A Study of Herceptin (Trastuzumab) in Combination With 2nd-Line Chemotherapy in Patients With HER2 Positive Metastatic Breast Cancer.
NCT ID: NCT00444587
Last Updated: 2016-06-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
114 participants
INTERVENTIONAL
2007-03-31
2011-08-31
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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Trastuzumab + 2nd Line Chemotherapy
Second line chemotherapy
As prescribed
trastuzumab [Herceptin]
6mg/kg iv every 3 weeks
Only Chemotherapy
Second line chemotherapy
As prescribed
Interventions
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Second line chemotherapy
As prescribed
trastuzumab [Herceptin]
6mg/kg iv every 3 weeks
Eligibility Criteria
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Inclusion Criteria
* metastatic breast cancer;
* HER2 overexpression (IHC 3+ and/or FISH positive);
* disease progression during or after previous 1st line chemotherapy + Herceptin;
* scheduled to receive 2nd line chemotherapy.
Exclusion Criteria
* anthracyclines as part of previous 1st line chemotherapy or planned 2nd line chemotherapy;
* cardiac toxicity during previous 1st line chemotherapy + Herceptin;
* history of other malignancy within last 5 years.
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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Sofia, , Bulgaria
Tallinn, , Estonia
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Győr, , Hungary
Gyula, , Hungary
Nyíregyháza, , Hungary
Szeged, , Hungary
Székesfehérvár, , Hungary
Szombathely, , Hungary
Haifa, , Israel
Holon, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Rehovot, , Israel
Safed, , Israel
Tel Aviv, , Israel
Ẕerifin, , Israel
Kaunas, , Lithuania
Vilnius, , Lithuania
Skopje, , North Macedonia
Bratislava, , Slovakia
Košice, , Slovakia
Adana, , Turkey (Türkiye)
Ankara, , Turkey (Türkiye)
Countries
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Other Identifiers
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ML19944
Identifier Type: -
Identifier Source: org_study_id
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