174
Participants
Start Date
February 21, 2014
Primary Completion Date
December 22, 2016
Study Completion Date
November 25, 2018
Trastuzumab
Trastuzumab will be administered subcutaneously at a fixed dose of 600 mg (irrespective of body weight) every 3 weeks for 1 year (adjuvant or neo-adjuvant plus adjuvant therapy).
Doxorubicin
Doxorubicin will be administered in combination with trastuzumab and cyclophosphamide in the adjuvant setting as per local Product Information and the investigator's discretion.
Cyclophosphamide
Cyclophosphamide will be administered in combination with trastuzumab and doxorubicin in the adjuvant setting as per local Product Information and the investigator's discretion.
Paclitaxel
Paclitaxel will be administered in combination with trastuzumab in the adjuvant setting as per local Product Information and the investigator's discretion.
Docetaxel
Docetaxel will be administered in combination with trastuzumab in the adjuvant setting as per local Product Information and the investigator's discretion.
Carboplatin
Carboplatin will be administered in combination with trastuzumab and docetaxel in the adjuvant setting as per local Product Information and the investigator's discretion.
Neo-adjuvant chemotherapy
Neo-adjuvant chemotherapy will be administered according to local guidelines in combination with trastuzumab in the neo-adjuvant setting. The study protocol does not mention any specific neo-adjuvant chemotherapy drug names.
Institut Salah Azaïz; Service de Médecine Carcinologique, Tunis
Abderrahmen Mami Hospital; Medical Oncology department, Aryanah
Habib Bourguiba Hospital; Oncology department, Sfax
Farhat Hached Hospital; Oncology department, Sousse
Institut National D'oncologie Sidi Med Benabdellah, Rabat
King Khaled Uni Hospital; Oncology, Riyadh
Centre hospitalo-univerisitaire de Rouiba;Service d'oncologie médicale, Algiers
Centre Anti Cancer Beau-fraisier;Service d'oncologie médicale, Algiers
Clinique Littoral, Casablanca
Dicle University Faculty of Medicine, Diyarbakır
International Medical Center (IMC), Jeddah
Trakya University Medical Faculty, Edirne
CHU Annaba; Service d'Oncologie Médicale, Annaba
Gaziantep Univ. Med. Fac., Gaziantep
EHS Oncologie Emir Abdelkader Oran; Service d'Oncologie Médicale, Oran
İstanbul Üniversitesi Cerrahpaşa Tıp Fakültesi, Istanbul
Bezmialem Vakif Univ Medical, Istanbul
Marmara Uni Faculty of Medicine; Medical Oncology, Istanbul
Ege University Medical Faculty, Izmir
Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie, Marrakesh
Gazi University Medical Faculty; Department of İnternal Medicine, Ankara
Akdeniz Univesity Medical Faculty, Antalya
Hacettepe Uni Medical Faculty Hospital; Oncology Dept, Sıhhiye, Ankara
Hoffmann-La Roche
INDUSTRY