A Study of Avastin (Bevacizumab) + Xeloda (Capecitabine)as Maintenance Therapy in Patients With HER2-Negative Metastatic Breast Cancer
NCT ID: NCT00929240
Last Updated: 2015-03-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
287 participants
INTERVENTIONAL
2009-07-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Avastin (bevacizumab)
bevacizumab [Avastin]
15 mg/kg iv on day 1 of each 3 week cycle (maintenance phase)
Avastin (bevacizumab) + Xeloda (capecitabine)
bevacizumab [Avastin]
15 mg/kg iv on day 1 of each 3 week cycle (maintenance phase)
capecitabine [Xeloda]
1000 mg/m2 po bid on days 1-14 of each 3 week cycle (maintenance phase)
Interventions
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bevacizumab [Avastin]
15 mg/kg iv on day 1 of each 3 week cycle (maintenance phase)
capecitabine [Xeloda]
1000 mg/m2 po bid on days 1-14 of each 3 week cycle (maintenance phase)
Eligibility Criteria
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Inclusion Criteria
* HER2-negative metastatic breast cancer
* candidates for taxane-based chemotherapy;
* ECOG performance status of 0 or 1.
Exclusion Criteria
* prior adjuvant/neo-adjuvant chemotherapy within 6 months prior to study;
* prior radiotherapy for treatment of metastatic disease;
* chronic daily treatment with 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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Fortaleza, Ceará, Brazil
Belo Horizonte, Minas Gerais, Brazil
Rio de Janeiro, Rio de Janeiro, Brazil
Ijuí, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Jaú, São Paulo, Brazil
Santo André, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Beijing, , China
Beijing, , China
Beijing, , China
Hangzhou, , China
Hangzhou, , China
Shanghai, , China
Alexandria, , Egypt
Cairo, , Egypt
Amiens, , France
Angers, , France
Besançon, , France
Bobigny, , France
Dijon, , France
Hyères, , France
Le Coudray, , France
Lille, , France
Paris, , France
Paris, , France
Périgueux, , France
Rodez, , France
Saint-Priest-en-Jarez, , France
Strasbourg, , France
Hong Kong, , Hong Kong
Hong Kong, , Hong Kong
Bangalore, , India
Hyderabad, , India
Mumbai, , India
Mumbai, , India
New Delhi, , India
New Delhi, , India
Brindisi, Apulia, Italy
Napoli, Campania, Italy
Trieste, Friuli Venezia Giulia, Italy
Genoa, Liguria, Italy
Saronno, Lombardy, Italy
Antella (FI), Tuscany, Italy
Bydgoszcz, , Poland
Wroclaw, , Poland
Dammam, , Saudi Arabia
Jeddah, , Saudi Arabia
Jeddah, , Saudi Arabia
Alcoy, Alicante, Spain
Sabadell, Barcelona, Barcelona, Spain
Alcazar de S. Juan, Ciudad Real, Spain
Jaén, Jaen, Spain
Málaga, Malaga, Spain
Toledo, Toledo, Spain
Valencia, Valencia, Spain
Barakaldo, Vizcaya, Spain
Ankara, , Turkey (Türkiye)
Ankara, , Turkey (Türkiye)
Antalya, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Sıhhiye, Ankara, , Turkey (Türkiye)
Countries
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References
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Gligorov J, Doval D, Bines J, Alba E, Cortes P, Pierga JY, Gupta V, Costa R, Srock S, de Ducla S, Freudensprung U, Mustacchi G. Maintenance capecitabine and bevacizumab versus bevacizumab alone after initial first-line bevacizumab and docetaxel for patients with HER2-negative metastatic breast cancer (IMELDA): a randomised, open-label, phase 3 trial. Lancet Oncol. 2014 Nov;15(12):1351-60. doi: 10.1016/S1470-2045(14)70444-9. Epub 2014 Sep 28.
Other Identifiers
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2008-006872-31
Identifier Type: -
Identifier Source: secondary_id
MO22223
Identifier Type: -
Identifier Source: org_study_id
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