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A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer (SERAFA-1)

2026年9月4日 更新者：AstraZeneca

SERAFA-1: A Single Arm, Open Label, Multicentre, Phase IIIb Study Of Camizestrant Plus Ribociclib in 1st Line Treatment of ER Positive, HER2-negative Advanced Breast Cancer Patients

The purpose of this study is to investigate the efficacy, safety, and tolerability of camizestrant in combination with ribociclib in patients with ER+ HER2- BC who have not received any other systemic treatment for advanced disease. Participants will be treated within the trial until they discontinue the study treatment for any reason.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This global, multicenter, Phase IIIb, single-arm study will evaluate the efficacy, safety, and tolerability of camizestrant combined with ribociclib in patients with ER+ HER2- advanced breast cancer who have not previously received systemic therapy for advanced disease.

Approximately 150 participants will be enrolled, and all enrolled participants will receive standard daily oral doses of camizestrant 75 mg and ribociclib 600 mg until treatment discontinuation.

研究类型

介入性

注册 (估计的)

150

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 德国
      • Berlin、德国、13125
        • 尚未招聘
        • Research Site
      • Düsseldorf、德国、40235
        • 尚未招聘
        • Research Site
      • Erlangen、德国、91054
        • 尚未招聘
        • Research Site
      • Freiburg im Breisgau、德国、79110
        • 尚未招聘
        • Research Site
      • Mönchengladbach、德国、41061
        • 尚未招聘
        • Research Site
      • München、德国、81675
        • 尚未招聘
        • Research Site
      • Paderborn、德国、33098
        • 尚未招聘
        • Research Site
      • Trier、德国、54290
        • 尚未招聘
        • Research Site
      • Velbert、德国、42551
        • 尚未招聘
        • Research Site
  • 意大利
      • Aviano、意大利、33081
        • 尚未招聘
        • Research Site
      • Bergamo、意大利、24127
        • 尚未招聘
        • Research Site
      • Genova、意大利、16132
        • 尚未招聘
        • Research Site
      • Milan、意大利、20127
        • 尚未招聘
        • Research Site
      • Naples、意大利、80131
        • 尚未招聘
        • Research Site
  • 法国
      • Angers、法国、49933
        • 尚未招聘
        • Research Site
      • Bayonne、法国、64109
        • 尚未招聘
        • Research Site
      • Bobigny、法国、93000
        • 尚未招聘
        • Research Site
      • Caen、法国、14000
        • 尚未招聘
        • Research Site
      • Chambray-lès-Tours、法国、37170
        • 尚未招聘
        • Research Site
      • Grenoble、法国、38043
        • 尚未招聘
        • Research Site
      • Montpellier、法国、34070
        • 尚未招聘
        • Research Site
      • Nancy、法国、54100
        • 尚未招聘
        • Research Site
      • Nîmes、法国、30029
        • 尚未招聘
        • Research Site
      • Paris、法国、75014
        • 尚未招聘
        • Research Site
      • Pierre-Bénite、法国、69310
        • 尚未招聘
        • Research Site
      • Valenciennes、法国、59300
        • 尚未招聘
        • Research Site
      • Vandœuvre-lès-Nancy、法国、54519
        • 尚未招聘
        • Research Site
      • Villejuif、法国、94805
        • 尚未招聘
        • Research Site
  • 波兰
      • Gdansk、波兰、80-952
        • 尚未招聘
        • Research Site
      • Konin、波兰、62-500
        • 尚未招聘
        • Research Site
      • Krakow、波兰、30-688
        • 尚未招聘
        • Research Site
      • Lodz、波兰、90-302
        • 尚未招聘
        • Research Site
      • Lublin、波兰、20-090
        • 尚未招聘
        • Research Site
      • Poznan、波兰、61-485
        • 尚未招聘
        • Research Site
      • Przemyśl、波兰、37-700
        • 暂停
        • Research Site
      • Wroclaw、波兰、53-413
        • 尚未招聘
        • Research Site
  • 瑞士
      • Basel、瑞士、4031
        • 尚未招聘
        • Research Site
      • Liestal、瑞士、CH-4410
        • 尚未招聘
        • Research Site
      • Rennaz、瑞士、1847
        • 尚未招聘
        • Research Site
  • 美国
    • California
      • Duarte、California、美国、91010
        • 尚未招聘
        • Research Site
      • Palo Alto、California、美国、94304
        • 尚未招聘
        • Research Site
    • Georgia
      • Marietta、Georgia、美国、30060
        • 招聘中
        • Research Site
    • Illinois
      • Evanston、Illinois、美国、60201
        • 尚未招聘
        • Research Site
    • Kentucky
      • Edgewood、Kentucky、美国、41017
        • 尚未招聘
        • Research Site
      • Louisville、Kentucky、美国、40202
        • 尚未招聘
        • Research Site
    • Nevada
      • Reno、Nevada、美国、89502
        • 尚未招聘
        • Research Site
    • South Dakota
      • Sioux Falls、South Dakota、美国、57105
        • 尚未招聘
        • Research Site
    • Tennessee
      • Nashville、Tennessee、美国、37204
        • 尚未招聘
        • Research Site
    • Texas
      • Fort Worth、Texas、美国、76104
        • 尚未招聘
        • Research Site
      • Kingwood、Texas、美国、77339
        • 招聘中
        • Research Site
    • Virginia
      • Midlothian、Virginia、美国、23114
        • 尚未招聘
        • Research Site
  • 西班牙
      • Badajoz、西班牙、06080
        • 尚未招聘
        • Research Site
      • Badalona、西班牙、08916
        • 尚未招聘
        • Research Site
      • Barcelona、西班牙、08041
        • 尚未招聘
        • Research Site
      • Burgos、西班牙、9006
        • 尚未招聘
        • Research Site
      • Donostia / San Sebastian、西班牙、20014
        • 尚未招聘
        • Research Site
      • Huelva、西班牙、21005
        • 尚未招聘
        • Research Site
      • Jaén、西班牙、23007
        • 尚未招聘
        • Research Site
      • Las Palmas de Gran Canaria、西班牙、35016
        • 尚未招聘
        • Research Site
      • Majadahonda、西班牙、28222
        • 尚未招聘
        • Research Site
      • Murcia、西班牙、30008
        • 尚未招聘
        • Research Site
      • Málaga、西班牙、29010
        • 尚未招聘
        • Research Site
      • Oviedo、西班牙、33011
        • 尚未招聘
        • Research Site
      • Palma de Mallorca、西班牙、07198
        • 尚未招聘
        • Research Site
      • Pontevedra、西班牙、36312
        • 尚未招聘
        • Research Site
      • Pozuelo de Alarcón、西班牙、28223
        • 尚未招聘
        • Research Site
      • Santander、西班牙、39008
        • 尚未招聘
        • Research Site
      • Toledo、西班牙、45007
        • 尚未招聘
        • Research Site
      • Zaragoza、西班牙、50009
        • 尚未招聘
        • Research Site
  • 阿拉伯联合酋长国
      • Abu Dhabi、阿拉伯联合酋长国、11241
        • 尚未招聘
        • Research Site
      • Al Ain City、阿拉伯联合酋长国、00000
        • 尚未招聘
        • Research Site
      • Dubai、阿拉伯联合酋长国、505004
        • 尚未招聘
        • Research Site
      • Mohammed Bin Zayed City、阿拉伯联合酋长国、92510
        • 尚未招聘
        • Research Site
  • 韩国
      • Cheonan-si、韩国、31151
        • 尚未招聘
        • Research Site
      • Daegu、韩国、42415
        • 暂停
        • Research Site
      • Goyang-si、韩国、10408
        • 尚未招聘
        • Research Site
      • Hwasun-eup、韩国、58128
        • 尚未招聘
        • Research Site
      • Incheon、韩国、405-760
        • 尚未招聘
        • Research Site
      • Seongbuk-Gu、韩国、02841
        • 尚未招聘
        • Research Site
      • Seongnam-si、韩国、13620
        • 尚未招聘
        • Research Site
      • Seongnam-si、韩国、13520
        • 尚未招聘
        • Research Site
      • Seoul、韩国、3722
        • 尚未招聘
        • Research Site
      • Seoul、韩国、03080
        • 尚未招聘
        • Research Site
      • Seoul、韩国、06591
        • 尚未招聘
        • Research Site
      • Seoul、韩国、06273
        • 尚未招聘
        • Research Site
      • Seoul、韩国、06351
        • 尚未招聘
        • Research Site
      • Seoul、韩国、07985
        • 尚未招聘
        • Research Site
      • Songpa-gu、韩国、05505
        • 尚未招聘
        • Research Site
      • Suwon、韩国、16499
        • 暂停
        • Research Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Capable of giving signed informed consent.

  2. Female or male, must be ≥ 18 years or as per locally allowed age limit for screening.

    Type of Participant and Disease Characteristics

  3. Histologically or cytologically documented diagnosis of ER+, HER2- BC based on local laboratory results and who are not amenable to resection or radiation therapy with curative intent.
  4. Previously untreated with any systemic anti-cancer therapy for their locoregionally recurrent or metastatic ER+ disease.
  5. De novo Stage 4 disease, or recurrence from early CD stage breast cancer after having received 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.
  6. ECOG performance status of 0 or 1.
  7. Adequate organ and marrow function. Sex and Contraceptive/Barrier Requirements
  8. For those female or male patients who are not abstinent (in line with their preferred and usual lifestyle choice), and intend to be heterosexually active with a partner:

Female patients must be using highly effective contraceptive measures from the time of screening until 4 weeks after discontinuation of study treatment, and must have a negative serum pregnancy test before first dose of any study treatment if they are of childbearing potential; or must have evidence of nonchild-bearing potential by fulfilling one of the following criteria at screening:

(a) Post-menopausal, defined as women with cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause: (i) Age ≥ 60 years (ii) Age < 60 years with serum estradiol and FSH level within the laboratory's reference range for post-menopausal females (iii) Previous bilateral surgical oophorectomy (iv) Medically confirmed ovarian failure OR (b) Pre/peri-menopausal, ie, not meeting the criteria for being post-menopausal.

(i) Pre-/peri-menopausal women can be enrolled if amenable to be treated with monthly LHRH agonists (goserelin or leuprorelin [also known as leuprolide]). Patients must have concomitant treatment with LHRH agonists (goserelin or leuprorelin [leuprolide]) before or on the same day as the first dose of study treatment - and must be willing to continue on it for the duration of the study.

Non sterilised male partners of a patient who is a woman of childbearing potential must use a male condom plus spermicide (condom alone in countries where spermicides are not approved) throughout this period.

Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile or using an acceptable method of contraception from the time of screening throughout the total duration of the programme and the drug washout period to prevent pregnancy in a partner. Male participants must not donate or bank sperm during this same time period.

Male patients can be enrolled if amenable to be treated with monthly LHRH agonists (goserelin or leuprorelin [also known as leuprolide]) unless the patients have clear orchiectomy medical history. Willingness to use 2 non-hormonal based methods of contraception throughout the study.

Exclusion Criteria:

  1. Participants who are not clinically indicated for endocrine therapy in combination with the CDK4/6 inhibitor ribociclib.
  2. No evidence of advanced inoperable disease, or bone only disease with sclerotic/osteoblastic bone lesions only per standard of care imaging.
  3. Have advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term, and/or pulmonary lymphangitis.
  4. Persistent treatment-induced non-haematological toxicities (CTCAE Grade > 2).
  5. Known active infection including tuberculosis HBV and HCV.
  6. Known to have tested positive for HIV. Participants with HIV may be enrolled if they fulfil the criteria recommended by FDA and ASCO guidelines.
  7. Any clinically important abnormalities in heart conduction patterns; participants with pacemakers or medically controlled atrial fibrillation are not excluded.
  8. Ongoing symptomatic hypotension.
  9. Pregnant or lactating women or patients not willing to use highly effective contraception as defined in the protocol.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Camizestrant and Ribociclib
Patients will receive the standard dose of camizestrant and ribociclib once daily as oral tablets
药品：Camizestrant
Patients will receive the standard dose of camizestrant once daily as oral tablets
其他名称：
  • AZD9833
药品：Ribociclib
Patients will receive the standard dose of ribociclib once daily as oral tablets
其他名称：
  • KISQALI®

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Efficacy of camizestrant and ribociclib by time to next treatment (TTNT)
大体时间：Following first dose of study treatment until earliest of subsequent therapy, death and 2 years after first dose of study treatment.

TTNT is defined as time from the date of the first administration of study treatment to the earliest start date of subsequent anti-cancer medication or death.

The primary measure of interest is the TTNT event-free rate at 2 years.
Following first dose of study treatment until earliest of subsequent therapy, death and 2 years after first dose of study treatment.

次要结果测量

结果测量
措施说明
大体时间
Efficacy of camizestrant and ribociclib by time to discontinuation (TTD)
大体时间：Following first dose of study treatment until earliest of discontinuation of camizestrant, death and 2 years after first dose of study treatment

TTD is defined as time from the date of the first administration of study treatment to the earliest date of camizestrant treatment discontinuation or death.

The primary measure of interest is the TTD event-free rate at 2 years.
Following first dose of study treatment until earliest of discontinuation of camizestrant, death and 2 years after first dose of study treatment
Efficacy of camizestrant and ribociclib by progression free survival (PFS)
大体时间：Following first dose of study treatment until earliest of death, disease progression, and 2 years after first dose of study treatment.

PFS is defined as time from first dose of study treatment until progression per RECIST 1.1 as assessed by investigator or death due to any cause.

The primary measures of interest are the PFS event-free rates at 1 and 2 years.
Following first dose of study treatment until earliest of death, disease progression, and 2 years after first dose of study treatment.
CTCAE grade ≥ 3 associated with camizestrant and ribociclib within first 6 months of study treatment
大体时间：Following first dose of study treatment until 6 months later
Incidence of Grade >=3 CTCAEs associated with Camizestrant and/or Ribo within first 6 months of receiving study treatment.
Following first dose of study treatment until 6 months later

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

AstraZeneca

合作者

ICON plc

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月15日

初级完成 (估计的)

2029年2月28日

研究完成 (估计的)

2029年2月28日

研究注册日期

首次提交

2026年5月12日

首先提交符合 QC 标准的

2026年6月9日

首次发布 (实际的)

2026年6月15日

研究记录更新

最后更新发布 (实际的)

2026年9月8日

上次提交的符合 QC 标准的更新

2026年9月4日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • D8532C00008

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD 共享时间框架

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 共享访问标准

When a request has been approved AstraZeneca will provide access to the de-identified 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.

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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