THOR Study: A Study of Continued Herceptin (Trastuzumab) in Combination With Second Line Chemotherapy in Patients With HER2 Positive Metastatic Breast Cancer.
NCT ID: NCT00448279
Last Updated: 2014-10-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
58 participants
INTERVENTIONAL
2007-04-30
2010-09-30
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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Chemotherapy Alone
Chemotherapy, schedule and dose at the investigator's discretion.
Chemotherapy
Schedule and dose at the investigator's discretion
Chemotherapy, Trastuzumab
Trastuzumab, at the investigator's discretion, either 2 milligrams per kilogram (mg/kg) intravenous (i.v.) every 7 days or 6 mg/kg i.v. every 3 weeks. Chemotherapy, schedule and dose at the investigator's discretion.
trastuzumab
2mg/kg i.v. weekly, or 6mg/kg i.v. every 3 weeks
Chemotherapy
Schedule and dose at the investigator's discretion
Interventions
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trastuzumab
2mg/kg i.v. weekly, or 6mg/kg i.v. every 3 weeks
Chemotherapy
Schedule and dose at the investigator's discretion
Other Intervention Names
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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 plus Herceptin;
* scheduled to receive 2nd line chemotherapy.
Exclusion Criteria
* pregnancy.
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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Avellino, , Italy
Brescia, , Italy
Candiolo, , Italy
Carrara, , Italy
Cona (Ferrara), , Italy
Cosenza, , Italy
Crotone - Kr, , Italy
Fano, , Italy
Florence, , Italy
Frattaminore, , Italy
Genova, , Italy
Lecce, , Italy
Livorno, , Italy
Mantova, , Italy
Meldola, , Italy
Napoli, , Italy
Nocera Inferiore, , Italy
Padua, , Italy
Palermo, , Italy
Pavia, , Italy
Perugia, , Italy
Pordenone, , Italy
Potenza, , Italy
Ragusa, , Italy
Reggio Calabria, , Italy
Rionero in Vulture, , Italy
Roma, , Italy
Roma, , Italy
Salerno, , Italy
San Giovanni Rotondo, , Italy
Sassari, , Italy
Sora, , Italy
Taormina, , Italy
Torino, , Italy
Udine, , Italy
Countries
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Other Identifiers
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ML18742
Identifier Type: -
Identifier Source: org_study_id
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