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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00333775
Registration number
NCT00333775
Ethics application status
Date submitted
5/06/2006
Date registered
6/06/2006
Date last updated
27/01/2016
Titles & IDs
Public title
A Study of Bevacizumab (Avastin) in Women With HER2 Negative Metastatic Breast Cancer
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Scientific 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.
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Secondary ID [1]
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2005-003862-40
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Secondary ID [2]
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BO17708
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Docetaxel
Treatment: Drugs - Placebo to bevacizumab
Treatment: Drugs - Bevacizumab
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.
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.
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.
Treatment: Drugs: Docetaxel
Docetaxel was supplied in 2 vials, 1 containing docetaxel and 1 containing a solvent, for intravenous infusion.
Treatment: Drugs: Placebo to bevacizumab
Placebo to bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.
Treatment: Drugs: Bevacizumab
Bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival
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Assessment method [1]
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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).
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Timepoint [1]
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Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)
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Secondary outcome [1]
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Percentage of Participants With a Complete Response or a Partial Response
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)
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Secondary outcome [2]
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Duration of Response
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months)
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Secondary outcome [3]
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Time to Treatment Failure
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months)
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Secondary outcome [4]
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Overall Survival
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Assessment method [4]
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Overall survival was defined as the time from randomization to death from any cause.
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Timepoint [4]
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Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)
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Eligibility
Key inclusion 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2013
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Sample size
Target
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Accrual to date
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Final
736
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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- Adelaide
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- Camperdown
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- Westmead
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- Auchenflower
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- Box Hill
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- Fitzroy
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- Ringwood East
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- Perth
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5011 - Adelaide
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2050 - Camperdown
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2145 - Westmead
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4066 - Auchenflower
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3128 - Box Hill
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3065 - Fitzroy
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3135 - Ringwood East
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Recruitment postcode(s) [8]
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6000 - Perth
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Austria
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Graz
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Austria
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Wilrijk
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GO
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Truro
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00333775
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Clinical Trials
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Hoffmann-La Roche
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00333775
Download to PDF