ヒト上皮成長因子受容体2（HER2）陽性転移性胃食道接合部癌または胃癌患者におけるペルツズマブとトラスツズマブおよび化学療法との併用療法に関する研究

基本情報

NCT ID

NCT01774786

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

780

治験依頼者名

Hoffmann-La Roche

概要

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.

対象疾患

介入

依頼者（Sponsor）

実施施設 (13)