A Phase III Prospective, Two-Cohort Non-Randomized, Multi-Centre, Multinational, Open-Label Study to Assess the Safety of Assisted- and Self-Administered Subcutaneous Trastuzumab as Therapy in Patients With Operable HER2-Positive Early Breast Cancer
A Phase III Prospective, Two-Cohort Non-Randomized, Multi-Centre, Multinational, Open-Label Study to Assess the Safety of Assisted- and Self-Administered Subcutaneous Trastuzumab as Therapy in Patients With Operable HER2-Positive Early Breast Cancer
This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Participants will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle/vial formulation (Cohort A) or with assisted and self-administration using a single-use injection device (SID) in selected participants (Cohort B).
Inclusion Criteria:
Exclusion Criteria:
Vancouver, British Columbia V5Z 4E6, Canada
LeMans, 72000, France
Essen, 45136, Germany
Georgsmarienhütte, 49124, Germany
Halle, 06110, Germany
Hamburg, 20246, Germany
Hanover, 30177, Germany
Hanover, 30625, Germany
Heidelberg, 69120, Germany
Jena, 07747, Germany
Lübeck, 23538, Germany
Mainz, 55131, Germany
Minden, 32429, Germany
München, 80638, Germany
Stendal, 39576, Germany
Heraklion, 711 10, Greece
Central Jakarta, 10430, Indonesia
East Java, 60286, Indonesia
Rionero in Vulture, Basilicate 85028, Italy
Naples, Campania 80131, Italy
Meldola, Emilia-Romagna 47014, Italy
Piacenza, Emilia-Romagna 29100, Italy
Rome, Lazio 00161, Italy
Milan, Lombardy 20133, Italy
Turin, Piedmont 10126, Italy
Sabah, Sabah 88996, Malaysia
Sarawak, Sarawak 93586, Malaysia
Queretaro, Queretaro, 76090, Mexico
AC Amsterdam, 1091, Netherlands
Apeldoorn, 7334 DZ, Netherlands
Sittard-Geleen, 6162 BG, Netherlands
Stavanger, 4011, Norway
Lima, Lima 41, Peru
Krakow, 30-688, Poland
Otwock, 05-400, Poland
Rzeszów, 35-021, Poland
Moscow, 115478, Russia
Bratislava, 811 05, Slovakia
Santander, Cantabria 39008, Spain
Donostia / San Sebastian, Guipuzcoa 20014, Spain
Las Palmas de Gran Canaria, LAS Palmas 35016, Spain
Las Palmas de Gran Canaria, LAS Palmas 35020, Spain
Navarra, Navarre 31008, Spain
San Cristóbal de La Laguna, Tenerife 38320, Spain
Santa Cruz de Tenerife, Tenerife 38010, Spain
Jaén, 23007, Spain
Madrid, 28050, Spain
Chiang Mai, 50200, Thailand
Sihhiye/Ankara, 06230, Turkey (Türkiye)
Berkshire, SL2 4HL, United Kingdom
Denbighshire, LL18 5UJ, United Kingdom
Devon, EX31 4JB, United Kingdom
New Castle Upon Tyne, NE7 7DN, United Kingdom
Swindon, SN3 6BB, United Kingdom
Winchester, SO22 5DG, United Kingdom
Montevideo, 11400, Uruguay