A Study of Bevacizumab With Taxane Therapy in Participants With Triple Negative Breast Cancer
NCT ID: NCT01094184
Last Updated: 2018-03-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
49 participants
INTERVENTIONAL
2010-03-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bevacizumab 10 mg/kg Q2W
Participants will receive bevacizumab at a dose of 10 milligrams per kilogram (mg/kg) every 2 weeks (Q2W) as intravenous infusion along with paclitaxel every week (Q1W) or docetaxel every 3 weeks (Q3W) as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
Bevacizumab
Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion.
Paclitaxel
Paclitaxel will be administered as intravenous infusion Q1W as per discretion of the treating physician.
Docetaxel
Docetaxel will be administered as intravenous infusion Q3W as per discretion of the treating physician. Protocol amendment 2 (dated 17-Feb-2011) removed the option to choose docetaxel.
Bevacizumab 15 mg/kg Q3W
Participants will receive bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
Bevacizumab
Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion.
Paclitaxel
Paclitaxel will be administered as intravenous infusion Q1W as per discretion of the treating physician.
Docetaxel
Docetaxel will be administered as intravenous infusion Q3W as per discretion of the treating physician. Protocol amendment 2 (dated 17-Feb-2011) removed the option to choose docetaxel.
Interventions
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Bevacizumab
Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion.
Paclitaxel
Paclitaxel will be administered as intravenous infusion Q1W as per discretion of the treating physician.
Docetaxel
Docetaxel will be administered as intravenous infusion Q3W as per discretion of the treating physician. Protocol amendment 2 (dated 17-Feb-2011) removed the option to choose docetaxel.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant who in the Investigator's opinion requires combination therapy for their disease
* Life expectancy of greater than or equal to (\>/=)12 weeks
Exclusion Criteria
* Participants currently undergoing radiation therapy for the treatment of metastatic disease (apart from the relief of metastatic bone pain)
* Major surgery or significant traumatic injury within 28 days prior to enrollment or anticipation of the need for major surgery during study treatment
18 Years
FEMALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Bangor, , United Kingdom
Cottingham, , United Kingdom
Exeter, , United Kingdom
Grimsby, , United Kingdom
Harrogate, , United Kingdom
Plymouth, , United Kingdom
Portsmouth, , United Kingdom
Preston, , United Kingdom
Somerset, , United Kingdom
Wolverhampton, , United Kingdom
Countries
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Other Identifiers
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2009-014279-37
Identifier Type: -
Identifier Source: secondary_id
ML22780
Identifier Type: -
Identifier Source: org_study_id
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