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

9 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

150

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Alemanha
      • Berlin, Alemanha, 13125
        • Research Site
      • Düsseldorf, Alemanha, 40235
        • Research Site
      • Freiburg im Breisgau, Alemanha, 79110
        • Research Site
      • Mönchengladbach, Alemanha, 41061
        • Research Site
      • München, Alemanha, 81675
        • Research Site
      • Paderborn, Alemanha, 33098
        • Research Site
      • Trier, Alemanha, 54290
        • Research Site
      • Velbert, Alemanha, 42551
        • Research Site
  • Coréia do Sul
      • Cheonan-si, Coréia do Sul, 31151
        • Research Site
      • Daegu, Coréia do Sul, 42415
        • Research Site
      • Goyang-si, Coréia do Sul, 10408
        • Research Site
      • Hwasun-eup, Coréia do Sul, 58128
        • Research Site
      • Incheon, Coréia do Sul, 405-760
        • Research Site
      • Seongbuk-Gu, Coréia do Sul, 02841
        • Research Site
      • Seongnam-si, Coréia do Sul, 13620
        • Research Site
      • Seongnam-si, Coréia do Sul, 13520
        • Research Site
      • Seoul, Coréia do Sul, 03080
        • Research Site
      • Seoul, Coréia do Sul, 06273
        • Research Site
      • Seoul, Coréia do Sul, 06351
        • Research Site
      • Seoul, Coréia do Sul, 06591
        • Research Site
      • Seoul, Coréia do Sul, 3722
        • Research Site
      • Seoul, Coréia do Sul, 07985
        • Research Site
      • Songpa-gu, Coréia do Sul, 05505
        • Research Site
      • Suwon, Coréia do Sul, 16499
        • Research Site
  • Espanha
      • Badajoz, Espanha, 06080
        • Research Site
      • Badalona, Espanha, 08916
        • Research Site
      • Barcelona, Espanha, 08041
        • Research Site
      • Donostia / San Sebastian, Espanha, 20014
        • Research Site
      • Huelva, Espanha, 21005
        • Research Site
      • Jaén, Espanha, 23007
        • Research Site
      • Las Palmas de Gran Canaria, Espanha, 35016
        • Research Site
      • Majadahonda, Espanha, 28222
        • Research Site
      • Murcia, Espanha, 30008
        • Research Site
      • Málaga, Espanha, 29010
        • Research Site
      • Pontevedra, Espanha, 36312
        • Research Site
      • Pozuelo de Alarcón, Espanha, 28223
        • Research Site
      • Santander, Espanha, 39008
        • Research Site
      • Toledo, Espanha, 45007
        • Research Site
      • Zaragoza, Espanha, 50009
        • Research Site
  • Estados Unidos
    • California
      • Duarte, California, Estados Unidos, 91010
        • Research Site
      • Palo Alto, California, Estados Unidos, 94304
        • Research Site
    • Georgia
      • Marietta, Georgia, Estados Unidos, 30060
        • Research Site
    • Illinois
      • Evanston, Illinois, Estados Unidos, 60201
        • Research Site
    • Kentucky
      • Edgewood, Kentucky, Estados Unidos, 41017
        • Research Site
      • Louisville, Kentucky, Estados Unidos, 40202
        • Research Site
    • Nevada
      • Reno, Nevada, Estados Unidos, 89502
        • Research Site
    • South Dakota
      • Sioux Falls, South Dakota, Estados Unidos, 57105
        • Research Site
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37204
        • Research Site
    • Texas
      • Fort Worth, Texas, Estados Unidos, 76104
        • Research Site
      • Kingwood, Texas, Estados Unidos, 77339
        • Research Site
    • Virginia
      • Midlothian, Virginia, Estados Unidos, 23114
        • Research Site
  • França
      • Angers, França, 49933
        • Research Site
      • Bayonne, França, 64109
        • Research Site
      • Bobigny, França, 93000
        • Research Site
      • Caen, França, 14000
        • Research Site
      • Chambray-lès-Tours, França, 37170
        • Research Site
      • Grenoble, França, 38043
        • Research Site
      • Montpellier, França, 34070
        • Research Site
      • Nancy, França, 54100
        • Research Site
      • Nîmes, França, 30029
        • Research Site
      • Pierre-Bénite, França, 69310
        • Research Site
      • Valenciennes, França, 59300
        • Research Site
      • Vandœuvre-lès-Nancy, França, 54519
        • Research Site
      • Villejuif, França, 94805
        • Research Site
  • Itália
      • Aviano, Itália, 33081
        • Research Site
      • Bergamo, Itália, 24127
        • Research Site
      • Genova, Itália, 16132
        • Research Site
      • Milan, Itália, 20127
        • Research Site
      • Naples, Itália, 80131
        • Research Site
  • Polônia
      • Gdansk, Polônia, 80-952
        • Research Site
      • Konin, Polônia, 62-500
        • Research Site
      • Krakow, Polônia, 30-688
        • Research Site
      • Lodz, Polônia, 90-302
        • Research Site
      • Lublin, Polônia, 20-090
        • Research Site
      • Poznan, Polônia, 61-485
        • Research Site
      • Przemyśl, Polônia, 37-700
        • Research Site
      • Wroclaw, Polônia, 53-413
        • Research Site
  • Suíça
      • Basel, Suíça, 4031
        • Research Site
      • Liestal, Suíça, CH-4410
        • Research Site
      • Rennaz, Suíça, 1847
        • Research Site

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Camizestrant and Ribociclib
Patients will receive the standard dose of camizestrant and ribociclib once daily as oral tablets
Medicamento: Camizestrant
Patients will receive the standard dose of camizestrant once daily as oral tablets
Outros nomes:
  • AZD9833
Medicamento: Ribociclib
Patients will receive the standard dose of ribociclib once daily as oral tablets
Outros nomes:
  • KISQALI®

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Efficacy of camizestrant and ribociclib by time to next treatment (TTNT)
Prazo: 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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Efficacy of camizestrant and ribociclib by time to discontinuation (TTD)
Prazo: 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)
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

AstraZeneca

Colaboradores

ICON plc

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

26 de maio de 2026

Conclusão Primária (Estimado)

20 de abril de 2028

Conclusão do estudo (Estimado)

10 de abril de 2034

Datas de inscrição no estudo

Enviado pela primeira vez

12 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de junho de 2026

Primeira postagem (Real)

15 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

15 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de junho de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • D8532C00008

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

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

Prazo de Compartilhamento de IPD

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.

Critérios de acesso de compartilhamento IPD

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.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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