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カミゼストラントとパルボシクリブの併用が、ER タンパク質を有するが HER2 タンパク質の過剰発現を示さないタイプの進行性乳がんの参加者でどのように機能するかを調べるための試験。 (SERENA-4)

2026年9月24日 更新者：AstraZeneca

SERENA-4：未治療のエストロゲン受容体陽性、HER2 陰性進行乳癌患者の治療のための AZD9833（経口 SERD）とパルボシクリブ、アナストロゾールとパルボシクリブの無作為化多施設二重盲検第 III 相試験進行疾患に対する全身治療

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.

調査の概要

状態

積極的、募集していない

条件

介入・治療

詳細な説明

A Randomised, Multicentre, Double-Blind, Phase III study will evaluate the safety and efficacy of AZD9833 (next generation oral SERD) in combination with palbociclib versus anastrozole in combination with palbociclib for the treatment of patients with ER-positive breast cancer. The goal of the study is to demonstrate superiority of AZD9833 over anastrozole in the context of combination with palbociclib in first line setting.

INFORMATION FOR TRIAL PARTICIPANTS

Researchers are looking for a better way to treat breast cancer.

In people with cancer, some cells have grown out of control to form tumours.

The trial drugs palbociclib, camizestrant, and anastrozole are designed to work by blocking the cancer's ability to grow. Camizestrant is also called AZD9833. Palbociclib and anastrozole are already available as treatments for people with certain type of breast cancer.

In this trial, the researchers want to find out how well taking camizestrant with palbociclib, or anastrozole with palbociclib, works in participants with breast cancer that has ER proteins but does not have overexpression of HER2 protein.

The researchers will look at which trial treatments help the participants live longer with cancer before it gets worse.

The trial will split participants into 2 groups:

  • Participants in Group 1 will take camizestrant, palbociclib, and a placebo matched with anastrazole.
  • Participants in Group 2 will take anastrozole, palbociclib, , and a placebo matched with camizestrant.

A placebo looks like a treatment but does not have any medicine in it.

A computer program will be used to randomly choose the treatments each participant gets. This helps make sure the groups are chosen fairly. Researchers do this so that comparing the results of each treatment will be as accurate as possible.

The participants will take their trial treatments in periods called "cycles". Each cycle will last 28 days. During each cycle, the participants will take:

  • camizestrant or anastrozole once daily by mouth
  • palbociclib once daily by mouth for 21 days. Then, they will not take any palbociclib for 7 days

Some participants will also get either goserelin or leuprorelin once every month. Participants could get goserelin or leuprorelin if:

  • They are medically determined yet to reach menopause status
  • They are male

They will get this treatment as an injection under the skin or into a muscle. Goserelin and leuprorelin work by decreasing the amount of sex hormones made by the body which will lead to reduction of ER production. This can help stop breast cancer from growing.

Participants will take trial treatment until the cancer gets worse or they leave the trial.

Participants will visit their trial site several times throughout the trial. At these visits, the trial doctors will check the health of the participants. They will also take blood samples and do scans of the participants' tumors.

研究の種類

介入

入学 (実際)

1371

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Alabama
      • Mobile、Alabama、アメリカ、36604
        • Research Site
    • Arkansas
      • Springdale、Arkansas、アメリカ、72762
        • Research Site
    • California
      • Harbor City、California、アメリカ、90710
        • Research Site
      • Solvang、California、アメリカ、93463
        • Research Site
    • Colorado
      • Lone Tree、Colorado、アメリカ、80124
        • Research Site
    • Florida
      • Fort Myers、Florida、アメリカ、33901-8101
        • Research Site
      • Jacksonville、Florida、アメリカ、32256
        • Research Site
      • West Palm Beach、Florida、アメリカ、33401
        • Research Site
    • Indiana
      • Indianapolis、Indiana、アメリカ、46256
        • Research Site
    • Louisiana
      • Baton Rouge、Louisiana、アメリカ、70809
        • Research Site
    • Maryland
      • Silver Spring、Maryland、アメリカ、20904
        • Research Site
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02114
        • Research Site
    • Michigan
      • Detroit、Michigan、アメリカ、48202
        • Research Site
    • Mississippi
      • Hattiesburg、Mississippi、アメリカ、39401
        • Research Site
    • Nebraska
      • Omaha、Nebraska、アメリカ、68130
        • Research Site
    • Ohio
      • Cincinnati、Ohio、アメリカ、45219
        • Research Site
      • Cincinnati、Ohio、アメリカ、45267
        • Research Site
    • Oregon
      • Portland、Oregon、アメリカ、97239
        • Research Site
    • South Carolina
      • West Columbia、South Carolina、アメリカ、29169
        • Research Site
    • South Dakota
      • Sioux Falls、South Dakota、アメリカ、57105
        • Research Site
    • Tennessee
      • Chattanooga、Tennessee、アメリカ、37404
        • Research Site
      • Nashville、Tennessee、アメリカ、37203
        • Research Site
    • Texas
      • Austin、Texas、アメリカ、78731
        • Research Site
      • Houston、Texas、アメリカ、77030
        • Research Site
      • Houston、Texas、アメリカ、77090
        • Research Site
      • Tyler、Texas、アメリカ、75702
        • Research Site
    • Virginia
      • Fairfax、Virginia、アメリカ、22031
        • Research Site
    • Washington
      • Kennewick、Washington、アメリカ、99336
        • Research Site
      • Renton、Washington、アメリカ、98055
        • Research Site
    • West Virginia
      • Morgantown、West Virginia、アメリカ、26505
        • Research Site
  • イギリス
      • Cambridge、イギリス、CB2 2QQ
        • Research Site
      • Colchester、イギリス、CO4 5JL
        • Research Site
      • Leeds、イギリス、LS9 7TF
        • Research Site
      • Nottingham、イギリス、NG5 1PB
        • Research Site
      • Surrey、イギリス、GU2 7XX
        • Research Site
  • イタリア
      • Bergamo、イタリア、24127
        • Research Site
      • Florence、イタリア、50139
        • Research Site
      • Milan、イタリア、20141
        • Research Site
      • Modena、イタリア、41124
        • Research Site
      • Naples、イタリア、80131
        • Research Site
      • Novara、イタリア、28100
        • Research Site
      • Padova、イタリア、35128
        • Research Site
      • Parma、イタリア、43100
        • Research Site
      • Prato、イタリア、59100
        • Research Site
      • Roma、イタリア、00168
        • Research Site
      • Roma、イタリア、161
        • Research Site
      • Rozzano、イタリア、20089
        • Research Site
  • インド
      • Ahmedabad、インド、380060
        • Research Site
      • Calicut、インド、673601
        • Research Site
      • Delhi、インド、110085
        • Research Site
      • Faridabad、インド、121001
        • Research Site
      • Gūrgaon、インド、122001
        • Research Site
      • Karamsad、インド、388325
        • Research Site
      • Kolkata、インド、700160
        • Research Site
      • Madurai、インド、625107
        • Research Site
      • Nagpur、インド、440001
        • Research Site
      • Nashik、インド、422009
        • Research Site
      • Nashik、インド、422011
        • Research Site
      • New Delhi、インド、110029
        • Research Site
  • オーストリア
      • Feldkirch、オーストリア、6807
        • Research Site
      • Salzburg、オーストリア、5020
        • Research Site
      • Vienna、オーストリア、1130
        • Research Site
  • カナダ
      • Montreal、カナダ、H3T 1E2
        • Research Site
    • Alberta
      • Edmonton、Alberta、カナダ、T6G 1Z2
        • Research Site
    • British Columbia
      • Vancouver、British Columbia、カナダ、V5Z 1H7
        • Research Site
    • Ontario
      • Kitchener、Ontario、カナダ、N2G 1G3
        • Research Site
      • London、Ontario、カナダ、N6A 5W9
        • Research Site
      • Toronto、Ontario、カナダ、M5G 2M9
        • Research Site
  • スイス
      • Liestal、スイス、CH- 4410
        • Research Site
      • Zurich、スイス、8008
        • Research Site
  • スペイン
      • Barcelona、スペイン、8035
        • Research Site
      • Barcelona、スペイン、08908
        • Research Site
      • Jaén、スペイン、23007
        • Research Site
      • Lleida、スペイン、25198
        • Research Site
      • Madrid、スペイン、28046
        • Research Site
      • Madrid、スペイン、28040
        • Research Site
      • Málaga、スペイン、29010
        • Research Site
      • Pamplona、スペイン、31005
        • Research Site
      • Santander、スペイン、39008
        • Research Site
      • Seville、スペイン、41013
        • Research Site
      • Valencia、スペイン、46015
        • Research Site
  • スロバキア
      • Banská Bystrica、スロバキア、974 01
        • Research Site
      • Bratislava、スロバキア、833 01
        • Research Site
      • Bratislava、スロバキア、81250
        • Research Site
      • Prešov、スロバキア、081 81
        • Research Site
      • Trenčín、スロバキア、91171
        • Research Site
  • チェコ
      • Hořovice、チェコ、268 01
        • Research Site
      • Hradec Králové、チェコ、500 05
        • Research Site
      • Nový Jičín、チェコ、741 01
        • Research Site
      • Prague、チェコ、100 34
        • Research Site
      • Prague、チェコ、150 06
        • Research Site
      • Prague、チェコ、140 00
        • Research Site
  • チリ
      • Concepción、チリ、4070196
        • Research Site
      • La Serena、チリ、1720430
        • Research Site
      • Santiago、チリ、7630370
        • Research Site
      • Santiago、チリ、8241479
        • Research Site
  • トルコ（Türkiye）
      • Adana、トルコ（Türkiye）、01120
        • Research Site
      • Ankara、トルコ（Türkiye）、06230
        • Research Site
      • Ankara、トルコ（Türkiye）、06010
        • Research Site
      • Ankara、トルコ（Türkiye）、06340
        • Research Site
      • Ankara、トルコ（Türkiye）、6100
        • Research Site
      • Izmir、トルコ（Türkiye）、35100
        • Research Site
      • Izmir、トルコ（Türkiye）、35620
        • Research Site
      • Kayseri、トルコ（Türkiye）、38039
        • Research Site
  • ドイツ
      • Berlin、ドイツ、13125
        • Research Site
      • Dessau-RoBlau、ドイツ、06847
        • Research Site
      • Essen、ドイツ、45136
        • Research Site
      • Freiburg im Breisgau、ドイツ、79110
        • Research Site
      • Mönchengladbach、ドイツ、41061
        • Research Site
      • München、ドイツ、81675
        • Research Site
      • Münster、ドイツ、48145
        • Research Site
      • Regensburg、ドイツ、93053
        • Research Site
      • Velbert、ドイツ、42551
        • Research Site
  • ノルウェー
      • Drammen、ノルウェー、3004
        • Research Site
      • Oslo、ノルウェー、N-0379
        • Research Site
  • ハンガリー
      • Budapest、ハンガリー、1122
        • Research Site
      • Budapest、ハンガリー、1062
        • Research Site
      • Budapest、ハンガリー、1088
        • Research Site
      • Győr、ハンガリー、9024
        • Research Site
      • Miskolc、ハンガリー、3526
        • Research Site
      • Nyíregyháza、ハンガリー、4400
        • Research Site
      • Szekszárd、ハンガリー、7100
        • Research Site
      • Zalaegerszeg、ハンガリー、8900
        • Research Site
  • フランス
      • Besançon、フランス、25030
        • Research Site
      • Bordeaux、フランス、33030
        • Research Site
      • Brest、フランス、29609
        • Research Site
      • Caen、フランス、14076
        • Research Site
      • Dijon、フランス、21079
        • Research Site
      • Le Mans、フランス、72000
        • Research Site
      • Lille、フランス、59000
        • Research Site
      • Montpellier、フランス、34070
        • Research Site
      • Pierre-Bénite、フランス、69495
        • Research Site
      • Plerin SUR MER、フランス、22190
        • Research Site
      • Saint-Cloud、フランス、92210
        • Research Site
      • Vandœuvre-lès-Nancy、フランス、54000
        • Research Site
      • Villejuif、フランス、94805
        • Research Site
  • ブルガリア
      • Plovdiv、ブルガリア、4000
        • Research Site
      • Plovdiv、ブルガリア、4109
        • Research Site
      • Shumen、ブルガリア、9700
        • Research Site
      • Sofia、ブルガリア、1431
        • Research Site
      • Sofia、ブルガリア、1527
        • Research Site
      • Sofia、ブルガリア、1330
        • Research Site
  • ベルギー
      • Anderlecht、ベルギー、1070
        • Research Site
      • Edegem、ベルギー、2650
        • Research Site
      • Ghent、ベルギー、9000
        • Research Site
      • Leuven、ベルギー、3000
        • Research Site
      • Liège、ベルギー、4000
        • Research Site
      • Namur、ベルギー、5000
        • Research Site
      • Sint-Niklaas、ベルギー、9100
        • Research Site
  • ポルトガル
      • Braga、ポルトガル、4710
        • Research Site
      • Guimarães、ポルトガル、4835-044
        • Research Site
      • Lisbon、ポルトガル、1998-018
        • Research Site
      • Lisbon、ポルトガル、1400-038
        • Research Site
      • Lisbon、ポルトガル、1500-650
        • Research Site
      • Loures、ポルトガル、2674-514
        • Research Site
      • Porto、ポルトガル、4099-001
        • Research Site
      • Porto、ポルトガル、4200-319
        • Research Site
      • Vila Nova de Gaia、ポルトガル、4434-502
        • Research Site
  • ポーランド
      • Gdynia、ポーランド、81-519
        • Research Site
      • Konin、ポーランド、62-500
        • Research Site
      • Koszalin、ポーランド、75-581
        • Research Site
      • Lodz、ポーランド、90-302
        • Research Site
      • Lublin、ポーランド、20-090
        • Research Site
      • Olsztyn、ポーランド、10-513
        • Research Site
      • Poznan、ポーランド、60-192
        • Research Site
  • マレーシア
      • George Town、マレーシア、10450
        • Research Site
      • Johor Bahru、マレーシア、81100
        • Research Site
      • Kuala Lumpur、マレーシア、59100
        • Research Site
      • Kuala Lumpur、マレーシア、50586
        • Research Site
      • Kuala Selangor、マレーシア、62250
        • Research Site
      • Kuching、マレーシア、93586
        • Research Site
  • メキシコ
      • Del. Cuauhtemoc、メキシコ、06700
        • Research Site
      • La Paz、メキシコ、23040
        • Research Site
      • Mexico City、メキシコ、0 3100
        • Research Site
      • Monterrey、メキシコ、64710
        • Research Site
      • Puebla City、メキシコ、72424
        • Research Site
      • Toluca、メキシコ、50120
        • Research Site
  • ロシア
      • Kaluga、ロシア、248007
        • Research Site
      • Kislino Village, Ryshkovsky Ru、ロシア、305524
        • Research Site
      • Moscow、ロシア、115478
        • Research Site
      • Moscow、ロシア、117997
        • Research Site
      • Moscow、ロシア、121467
        • Research Site
      • Moscow、ロシア、111123
        • Research Site
      • Saint Petersburg、ロシア、190103
        • Research Site
      • Saint Petersburg、ロシア、197758
        • Research Site
      • Saint Petersburg、ロシア、195067
        • Research Site
      • Saint Petersburg、ロシア、196603
        • Research Site
  • 中国
      • Baoding、中国、071000
        • Research Site
      • Beijing、中国、100142
        • Research Site
      • Beijing、中国
        • Research Site
      • Beijing、中国、100039
        • Research Site
      • Bengbu、中国、233004
        • Research Site
      • Changchun、中国、130021
        • Research Site
      • Changchun、中国、130000
        • Research Site
      • Changsha、中国、410013
        • Research Site
      • Chengdu、中国、610042
        • Research Site
      • Chongqing、中国、400042
        • Research Site
      • Dalian、中国、116011
        • Research Site
      • Guangzhou、中国、510060
        • Research Site
      • Guangzhou、中国、510100
        • Research Site
      • Guiyang、中国、550004
        • Research Site
      • Haikou、中国、570311
        • Research Site
      • Hangzhou、中国、310022
        • Research Site
      • Hangzhou、中国、310020
        • Research Site
      • Hefei、中国、230031
        • Research Site
      • Jinan、中国、250117
        • Research Site
      • Lanzhou、中国、730000
        • Research Site
      • Linyi、中国、276000
        • Research Site
      • Nanchang、中国、330009
        • Research Site
      • Nanjing、中国、210008
        • Research Site
      • Shanghai、中国、200032
        • Research Site
      • Shanghai、中国、200025
        • Research Site
      • Shenyang、中国、110001
        • Research Site
      • Tianjin、中国、300060
        • Research Site
      • Wuhan、中国、430000
        • Research Site
      • Wuhan、中国、430040
        • Research Site
      • Xi'an、中国、710061
        • Research Site
      • Zhengzhou、中国、450008
        • Research Site
  • 台湾
      • Kaohsiung City、台湾、82445
        • Research Site
      • Kaohsiung City、台湾
        • Research Site
      • Taichung、台湾、40443
        • Research Site
      • Tainan、台湾、70403
        • Research Site
      • Taipei、台湾、235
        • Research Site
      • Taipei、台湾、10048
        • Research Site
      • Taipei、台湾、104
        • Research Site
      • Taipei、台湾、110
        • Research Site
      • Taoyuan、台湾、333
        • Research Site
  • 日本
      • Chiba、日本、260-8717
        • Research Site
      • Chūōku、日本、104-0045
        • Research Site
      • Chūōku、日本、862-8655
        • Research Site
      • Hidaka-shi、日本、350-1298
        • Research Site
      • Hirakata-shi、日本、573-1191
        • Research Site
      • Isehara-shi、日本、259-1193
        • Research Site
      • Kitaadachi-gun、日本、362-0806
        • Research Site
      • Kumamoto、日本、860-8556
        • Research Site
      • Kurashiki Shi、日本、701 0192
        • Research Site
      • Kurume-shi、日本、830-0013
        • Research Site
      • Kyoto、日本、606-8507
        • Research Site
      • Kōtoku、日本、135-8550
        • Research Site
      • Nagoya、日本、464-8681
        • Research Site
      • Nagoya、日本、467-8602
        • Research Site
      • Nishinomiya-shi、日本、663-8501
        • Research Site
      • Osaka、日本、540-0006
        • Research Site
      • Osaka、日本、541-8567
        • Research Site
      • Ota-shi、日本、373-8550
        • Research Site
      • Sapporo、日本、003-0804
        • Research Site
      • Sendai、日本、980-8574
        • Research Site
      • Shimotsuke-shi、日本、329-0498
        • Research Site
      • Shinagawa-ku、日本、142-8666
        • Research Site
      • Shinjuku-ku、日本、162-8655
        • Research Site
      • Suita-shi、日本、565-0871
        • Research Site
      • Takasaki-shi、日本、370-0829
        • Research Site
      • Tsu、日本、514-8507
        • Research Site
      • Tsukuba、日本、305-8576
        • Research Site
      • Yokohama、日本、241-8515
        • Research Site
  • 韓国
      • Busan、韓国、49201
        • Research Site
      • Daegu、韓国、41404
        • Research Site
      • Goyang-si、韓国、10408
        • Research Site
      • Seoul、韓国、03080
        • Research Site
      • Seoul、韓国、03722
        • Research Site
      • Seoul、韓国、05505
        • Research Site
      • Seoul、韓国、06273
        • Research Site
      • Seoul、韓国、06351
        • Research Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～130年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

INCLUSION CRITERIA

Full list of inclusion criteria

  • Pre-/peri-menopausal women or men can be enrolled if amenable to be treated with concomitant, approved LHRH agonists for the duration of the study treatment.
  • De novo Stage 4 disease, or recurrence from early stage disease after at least 24 months of standard adjuvant endocrine therapy. Note that at least 12 months must have elapsed since the patient's last dose of adjuvant AI therapy without disease progression on treatment. Note that a 2-week washout period is required after the last dose of tamoxifen prior to randomisation.
  • Histologically or cytologically documented diagnosis of ER+, HER2-negative breast cancer based on local laboratory results.
  • Previously untreated with any systemic anti-cancer therapy for their locoregionally recurrent or metastatic ER+ disease.
  • Measurable disease as defined per RECIST v.1.1 OR at least one lytic or mixed (lytic + sclerotic) bone lesion with a soft tissue component that can be assessed by CT or MRI.
  • Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Adequate organ and marrow function.
  • Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

INFORMATION FOR TRIAL PARTICIPANTS

Participants can join the trial if they:

  • Have breast cancer that cannot be treated with surgery or radiation
  • Have breast cancer that has already spread into other parts of the body at the time of diagnosis, or has come back after at least 2 years of a standard endocrine treatment
  • Have ER proteins but not overexpression of HER2 protein in their tumors
  • Have never received any type of cancer therapy that affects the whole body for advanced breast cancer
  • Are able to do their daily activities

EXCLUSION CRITERIA

Full list of exclusion criteria

  • Previous neoadjuvant or adjuvant treatment with an AI treatment +/- CDK4/6 inhibitor with disease recurrence while on or within 12 months of completing treatment.
  • Prior exposure to AZD9833, other investigational SERDs/endocrine agents or fulvestrant.
  • Participation in another clinical study with a study treatment or investigational medicinal device administered in the last 4 weeks prior to randomization or concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
  • Advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term and/or impending visceral crisis
  • Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease.
  • Any clinically important and symptomatic heart disease .
  • Currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
  • As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, renal transplant and active bleeding diseases) which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.
  • Any concurrent anti-cancer treatment.
  • Active infection including tuberculosis, HBV and HCV.

INFORMATION FOR TRIAL PARTICIPANTS

Participants cannot join the trial if they:

  • Have uncontrolled cancer that has spread to the brain or the spinal cord
  • Have received certain treatments for cancer in the past but the cancer came back within 1 year
  • Had certain types of tumors in the past, which the study doctors think could come back
  • Are currently taking any treatment for cancer or are taking medications or supplements that affect certain proteins in the body
  • Have any major health problem, infection, or surgery that could make it difficult or dangerous to participate in this trial, such as tuberculosis, HIV, heart problems, or a kidney transplant

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的：AZD9833 + palbociclib

The patients will receive AZD9833 (75 mg, PO, once daily) + palbociclib (PO, once daily, 125 mg for 21 consecutive days followed by 7 days off treatment) + anastrozole placebo (1 mg, PO, once daily)
薬：AZD9833

Dosage formulation: AZD9833 tablets will be administered orally

薬：Anastrozole placebo

Dosage formulation: anastrozole placebo tablets will be administrated orally.

薬：Palbociclib

Dosage formulation: palbociclib tablets/capsules will be administered orally

薬：Luteinizing hormone-releasing hormone (LHRH) agonist

Men (when medically applicable) and pre- or peri-menopausal women are required to receive a monthly LHRH agonist.
アクティブコンパレータ：Anastrozole + palbociclib

The patients will recieve Anastrozole (1 mg, PO, once daily) + palbociclib (PO, once daily, 125 mg for 21 consecutive days followed by 7 days off treatment) + AZD9833 placebo (PO, once daily)
薬：Palbociclib

Dosage formulation: palbociclib tablets/capsules will be administered orally

薬：Luteinizing hormone-releasing hormone (LHRH) agonist

Men (when medically applicable) and pre- or peri-menopausal women are required to receive a monthly LHRH agonist.

薬：Anastrozole

Dosage formulation: Anastrozole tablets will be administered orally.

薬：AZD9833 placebo

Dosage formulation: AZD9833 placebo tablets will be administrated orally.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Progression-free survival (PFS) assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST) version 1.1
時間枠：From randomization until progression per RECIST 1.1 as assessed by the investigator at local site or death due to any cause (up to 5 years)

PFS is defined as the time from randomization to objective disease progression (as assessed by RECIST) or death.
From randomization until progression per RECIST 1.1 as assessed by the investigator at local site or death due to any cause (up to 5 years)

二次結果の測定

結果測定
メジャーの説明
時間枠
Overall survival (OS)
時間枠：From randomization until the date of death due to any cause (up to 8 years)

The OS is defined as the time from randomization to death due to any cause.
From randomization until the date of death due to any cause (up to 8 years)
Second progression-free survival (PFS2)
時間枠：From randomization to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy or death (up to 5 years)

Time to second progression or death (PFS2) will be defined as the time from randomisation to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy or death.
From randomization to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy or death (up to 5 years)
Objective response rate (ORR) assessed by the Investigator as defined by RECIST version 1.1
時間枠：From randomization until a response or in the absence of a response from randomization up until progression, or the last evaluable assessment in the absence of progression (up to 5 years)

ORR is defined as the proportion of patients who have a CR or partial response, as determined by the investigator at local site per RECIST 1.1.
From randomization until a response or in the absence of a response from randomization up until progression, or the last evaluable assessment in the absence of progression (up to 5 years)
Duration of response (DoR) assessed by the Investigator as defined by RECIST version 1.1
時間枠：From the date of first documented response until date of documented progression per RECIST 1.1 as assessed by the investigator at local site or death due to any cause (up to 5 years)

The DoR will be defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression.
From the date of first documented response until date of documented progression per RECIST 1.1 as assessed by the investigator at local site or death due to any cause (up to 5 years)
Time to chemotherapy (TTC)
時間枠：From randomization until the earlier of the start date of chemotherapy or death due to any cause (up to 5 years)

Time to chemotherapy is defined as the time from randomization until the earlier of the start date of chemotherapy or death due to any cause.
From randomization until the earlier of the start date of chemotherapy or death due to any cause (up to 5 years)
Time to first subsequent anti-cancer therapy (TFST)
時間枠：From randomization until the earlier of start date of the first subsequent anti-cancer therapy after discontinuation of randomized treatment, or death due to any cause (up to 5 years)

TFST is defined as time from randomization until the earlier of start date of the first subsequent anti-cancer therapy after discontinuation of randomized treatment, or death due to any cause.
From randomization until the earlier of start date of the first subsequent anti-cancer therapy after discontinuation of randomized treatment, or death due to any cause (up to 5 years)
Clinical benefit rate at 24 weeks (CBR24)
時間枠：At least 23 weeks after randomisation

CBR at 24 weeks is defined as the percentage of participants who have a complete response (CR) or partial response or who have stable disease (SD) per RECIST 1.1 as assessed by the investigator at local site for at least 23 weeks after randomization (to allow for an early assessment within the assessment window).
At least 23 weeks after randomisation
Time to second subsequent therapy (TSST)
時間枠：From randomization until the earlier of start date of the second subsequent anti-cancer therapy after discontinuation of first subsequent treatment, or death due to any cause (up to 5 years)

TSST is defined as time from randomization until the earlier of start date of the second subsequent anti-cancer therapy after discontinuation of first subsequent treatment, or death due to any cause.
From randomization until the earlier of start date of the second subsequent anti-cancer therapy after discontinuation of first subsequent treatment, or death due to any cause (up to 5 years)
Plasma concentration of AZD9833 at specified timepoints
時間枠：on Day 15

To assess the steady state PK of AZD9833 in combination with palbociclib in all participants who receive at least one dose of AZD9833 per the protocol, for whom there are at least one reportable PK concentration.
on Day 15
Change from baseline in EORTC QLQ-C30 scale scores
時間枠：From baseline to 24 weeks post progression (up to approximately 5 years)

Change from baseline in EORTC QLQ-C30 scale scores for each patient at each post-baseline visit. The comparison will include all randomised patients, as randomised, with baseline and at least one post-baseline visit score for the scale score.
From baseline to 24 weeks post progression (up to approximately 5 years)
Change from baseline in EORTC QLQ-BR45 scale scores
時間枠：From baseline to 24 weeks post progression (up to approximately 5 years)

Change from baseline in EORTC QLQ-BR45 scale scores for each patient at each post-baseline visit. The comparison will include all randomised patients, as randomised, with baseline and at least one post-baseline visit score for the scale score.
From baseline to 24 weeks post progression (up to approximately 5 years)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

AstraZeneca

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2021年1月28日

一次修了 (実際)

2026年6月26日

研究の完了 (推定)

2029年2月1日

試験登録日

最初に提出

2020年12月23日

QC基準を満たした最初の提出物

2021年1月12日

最初の投稿 (実際)

2021年1月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月28日

QC基準を満たした最後の更新が送信されました

2026年9月24日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • D8532C00001
  • 2020-002276-12 (EudraCT番号)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD 共有時間枠

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD 共有アクセス基準

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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