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

9. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

150

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Camizestrant and Ribociclib
Patients will receive the standard dose of camizestrant and ribociclib once daily as oral tablets
Medicin: Camizestrant
Patients will receive the standard dose of camizestrant once daily as oral tablets
Andre navne:
  • AZD9833
Medicin: Ribociclib
Patients will receive the standard dose of ribociclib once daily as oral tablets
Andre navne:
  • KISQALI®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Efficacy of camizestrant and ribociclib by time to next treatment (TTNT)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Efficacy of camizestrant and ribociclib by time to discontinuation (TTD)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AstraZeneca

Samarbejdspartnere

ICON plc

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

26. maj 2026

Primær færdiggørelse (Anslået)

20. april 2028

Studieafslutning (Anslået)

10. april 2034

Datoer for studieregistrering

Først indsendt

12. maj 2026

Først indsendt, der opfyldte QC-kriterier

9. juni 2026

Først opslået (Faktiske)

15. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D8532C00008

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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.

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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