ホルモン受容体陽性かつHER2陰性の局所進行性切除不能または転移性乳がん患者を対象とした、イパタセルチブ＋パルボシクリブ＋フルベストラント療法とプラセボ＋パルボシクリブ＋フルベストラント療法の比較試験

基本情報

NCT ID

NCT04060862

ステータス

中止

試験のフェーズ

第1相

試験タイプ

介入

目標被験者数

20

治験依頼者名

Hoffmann-La Roche

概要

The open-label Phase Ib portion of this study will evaluate the safety and pharmacokinetics of ipatasertib in combination with palbociclib and fulvestrant to identify a dose of ipatasertib that can be combined with palbociclib and fulvestrant in the Phase III portion. The randomized Phase III portion of this study will evaluate the efficacy, safety, and patient-reported outcome (PRO) objectives of ipatasertib + palbociclib + fulvestrant compared with placebo + palbociclib + fulvestrant in patients with HR+ HER2-, locally advanced unresectable or metastatic breast cancer who had relapsed during adjuvant endocrine therapy or progressed during the initial 12 months of first-line endocrine therapy in locally advanced unresectable or metastatic breast cancer.

対象疾患

介入

依頼者（Sponsor）

実施施設 (2)