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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 junio de 2026 actualizado 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Estimado)

150

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Alemania
      • Berlin, Alemania, 13125
        • Research Site
      • Düsseldorf, Alemania, 40235
        • Research Site
      • Freiburg im Breisgau, Alemania, 79110
        • Research Site
      • Mönchengladbach, Alemania, 41061
        • Research Site
      • München, Alemania, 81675
        • Research Site
      • Paderborn, Alemania, 33098
        • Research Site
      • Trier, Alemania, 54290
        • Research Site
      • Velbert, Alemania, 42551
        • Research Site
  • Corea del Sur
      • Cheonan-si, Corea del Sur, 31151
        • Research Site
      • Daegu, Corea del Sur, 42415
        • Research Site
      • Goyang-si, Corea del Sur, 10408
        • Research Site
      • Hwasun-eup, Corea del Sur, 58128
        • Research Site
      • Incheon, Corea del Sur, 405-760
        • Research Site
      • Seongbuk-Gu, Corea del Sur, 02841
        • Research Site
      • Seongnam-si, Corea del Sur, 13620
        • Research Site
      • Seongnam-si, Corea del Sur, 13520
        • Research Site
      • Seoul, Corea del Sur, 03080
        • Research Site
      • Seoul, Corea del Sur, 06273
        • Research Site
      • Seoul, Corea del Sur, 06351
        • Research Site
      • Seoul, Corea del Sur, 06591
        • Research Site
      • Seoul, Corea del Sur, 3722
        • Research Site
      • Seoul, Corea del Sur, 07985
        • Research Site
      • Songpa-gu, Corea del Sur, 05505
        • Research Site
      • Suwon, Corea del Sur, 16499
        • Research Site
  • España
      • Badajoz, España, 06080
        • Research Site
      • Badalona, España, 08916
        • Research Site
      • Barcelona, España, 08041
        • Research Site
      • Donostia / San Sebastian, España, 20014
        • Research Site
      • Huelva, España, 21005
        • Research Site
      • Jaén, España, 23007
        • Research Site
      • Las Palmas de Gran Canaria, España, 35016
        • Research Site
      • Majadahonda, España, 28222
        • Research Site
      • Murcia, España, 30008
        • Research Site
      • Málaga, España, 29010
        • Research Site
      • Pontevedra, España, 36312
        • Research Site
      • Pozuelo de Alarcón, España, 28223
        • Research Site
      • Santander, España, 39008
        • Research Site
      • Toledo, España, 45007
        • Research Site
      • Zaragoza, España, 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
  • Francia
      • Angers, Francia, 49933
        • Research Site
      • Bayonne, Francia, 64109
        • Research Site
      • Bobigny, Francia, 93000
        • Research Site
      • Caen, Francia, 14000
        • Research Site
      • Chambray-lès-Tours, Francia, 37170
        • Research Site
      • Grenoble, Francia, 38043
        • Research Site
      • Montpellier, Francia, 34070
        • Research Site
      • Nancy, Francia, 54100
        • Research Site
      • Nîmes, Francia, 30029
        • Research Site
      • Pierre-Bénite, Francia, 69310
        • Research Site
      • Valenciennes, Francia, 59300
        • Research Site
      • Vandœuvre-lès-Nancy, Francia, 54519
        • Research Site
      • Villejuif, Francia, 94805
        • Research Site
  • Italia
      • Aviano, Italia, 33081
        • Research Site
      • Bergamo, Italia, 24127
        • Research Site
      • Genova, Italia, 16132
        • Research Site
      • Milan, Italia, 20127
        • Research Site
      • Naples, Italia, 80131
        • Research Site
  • Polonia
      • Gdansk, Polonia, 80-952
        • Research Site
      • Konin, Polonia, 62-500
        • Research Site
      • Krakow, Polonia, 30-688
        • Research Site
      • Lodz, Polonia, 90-302
        • Research Site
      • Lublin, Polonia, 20-090
        • Research Site
      • Poznan, Polonia, 61-485
        • Research Site
      • Przemyśl, Polonia, 37-700
        • Research Site
      • Wroclaw, Polonia, 53-413
        • Research Site
  • Suiza
      • Basel, Suiza, 4031
        • Research Site
      • Liestal, Suiza, CH-4410
        • Research Site
      • Rennaz, Suiza, 1847
        • Research Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Camizestrant and Ribociclib
Patients will receive the standard dose of camizestrant and ribociclib once daily as oral tablets
Droga: Camizestrant
Patients will receive the standard dose of camizestrant once daily as oral tablets
Otros nombres:
  • AZD9833
Droga: Ribociclib
Patients will receive the standard dose of ribociclib once daily as oral tablets
Otros nombres:
  • KISQALI®

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Efficacy of camizestrant and ribociclib by time to next treatment (TTNT)
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Efficacy of camizestrant and ribociclib by time to discontinuation (TTD)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

AstraZeneca

Colaboradores

ICON plc

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

26 de mayo de 2026

Finalización primaria (Estimado)

20 de abril de 2028

Finalización del estudio (Estimado)

10 de abril de 2034

Fechas de registro del estudio

Enviado por primera vez

12 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de junio de 2026

Publicado por primera vez (Actual)

15 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de junio de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • D8532C00008

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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

Marco de tiempo para compartir 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.

Criterios de acceso compartido de 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 información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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