A Study of Avastin (Bevacizumab) in Combination With Taxane-based Chemotherapy as First Line Treatment in Patients With HER-2 Negative Breast Cancer
NCT ID: NCT00846027
Last Updated: 2014-07-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2009-01-31
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bevacizumab + paclitaxel + gemcitabine
Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m\^2 IV, and gemcitabine 2000 mg/m\^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
Bevacizumab
Bevacizumab was supplied as a sterile liquid in glass vials.
Paclitaxel
Paclitaxel was supplied as a sterile liquid in glass vials.
Gemcitabine
Gemcitabine was supplied as a sterile liquid in glass vials.
Interventions
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Bevacizumab
Bevacizumab was supplied as a sterile liquid in glass vials.
Paclitaxel
Paclitaxel was supplied as a sterile liquid in glass vials.
Gemcitabine
Gemcitabine was supplied as a sterile liquid in glass vials.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Breast cancer, with measurable, locally recurrent or metastatic lesions, or patients with bone metastasis only.
* HER-2 negative disease.
* Candidates for chemotherapy.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Exclusion Criteria
* Previous radiotherapy for treatment of metastatic breast cancer.
* Any prior adjuvant treatment with anthracyclines completed \< 6 months prior to enrollment.
* Chronic daily treatment with corticosteroids (≥ 10 mg/day), aspirin (\> 325 mg/day) or clopidogrel (\> 75mg/day).
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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Elda, Alicante, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Manresa, Barcelona, Spain
Burgos, Burgos, Spain
Cadiz, Cadiz, Spain
Córdoba, Cordoba, Spain
Granada, Granada, Spain
Granada, Granada, Spain
Huelva, Huelva, Spain
Jaén, Jaen, Spain
Las Palmas de Gran Canaria, Las Palmas, Spain
Lugo, Lugo, Spain
Alcorcón, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Marbella, Malaga, Spain
Murcia, Murcia, Spain
Vigo, Pontevedra, Spain
Seville, Sevilla, Spain
Seville, Sevilla, Spain
Sagunto, Valencia, Spain
Zaragoza, Zaragoza, Spain
Countries
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Other Identifiers
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2008-003657-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ML21999
Identifier Type: -
Identifier Source: org_study_id
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