Detail of the clinical trial
| Title of the trial | A RANDOMIZED, MULTICENTER, OPEN LABEL PHASE III STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TRASTUZUMAB EMTANSINE VERSUS TRASTUZUMAB AS ADJUVANT THERAPY FOR PATIENTS WITH HER2-POSITIVE PRIMARY BREAST CANCER WHO HAVE RESIDUAL TUMOR PRESENT PATHOLOGICALLY IN THE BREAST OR AXILLARY LYMPH NODES FOLLOWING PREOPERATIVE THERAPY. |
|---|---|
| EudraCT number | 2012-002018-37 |
| Protocol number | BO27938 |
| Sponsor | F. Hoffmann-La Roche Ltd,Grenzacherstrasse 124,Basel,4070 |
| Indications | Oncology |
| Diagnosis | Breast Cancer |
| Population in clinical trial |
Adults (18-65 years) Elderly ( > 65 years) Male Female Patients |
| Year of receiving the request to Institute (SÚKL) | 2013 |
| Date of approval by Institute (SÚKL) | 22.2.2013 |
| Date of approval by EC | 4.4.2013 |
| Date of initiation CT in ČR | 6.6.2013 |
| Date of ending CT in ČR | |
| Notice | |
| Sites |
Radiologické centrum , Multiscan s.r.o. Všeobecná fakultní nemocnice v Praze,Onkologická klinika,U nemocnice 2,Praha 2,12808 Fakultní nemocnice Hradec Králové,Klinika onkologie a radioterapie,Sokolská 581,Hradec Králové ,50005 Fakultní nemocnice Olomouc,Onkologická klinika,I.P. Pavlova 6,Olomouc,77520 |
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