閉経後女性におけるER陽性、HER2陰性の転移性または局所進行性乳がんに対するエベロリムスとレトロゾールの併用療法に関する非盲検第II相試験

基本情報

NCT ID: NCT01698918
ステータス: 完了
試験のフェーズ: 第2相
試験タイプ: 介入
目標被験者数: 202
治験依頼者名: Novartis

概要

The purpose of this study was to assess the efficacy and safety of first-line treatment with everolimus plus letrozole in postmenopausal women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer. Moreover, the study also aimed to investigate the efficacy and safety of second line treatment with everolumus plus examestane in participants whose disease progressed during everolimus plus letrozole therapy.

対象疾患

Hormone Receptor Positive Breast Cancer

介入

Everolimus(DRUG)

Letrozole(DRUG)

Exemestane(DRUG)

Alcohol-free dexamethasone mouth rinse (Stomatitis sub-study)(DRUG)

Standard of care to treat stomatitis (Stomatitis sub-study)(DRUG)

依頼者（Sponsor）

ノバルティスファーマ株式会社(INDUSTRY)