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

9 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

150

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Corea del Sud
      • Cheonan-si, Corea del Sud, 31151
        • Research Site
      • Daegu, Corea del Sud, 42415
        • Research Site
      • Goyang-si, Corea del Sud, 10408
        • Research Site
      • Hwasun-eup, Corea del Sud, 58128
        • Research Site
      • Incheon, Corea del Sud, 405-760
        • Research Site
      • Seongbuk-Gu, Corea del Sud, 02841
        • Research Site
      • Seongnam-si, Corea del Sud, 13620
        • Research Site
      • Seongnam-si, Corea del Sud, 13520
        • Research Site
      • Seoul, Corea del Sud, 03080
        • Research Site
      • Seoul, Corea del Sud, 06273
        • Research Site
      • Seoul, Corea del Sud, 06351
        • Research Site
      • Seoul, Corea del Sud, 06591
        • Research Site
      • Seoul, Corea del Sud, 3722
        • Research Site
      • Seoul, Corea del Sud, 07985
        • Research Site
      • Songpa-gu, Corea del Sud, 05505
        • Research Site
      • Suwon, Corea del Sud, 16499
        • 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
  • Germania
      • Berlin, Germania, 13125
        • Research Site
      • Düsseldorf, Germania, 40235
        • Research Site
      • Freiburg im Breisgau, Germania, 79110
        • Research Site
      • Mönchengladbach, Germania, 41061
        • Research Site
      • München, Germania, 81675
        • Research Site
      • Paderborn, Germania, 33098
        • Research Site
      • Trier, Germania, 54290
        • Research Site
      • Velbert, Germania, 42551
        • 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
  • Spagna
      • Badajoz, Spagna, 06080
        • Research Site
      • Badalona, Spagna, 08916
        • Research Site
      • Barcelona, Spagna, 08041
        • Research Site
      • Donostia / San Sebastian, Spagna, 20014
        • Research Site
      • Huelva, Spagna, 21005
        • Research Site
      • Jaén, Spagna, 23007
        • Research Site
      • Las Palmas de Gran Canaria, Spagna, 35016
        • Research Site
      • Majadahonda, Spagna, 28222
        • Research Site
      • Murcia, Spagna, 30008
        • Research Site
      • Málaga, Spagna, 29010
        • Research Site
      • Pontevedra, Spagna, 36312
        • Research Site
      • Pozuelo de Alarcón, Spagna, 28223
        • Research Site
      • Santander, Spagna, 39008
        • Research Site
      • Toledo, Spagna, 45007
        • Research Site
      • Zaragoza, Spagna, 50009
        • Research Site
  • Stati Uniti
    • California
      • Duarte, California, Stati Uniti, 91010
        • Research Site
      • Palo Alto, California, Stati Uniti, 94304
        • Research Site
    • Georgia
      • Marietta, Georgia, Stati Uniti, 30060
        • Research Site
    • Illinois
      • Evanston, Illinois, Stati Uniti, 60201
        • Research Site
    • Kentucky
      • Edgewood, Kentucky, Stati Uniti, 41017
        • Research Site
      • Louisville, Kentucky, Stati Uniti, 40202
        • Research Site
    • Nevada
      • Reno, Nevada, Stati Uniti, 89502
        • Research Site
    • South Dakota
      • Sioux Falls, South Dakota, Stati Uniti, 57105
        • Research Site
    • Tennessee
      • Nashville, Tennessee, Stati Uniti, 37204
        • Research Site
    • Texas
      • Fort Worth, Texas, Stati Uniti, 76104
        • Research Site
      • Kingwood, Texas, Stati Uniti, 77339
        • Research Site
    • Virginia
      • Midlothian, Virginia, Stati Uniti, 23114
        • Research Site
  • Svizzera
      • Basel, Svizzera, 4031
        • Research Site
      • Liestal, Svizzera, CH-4410
        • Research Site
      • Rennaz, Svizzera, 1847
        • Research Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Altri nomi:
  • AZD9833
Droga: Ribociclib
Patients will receive the standard dose of ribociclib once daily as oral tablets
Altri nomi:
  • KISQALI®

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Efficacy of camizestrant and ribociclib by time to next treatment (TTNT)
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Efficacy of camizestrant and ribociclib by time to discontinuation (TTD)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

AstraZeneca

Collaboratori

ICON plc

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

26 maggio 2026

Completamento primario (Stimato)

20 aprile 2028

Completamento dello studio (Stimato)

10 aprile 2034

Date di iscrizione allo studio

Primo inviato

12 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

9 giugno 2026

Primo Inserito (Effettivo)

15 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 giugno 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • D8532C00008

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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

Periodo di condivisione 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.

Criteri di accesso alla condivisione 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 di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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