was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST 1.0). Progression-free survival was defined as the time from randomization to the time of the first documented disease progression or death, whichever occurred first. Disease progression was defined as ≥ 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions, or appearance of new lesion(s).
Progression-free Survival
Complete list of historical versions of study NCT00333775 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With a Complete Response or a Partial Response [ Time Frame: Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months) ] [ Designated as safety issue: No ]
    Responses were evaluated using the Response Evaluation Criteria in Solid Tumors. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.
  • Duration of Response [ Time Frame: Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months) ] [ Designated as safety issue: No ]
    Duration of response was defined as the time from the first documented complete response or partial response to disease progression or death. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Responses were evaluated using the Response Evaluation Criteria in Solid Tumors.
  • Time to Treatment Failure [ Time Frame: Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months) ] [ Designated as safety issue: No ]
    Time to treatment failure was defined as time from randomization to the date of disease progression, death, or withdrawal of treatment due to an adverse event, withdrawal of informed consent, insufficient therapeutic response, refusal of treatment/failure to co-operate, or failure to return, whichever occurred first.
  • Overall Survival [ Time Frame: Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months) ] [ Designated as safety issue: No ]
    Overall survival was defined as the time from randomization to death from any cause.
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
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A Study of Bevacizumab (Avastin) 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 combination with docetaxel, versus docetaxel plus placebo, in patients with metastatic HER2 negative breast cancer who are candidates for taxane-based chemotherapy but who have not received prior chemotherapy for metastatic disease. The anticipated time on treatment is 1-2 years and the target sample size is 500+ individuals.
Five participants randomized to the docetaxel 100 mg/m^2 plus placebo group actually received docetaxel 100 mg/m^2 plus bevacizumab 7.5 mg/kg and are included in the docetaxel 100 mg/m^2 plus bevacizumab 7.5 mg/kg group for the adverse event results. Sixteen participants randomized to the docetaxel 100 mg/m^2 plus placebo group actually received docetaxel 100 mg/m^2 plus bevacizumab 15.0 mg/kg and are included in the docetaxel 100 mg/m^2 plus bevacizumab 15.0 mg/kg group for the adverse event results.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Breast Cancer
  • Drug: Docetaxel
    Docetaxel was supplied in 2 vials, 1 containing docetaxel and 1 containing a solvent, for intravenous infusion.
  • Drug: Placebo to bevacizumab
    Placebo to bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.
  • Drug: Bevacizumab
    Bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.
    Other Name: Avastin
  • Experimental: Docetaxel 100 mg/m^2 plus placebo
    Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
    Interventions:
    • Drug: Docetaxel
    • Drug: Placebo to bevacizumab
  • Experimental: Docetaxel 100 mg/m^2 plus bevacizumab 7.5 mg/kg
    Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
    Interventions:
    • Drug: Docetaxel
    • Drug: Bevacizumab
  • Experimental: Docetaxel 100 mg/m^2 plus bevacizumab 15.0 mg/kg
    Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
    Interventions:
    • Drug: Docetaxel
    • Drug: Bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
736
October 2013
October 2007   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Female patients ≥ 18 years of age.
  • Human epidermal growth factor receptor 2 (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.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 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   (Adult, Senior)
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
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Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
December 2015

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