A Double-Blind, Placebo-Controlled, Randomized, Multicenter Phase III Study Evaluating the Efficacy and Safety of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Metastatic Gastroesophageal Junction and Gastric Cancer
A Double-Blind, Placebo-Controlled, Randomized, Multicenter Phase III Study Evaluating the Efficacy and Safety of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Metastatic Gastroesophageal Junction and Gastric Cancer
This double-blind, placebo-controlled, randomized, multicenter, international, parallel arm study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab, fluoropyrimidine and cisplatin as first-line treatment in participants with HER2-positive metastatic gastroesophageal junction (GEJ) or gastric cancer (GC). Participants will be randomized to receive pertuzumab 840 milligrams (mg) or placebo intravenously every 3 weeks (q3w) in combination with trastuzumab (initial dose of 8 milligrams per kilogram [mg/kg] intravenously [IV] followed by 6 mg/kg IV q3w) and cisplatin and fluoropyrimidine (capecitabine or 5-fluorouracil) for the first 6 treatment cycles. Participants will continue to receive pertuzumab or placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Inclusion Criteria:
Exclusion Criteria:
Chicago, Illinois 60637, United States
New York, New York 10065, United States
Charleston, South Carolina 29425, United States
Zams, 6511, Austria
Varna, 9010, Bulgaria
Beijing, 100071, China
Shijiazhuang, 050035, China
Xi'an, 710032, China
Berlin, 10117, Germany
Essen, 45136, Germany
Esslingen am Neckar, 73730, Germany
Mainz, 55131, Germany
Mannheim, 68167, Germany
Marburg, 35043, Germany
Miskolc, 3526, Hungary
Szeged, 6720, Hungary
Bologna, Emilia-Romagna 40138, Italy
Reggio Emilia, Emilia-Romagna 42100, Italy
Udine, Friuli Venezia Giulia 33100, Italy
Ehime, 791-0280, Japan
Osaka, 541-8567, Japan
Almaty, 050022, Kazakhstan
Sabah, Sabah 88996, Malaysia
Lima, Lima 41, Peru
Warsaw, 02-781, Poland
Seoul, 03080, South Korea
Khonkaen, 40000, Thailand
Edirne, 22770, Turkey (Türkiye)
Erzurum, 25240, Turkey (Türkiye)