A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab) and Xeloda (Capecitabine) in Patients With HER2-Positive Breast Cancer
NCT ID: NCT00811135
Last Updated: 2016-09-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
88 participants
INTERVENTIONAL
2008-12-31
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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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
bevacizumab [Avastin]
15mg/kg iv on day 2 of first 3-week cycle,and on day 1 of subsequent cycles
capecitabine [Xeloda]
1000mg/m2 bid po on days 1-14 of each 3-week cycle
trastuzumab [Herceptin]
8mg/kg iv loading dose on day 1 of first 3-week cycle, followed by 6mg/kg iv maintenance dose on day 1 of subsequent cycles
Interventions
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bevacizumab [Avastin]
15mg/kg iv on day 2 of first 3-week cycle,and on day 1 of subsequent cycles
capecitabine [Xeloda]
1000mg/m2 bid po on days 1-14 of each 3-week cycle
trastuzumab [Herceptin]
8mg/kg iv loading dose on day 1 of first 3-week cycle, followed by 6mg/kg iv maintenance dose on day 1 of subsequent cycles
Eligibility Criteria
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Inclusion Criteria
* breast cancer with measurable locally recurrent or metastatic lesions;
* candidate for chemotherapy;
* HER2-positive disease;
* ECOG PS of \<=2.
Exclusion Criteria
* previous radiotherapy for metastatic breast cancer (except for adjuvant radiotherapy \>=6 months before enrollment);
* chronic daily treatment with corticosteroids (\>=10mg/day), aspirin (\>325 mg/day) or clopidogrel (\>75mg/day);
* other primary tumor within last 5 years, except for adequately treated cervical cancer in situ, squamous or basal cell skin cancer;
* uncontrolled hypertension or significant cardiovascular disease.
18 Years
ALL
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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Herlev, , Denmark
Vejle, , Denmark
Aix-en-Provence, , France
Béziers, , France
Créteil, , France
Dechy, , France
Lormont, , France
Marseille, , France
Narbonne, , France
Paris, , France
Paris, , France
Paris, , France
Paris, , France
Rodez, , France
Saint-Jean, , France
Saint-Quentin, , France
Toulouse, , France
Moscow, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Bratislava, , Slovakia
Barcelona, Barcelona, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Málaga, Malaga, Spain
Pontevedra, Pontevedra, Spain
Salamanca, Salamanca, Spain
Seville, Sevilla, Spain
Valencia, Valencia, Spain
Valencia, Valencia, Spain
Barakaldo, Vizcaya, Spain
Eskilstuna, , Sweden
Sundsvall, , Sweden
Uppsala, , Sweden
Vaxjo, , Sweden
Countries
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References
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Martin M, Makhson A, Gligorov J, Lichinitser M, Lluch A, Semiglazov V, Scotto N, Mitchell L, Tjulandin S. Phase II study of bevacizumab in combination with trastuzumab and capecitabine as first-line treatment for HER-2-positive locally recurrent or metastatic breast cancer. Oncologist. 2012;17(4):469-75. doi: 10.1634/theoncologist.2011-0344. Epub 2012 Mar 30.
Other Identifiers
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2008-003283-20
Identifier Type: -
Identifier Source: secondary_id
MO21926
Identifier Type: -
Identifier Source: org_study_id
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