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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00333775
Recruitment Status : Completed
First Posted : June 6, 2006
Results First Posted : January 27, 2016
Last Update Posted : January 27, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Docetaxel Drug: Placebo to bevacizumab Drug: Bevacizumab Phase 3

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 736 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : March 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
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.
 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.
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.
 Drug: Docetaxel
Docetaxel was supplied in 2 vials, 1 containing docetaxel and 1 containing a solvent, for intravenous infusion.

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 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.
 Drug: Docetaxel
Docetaxel was supplied in 2 vials, 1 containing docetaxel and 1 containing a solvent, for intravenous infusion.

Drug: Bevacizumab
Bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.
Other Name: Avastin


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free Survival [ Time Frame: Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months) ]
    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).


Secondary Outcome Measures :
  1. 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) ]
    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.

  2. Duration of Response [ Time Frame: Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months) ]
    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.

  3. Time to Treatment Failure [ Time Frame: Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months) ]
    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.

  4. Overall Survival [ Time Frame: Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months) ]
    Overall survival was defined as the time from randomization to death from any cause.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333775


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00333775    
Other Study ID Numbers: BO17708
2005-003862-40 ( EudraCT Number )
First Posted: June 6, 2006    Key Record Dates
Results First Posted: January 27, 2016
Last Update Posted: January 27, 2016
Last Verified: December 2015
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bevacizumab
Docetaxel
Antineoplastic Agents, Immunological
Antineoplastic Agents
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action