ホルモン受容体陽性、HER2陰性の進行乳がんを有する閉経前（ゴセレリン併用）および閉経後女性を対象とした、LEE011とレトロゾールの併用療法の第Ib相用量漸増試験およびLEE011とホルモン療法の併用療法の用量拡大試験

基本情報

NCT ID: NCT02333370
ステータス: 完了
試験のフェーズ: 第1相
試験タイプ: 介入
目標被験者数: 88
治験依頼者名: Novartis

概要

The purpose of the Phase Ib is to: 1. determine the recommended dose of LEE011 in combination with a standard dose of letrozole as well as to provide additional safety and anti-tumor activity data in Asian non-Japanese patients 2. determine the recommended dose of LEE011 in combination with a standard dose of letrozole as well as to provide additional safety and activity data in Japanese patients 3. evaluate the safety and anti-tumor activity of LEE011 at the RP2D established in the dose escalation part in combination with a standard dose of letrozole, fulvestrant or tamoxifen plus goserelin in Japanese patients.

対象疾患

Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

介入

LEE011(DRUG)

Letrozole(DRUG)

Tamoxifen(DRUG)

Fulvestrant(DRUG)

goserelin(DRUG)

依頼者（Sponsor）

ノバルティスファーマ株式会社(INDUSTRY)