A Study of Avastin (Bevacizumab) in Patients With Inflammatory or Locally Advanced Breast Cancer
NCT ID: NCT00559845
Last Updated: 2018-04-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
56 participants
INTERVENTIONAL
2008-02-29
2015-07-31
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
Participants will receive FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.
5-fluorouracil
600 milligrams per meter squared (mg/m\^2) as an intravenous (i.v.) bolus over ≤15 minutes every 3 weeks for 4 cycles.
Epidoxorubicin
90 mg/m\^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles.
Cyclophosphamide
600 mg/m\^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles.
Paclitaxel
Paclitaxel was administered at 80 mg/m\^2 i.v. over 1 hour weekly for 12 weeks.
Bevacizumab
Bevacizumab was administered at 10 milligrams per kilogram (mg/kg) i.v. every 2 weeks for 6 cycles.
Interventions
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5-fluorouracil
600 milligrams per meter squared (mg/m\^2) as an intravenous (i.v.) bolus over ≤15 minutes every 3 weeks for 4 cycles.
Epidoxorubicin
90 mg/m\^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles.
Cyclophosphamide
600 mg/m\^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles.
Paclitaxel
Paclitaxel was administered at 80 mg/m\^2 i.v. over 1 hour weekly for 12 weeks.
Bevacizumab
Bevacizumab was administered at 10 milligrams per kilogram (mg/kg) i.v. every 2 weeks for 6 cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* stage III, or inflammatory breast cancer;
* estrogen receptor/progesterone receptor (ER/PgR) positive or negative and human epidermal growth factor receptor 2 (HER-2) negative;
* normal left ventricular ejection fraction (LVEF).
Exclusion Criteria
* evidence of distant metastatic disease;
* other primary tumors in last 5 years (except for adequately treated cancer in situ of the cervix, or basal cell skin cancer);
* chronic daily treatment with \>325 milligram per day (mg/day) aspirin, or \>75mg/day clopidogrel.
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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Napoli, Campania, Italy
Reggio Emilia, Emilia-Romagna, Italy
Pordenone, Friuli Venezia Giulia, Italy
Genoa, Liguria, Italy
Mantova, Lombardy, Italy
Cuneo, Piedmont, Italy
Turin, Piedmont, Italy
Negrar, Veneto, Italy
Countries
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References
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Clavarezza M, Turazza M, Aitini E, Saracchini S, Garrone O, Durando A, De Placido S, Bisagni G, Levaggi A, Bighin C, Restuccia E, Scalamogna R, Galli A, Del Mastro L. Phase II open-label study of bevacizumab combined with neoadjuvant anthracycline and taxane therapy for locally advanced breast cancer. Breast. 2013 Aug;22(4):470-5. doi: 10.1016/j.breast.2013.03.012. Epub 2013 May 1.
Other Identifiers
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2006-003291-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ML19884
Identifier Type: -
Identifier Source: org_study_id
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