A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer (SERAFA-1)
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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：AstraZeneca Clinical Study Information Center
- 電話番号：1-877-240-9479
- メール：information.center@astrazeneca.com
研究場所
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California
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Duarte、California、アメリカ、91010
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Palo Alto、California、アメリカ、94304
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Georgia
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Marietta、Georgia、アメリカ、30060
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Illinois
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Evanston、Illinois、アメリカ、60201
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Kentucky
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Edgewood、Kentucky、アメリカ、41017
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Louisville、Kentucky、アメリカ、40202
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Nevada
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Reno、Nevada、アメリカ、89502
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South Dakota
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Sioux Falls、South Dakota、アメリカ、57105
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Tennessee
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Nashville、Tennessee、アメリカ、37204
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Texas
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Fort Worth、Texas、アメリカ、76104
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Kingwood、Texas、アメリカ、77339
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Virginia
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Midlothian、Virginia、アメリカ、23114
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Aviano、イタリア、33081
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Bergamo、イタリア、24127
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Genova、イタリア、16132
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Milan、イタリア、20127
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Naples、イタリア、80131
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Basel、スイス、4031
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Liestal、スイス、CH-4410
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Rennaz、スイス、1847
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Badajoz、スペイン、06080
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Badalona、スペイン、08916
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Barcelona、スペイン、08041
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Donostia / San Sebastian、スペイン、20014
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Huelva、スペイン、21005
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Jaén、スペイン、23007
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Las Palmas de Gran Canaria、スペイン、35016
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Majadahonda、スペイン、28222
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Murcia、スペイン、30008
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Málaga、スペイン、29010
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Pontevedra、スペイン、36312
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Pozuelo de Alarcón、スペイン、28223
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Santander、スペイン、39008
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Toledo、スペイン、45007
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Zaragoza、スペイン、50009
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Berlin、ドイツ、13125
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Düsseldorf、ドイツ、40235
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Freiburg im Breisgau、ドイツ、79110
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Mönchengladbach、ドイツ、41061
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München、ドイツ、81675
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Paderborn、ドイツ、33098
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Trier、ドイツ、54290
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Velbert、ドイツ、42551
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Angers、フランス、49933
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Bayonne、フランス、64109
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Bobigny、フランス、93000
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Caen、フランス、14000
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Chambray-lès-Tours、フランス、37170
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Grenoble、フランス、38043
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Montpellier、フランス、34070
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Nancy、フランス、54100
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Nîmes、フランス、30029
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Pierre-Bénite、フランス、69310
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Valenciennes、フランス、59300
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Vandœuvre-lès-Nancy、フランス、54519
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Villejuif、フランス、94805
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Gdansk、ポーランド、80-952
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Konin、ポーランド、62-500
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Krakow、ポーランド、30-688
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Lodz、ポーランド、90-302
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Lublin、ポーランド、20-090
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Poznan、ポーランド、61-485
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Przemyśl、ポーランド、37-700
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Wroclaw、ポーランド、53-413
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Cheonan-si、韓国、31151
- Research Site
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Daegu、韓国、42415
- Research Site
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Goyang-si、韓国、10408
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Hwasun-eup、韓国、58128
- Research Site
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Incheon、韓国、405-760
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Seongbuk-Gu、韓国、02841
- Research Site
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Seongnam-si、韓国、13620
- Research Site
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Seongnam-si、韓国、13520
- Research Site
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Seoul、韓国、03080
- Research Site
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Seoul、韓国、06273
- Research Site
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Seoul、韓国、06351
- Research Site
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Seoul、韓国、06591
- Research Site
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Seoul、韓国、3722
- Research Site
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Seoul、韓国、07985
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Songpa-gu、韓国、05505
- Research Site
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Suwon、韓国、16499
- Research Site
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Capable of giving signed informed consent.
Female or male, must be ≥ 18 years or as per locally allowed age limit for screening.
Type of Participant and Disease Characteristics
- 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.
- Previously untreated with any systemic anti-cancer therapy for their locoregionally recurrent or metastatic ER+ disease.
- 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.
- ECOG performance status of 0 or 1.
- Adequate organ and marrow function. Sex and Contraceptive/Barrier Requirements
- 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:
- Participants who are not clinically indicated for endocrine therapy in combination with the CDK4/6 inhibitor ribociclib.
- No evidence of advanced inoperable disease, or bone only disease with sclerotic/osteoblastic bone lesions only per standard of care imaging.
- Have advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term, and/or pulmonary lymphangitis.
- Persistent treatment-induced non-haematological toxicities (CTCAE Grade > 2).
- Known active infection including tuberculosis HBV and HCV.
- Known to have tested positive for HIV. Participants with HIV may be enrolled if they fulfil the criteria recommended by FDA and ASCO guidelines.
- Any clinically important abnormalities in heart conduction patterns; participants with pacemakers or medically controlled atrial fibrillation are not excluded.
- Ongoing symptomatic hypotension.
- Pregnant or lactating women or patients not willing to use highly effective contraception as defined in the protocol.
研究計画
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：非ランダム化
- 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 |
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実験的：Camizestrant and Ribociclib
Patients will receive the standard dose of camizestrant and ribociclib once daily as oral tablets
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Patients will receive the standard dose of camizestrant once daily as oral tablets
他の名前：
Patients will receive the standard dose of ribociclib once daily as oral tablets
他の名前：
|
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 |
|---|---|---|
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Efficacy of camizestrant and ribociclib by time to next treatment (TTNT)
時間枠：Following first dose of study treatment until earliest of subsequent therapy, death and 2 years after first dose of study treatment.
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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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Efficacy of camizestrant and ribociclib by time to discontinuation (TTD)
時間枠：Following first dose of study treatment until earliest of discontinuation of camizestrant, death and 2 years after first dose of study treatment
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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
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Efficacy of camizestrant and ribociclib by progression free survival (PFS)
時間枠：Following first dose of study treatment until earliest of death, disease progression, and 2 years after first dose of study treatment.
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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.
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CTCAE grade ≥ 3 associated with camizestrant and ribociclib within first 6 months of study treatment
時間枠：Following first dose of study treatment until 6 months later
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Incidence of Grade >=3 CTCAEs associated with Camizestrant and/or Ribo within first 6 months of receiving study treatment.
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Following first dose of study treatment until 6 months later
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協力者と研究者
スポンサー
協力者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- D8532C00008
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?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
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
米国FDA規制機器製品の研究
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