EORTC protocol 10112 - Aphinity

A randomized multicenter, double-blind, placebo-controlled comparison of chemotherapy plus trastuzumab plus placebo versus chemotherapy plus trastuzumab plus pertuzumab as adjuvant therapy in patients with operable HER2-positive primary breast cancer.
Trial StatusRecruiting
DatesDate of activation: 08-Nov-11
Data management at EORTCMailbox
Phase3
Randomized trialYes
TypeAdjuvant
Targeted Sample sizeEORTC Groups: 3806 - All Groups: 3806
Number of steps1
DrugFluorouracil
Carboplatin
Cyclophosphamide
Docetaxel
Doxorubicin
Epirubicin
Pertuzumab
Paclitaxel
Trastuzumab
Study StaffFatima Cardoso (Study Coordinator) - Champalimaud Cancer Center, Lisboa
Jan Bogaerts (Statistician) - EORTC Headquarters, Brussels
Carlo Messina (Coordinating Physician) - EORTC Headquarters, Brussels
Melanie Beauvois (Project Manager) - EORTC Headquarters, Brussels, melanie.beauvois( at )eortc.be, +32 27741687
Type of cancerBreast
Participating GroupsBreast International Group(Coordinating Group)
EORTC Breast Cancer Group
Centers authorized by EORTC Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet (Brussels, Belgium) - Inst. 101
Universitair Ziekenhuis Antwerpen (Edegem, Belgium) - Inst. 117
Cliniques Universitaires De Mont Godinne (Yvoir, Belgium) - Inst. 123
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium) - Inst. 147
AZ Groeninge Kortrijk - Campus Loofstraat (Kortrijk, Belgium) - Inst. 1257
Rambam Medical Center (Haifa, Israel) - Inst. 910
Protocol summaryCancer.gov (PDQ)
ClinicalTrials.gov
NCT numberNCT01358877
EudraCT2010-022902-41
Protocol documents in PDF
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Study documentation
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