A Phase III, Randomized Open-Label Study to Compare the Pharmacokinetics, Efficacy, and Safety of Subcutaneous (SC) Trastuzumab With Intravenous (IV) Trastuzumab Administered in Women With HER2-Positive Early Breast Cancer (EBC)
A Phase III, Randomized Open-Label Study to Compare the Pharmacokinetics, Efficacy, and Safety of Subcutaneous (SC) Trastuzumab With Intravenous (IV) Trastuzumab Administered in Women With HER2-Positive Early Breast Cancer (EBC)
In this open-label multicenter trial, participants with operable or locally advanced breast cancer will be randomized to pre-operative treatment with 8 cycles of chemotherapy (4 cycles of docetaxel followed by 4 cycles of 5-fluorouracil, epirubicin, and cyclophosphamide) concurrent with either SC Herceptin or IV Herceptin. After surgery, participants will receive a further 10 cycles of SC or IV Herceptin as per randomization to complete 1 year of treatment. All cycles will be 21 days in length. After the end of study treatment, participants will be followed for safety and efficacy for up to 5 years or until disease recurrence, whichever is earlier.
Inclusion Criteria:
Exclusion Criteria:
Prague, 180 81, Czechia
Hanover, 30177, Germany
Szeged, 6720, Hungary
Naples, Campania 80131, Italy
Arequipa, 04001, Peru
Warsaw, 02-781, Poland
Saint Petersburg, Sankt-Peterburg 197758, Russia
Pyatigorsk, 357502, Russia
Stavropol, 355045, Russia
Parktown, Johannesburg, 2193, South Africa
Seoul, 138-736, South Korea
Santiago de Compostela, LA Coruña 15706, Spain