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進行性乳がんを有する女性におけるカミゼストラントとアチルモシブリンの併用療法の安全性と忍容性を評価する研究 (SERENA-1b)

2026年9月28日 更新者：AstraZeneca

ER陽性、HER2陰性進行乳癌患者におけるCamizestrantとAtirmociclib併用療法の安全性、薬物動態および予備的有効性を評価する第IIa相オープンラベル試験（SERENA-1b）

A study to investigate camizestrant in combination with atirmociclib in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with a cyclin dependent kinase 4/6 (CDK4/6) inhibitor.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

This is a Phase IIa, sequential assignment, non- randomized, open-label treatment study to determine the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of camizestrant in combination with atirmociclib.

The single-arm study includes:

  • Screening period
  • Atirmociclib single dose period
  • Doublet intervention period
  • Post-treatment follow-up period

研究の種類

介入

入学 (推定)

24

段階

  • フェーズ2

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。

研究連絡先

研究場所

  • アメリカ
    • Missouri
      • St Louis、Missouri、アメリカ、63108
        • 募集
        • Research Site
    • Rhode Island
      • East Providence、Rhode Island、アメリカ、02915
        • 募集
        • Research Site
    • Tennessee
      • Nashville、Tennessee、アメリカ、37203
        • 募集
        • Research Site
  • イギリス
      • Cambridge、イギリス、CB2 0QQ
        • 募集
        • Research Site
      • London、イギリス、EC1M6BQ
        • 募集
        • Research Site
      • Manchester、イギリス、M20 4GJ
        • 募集
        • 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年歳以上 (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

女性

説明

Main Inclusion Criteria:

  • Participants with advanced adenocarcinoma of the breast and must have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease.

  • Metastatic or locoregionally recurrent disease and radiological or objective evidence of progression on or after the last systemic therapy prior to starting investigational medicinal products.

  • Eastern cooperative oncology group (ECOG)/World Health Organization (WHO) performance status 0 to 1, and a minimum life expectancy of 12 weeks.

  • At least one lesion that is measurable and/or non-measurable, as per RECIST 1.1 and that can be accurately assessed at baseline and is suitable for repeated assessment by computed tomography (CT), magnetic resonance imaging (MRI), or plain X-ray, or clinical examination.

  • Menopausal status

    • Pre-menopausal women must start GnRH agonist therapy at least 4 weeks before study treatment and continue throughout the study.
    • Post-menopausal women must meet one of these criteria: bilateral oophorectomy, age ≥60 years, age ≥50 years with ≥12 months amenorrhea and intact uterus without hormonal therapy, or age <60 years with ≥12 months amenorrhea and post-menopausal hormone levels.

  • Histological or cytological confirmation of adenocarcinoma of the breast.

  • Participants of childbearing potential must agree to use one highly effective contraceptive measure.

  • Documentation of ER-positive tumor irrespective of progesterone receptor status.

Main Exclusion Criteria:

  • A participant who has received 2 or more lines of CDK4/6 inhibitors in the advanced disease setting.
  • A participant who has received prior camizestrant or atirmociclib treatment in the advanced disease setting.
  • Patients previously treated with other next generation selective estrogen receptor degrader (SERDs) or other experimental ETs in the advanced disease setting.
  • Patients previously treated with other experimental cyclin-dependent kinase (CDK) inhibitors are not eligible.
  • Inability to swallow oral medications.
  • Any unresolved toxicities of Grade ≥ 2 from prior anti-cancer therapy (with the exception of alopecia).
  • Presence of life-threatening metastatic visceral disease.
  • Any evidence of severe or uncontrolled systemic diseases.
  • Contraindication to or known intolerance/hypersensitivity of/to camizestrant or atirmociclib.

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：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

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

Participants will receive a single dose of atirmociclib on Day -1 followed by combination of camizestrant and atirmociclib from Day 1.
薬：Camizestrant

Camizestrant will be administered orally.

薬：Atirmociclib

Atirmociclib will be administered 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
Number of participants with adverse events (AEs) and serious AEs
時間枠：Up to Post-Treatment Follow up (Day 30 Post Dose)

To investigate the safety and tolerability of camizestrant in combination with atirmociclib.
Up to Post-Treatment Follow up (Day 30 Post Dose)

二次結果の測定

結果測定
メジャーの説明
時間枠
Maximum concentration observed (Cmax)
時間枠：At pre-defined intervals from Day -1 to Day 57

To characterize the PK profile and parameters of atirmociclib.
At pre-defined intervals from Day -1 to Day 57
Area under plasma concentration-time curve from time 0 to infinity (AUCinf)
時間枠：At pre-defined intervals from Day -1 to Day 57

To characterize the PK profile and parameters of atirmociclib.
At pre-defined intervals from Day -1 to Day 57
Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast)
時間枠：At pre-defined intervals from Day -1 to Day 57

To characterize the PK profile and parameters of atirmociclib.
At pre-defined intervals from Day -1 to Day 57
Time to reach maximum (peak) plasma concentration following drug administration (tmax)
時間枠：At pre-defined intervals from Day -1 to Day 57

To characterize the PK profile and parameters of atirmociclib.
At pre-defined intervals from Day -1 to Day 57
Terminal elimination rate constant (λz)
時間枠：At pre-defined intervals from Day -1 to Day 57

To characterize the PK profile and parameters of atirmociclib.
At pre-defined intervals from Day -1 to Day 57
Terminal elimination half-life (t½λz)
時間枠：At pre-defined intervals from Day -1 to Day 57

To characterize the PK profile and parameters of atirmociclib.
At pre-defined intervals from Day -1 to Day 57
Apparent total body clearance (CL/F)
時間枠：At pre-defined intervals from Day -1 to Day 57

To characterize the PK profile and parameters of atirmociclib.
At pre-defined intervals from Day -1 to Day 57
Apparent volume of distribution at steady state (Vss/F)
時間枠：At pre-defined intervals from Day -1 to Day 57

To characterize the PK profile and parameters of atirmociclib.
At pre-defined intervals from Day -1 to Day 57
Apparent volume of distribution based on the terminal phase (Vz/F)
時間枠：At pre-defined intervals from Day -1 to Day 57

To characterize the PK profile and parameters of atirmociclib.
At pre-defined intervals from Day -1 to Day 57
Maximum concentration observed at steady state (Cssmax)
時間枠：At pre-defined intervals from Day -1 to Day 57

To characterise the PK profile and parameters of atirmociclib and camizestrant after administration in combination with each other.
At pre-defined intervals from Day -1 to Day 57
Area under the curve from 0 to the end of dosing interval (AUC0-tau)
時間枠：At pre-defined intervals from Day -1 to Day 57

To characterise the PK profile and parameters of atirmociclib and camizestrant after administration in combination with each other.
At pre-defined intervals from Day -1 to Day 57
Area under the curve from 0 to the end of dosing interval at steady state (AUCss0-tau)
時間枠：At pre-defined intervals from Day -1 to Day 57

To characterise the PK profile and parameters of atirmociclib and camizestrant after administration in combination with each other.
At pre-defined intervals from Day -1 to Day 57
Time to reach maximum plasma concentration at steady state (tssmax)
時間枠：At pre-defined intervals from Day -1 to Day 57

To characterise the PK profile and parameters of atirmociclib and camizestrant after administration in combination with each other.
At pre-defined intervals from Day -1 to Day 57
Objective Response Rate (ORR)
時間枠：Up to 2 years

To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib.
Up to 2 years
Duration of Response (DOR)
時間枠：Up to 2 years

To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib.
Up to 2 years
Clinical Benefit Rate at 24 Weeks (CBR24)
時間枠：At 24 weeks

To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib.
At 24 weeks
Percentage change in tumor size
時間枠：Up to 2 years

To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib.
Up to 2 years
Progression Free Survival (PFS)
時間枠：Up to 2 years

To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib.
Up to 2 years
Progression-free survival landmark 6 months (PFSLM6m)
時間枠：At 6 months

To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib.
At 6 months
Progression-free survival landmark 12 months (PFSLM12m)
時間枠：At 12 months

To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib.
At 12 months

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

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)

2026年5月6日

一次修了 (推定)

2027年12月28日

研究の完了 (推定)

2027年12月28日

試験登録日

最初に提出

2026年2月16日

QC基準を満たした最初の提出物

2026年2月16日

最初の投稿 (実際)

2026年2月23日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月29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28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

  • D853CC00001

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 Vivli.org. All requests 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 PhRMA 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 anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

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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