術前化学療法および手術後に残存病変を有するホルモン受容体陽性HER2正常患者における標準内分泌療法へのパルボシクリブの追加投与に関する研究

基本情報

NCT ID: NCT01864746
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: 1,250
治験依頼者名: GBG Forschungs GmbH

概要

The PENELOPEB study is designed to demonstrate that, in the background of standard anti-hormonal therapy, palbociclib provides superior invasive disease-free survival (iDFS) compared to placebo in pre- and postmenopausal women with HR-positive/HER2-normal early breast cancer at high risk of relapse after showing less than pathological complete response to neoadjuvant taxane- containing chemotherapy. Considering the high risk of recurrence in patients after neoadjuvant chemotherapy and a high CPS-EG score, palbociclib appears to be an attractive option with a favourable safety profile for these patients.

対象疾患

Breast CancerHormonreceptor PositiveHer2-normalPostneoadjuvant Treatment With CDK 4/6 InhibitorCPS-EG Score

介入

Palbociclib PD-0332991(DRUG)

Placebo(DRUG)

依頼者（Sponsor）

Gbg Forschungs(OTHER)

ファイザー株式会社(INDUSTRY)

Ago Study Group(OTHER)

Nsabp Foundation(NETWORK)

Breast International Group(OTHER)

実施施設 (1)

三河乳がんクリニック

Tokyo, Japan