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進行癌に対する全身治療を受けていないER陽性HER2陰性乳癌患者を対象としたAZD9833+パルボシクリブとアナストロゾール+パルボシクリブの比較試験

基本情報

NCT ID
NCT04711252
ステータス
実施中(募集終了)
試験のフェーズ
第3相
試験タイプ
介入
目標被験者数
1,370
治験依頼者名
AstraZeneca

概要

The study is intended to show superiority of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) versus anastrozole (an aromatase inhibitor) and palbociclib as the initial treatment of patients with hormone receptor-positive (ER-positive), human epidermal growth factor 2-negative (HER2-negative) advanced/metastatic breast cancer. INFORMATION FOR TRIAL PARTICIPANTS In this trial, the researchers will look at how well camizestrant with palbociclib works, compared with anastrozole with palbociclib, in participants with breast cancer that has either spread into other parts of the body at the time of diagnosis, or has come back after at least 2 years of standard endocrine treatment. Participants in this trial will have breast cancer that has ER proteins but does not have overexpression of HER2 protein.

対象疾患

ER-Positive HER2-Negative Breast Cancer

介入

AZD9833(DRUG)
Anastrozole(DRUG)
Anastrozole placebo(DRUG)
AZD9833 placebo(DRUG)
Palbociclib(DRUG)
Luteinizing hormone-releasing hormone (LHRH) agonist(DRUG)

依頼者(Sponsor)