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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- Phase 3
Contacts et emplacements
Coordonnées de l'étude
- Nom: AstraZeneca Clinical Study Information Center
- Numéro de téléphone: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
Lieux d'étude
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Berlin, Allemagne, 13125
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Düsseldorf, Allemagne, 40235
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Erlangen, Allemagne, 91054
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Freiburg im Breisgau, Allemagne, 79110
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Mönchengladbach, Allemagne, 41061
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München, Allemagne, 81675
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Paderborn, Allemagne, 33098
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Trier, Allemagne, 54290
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Velbert, Allemagne, 42551
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Cheonan-si, Corée du Sud, 31151
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Daegu, Corée du Sud, 42415
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Goyang-si, Corée du Sud, 10408
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Hwasun-eup, Corée du Sud, 58128
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Incheon, Corée du Sud, 405-760
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Seongbuk-Gu, Corée du Sud, 02841
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Seongnam-si, Corée du Sud, 13620
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Seongnam-si, Corée du Sud, 13520
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Seoul, Corée du Sud, 3722
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Seoul, Corée du Sud, 03080
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Seoul, Corée du Sud, 06591
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Seoul, Corée du Sud, 06273
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Seoul, Corée du Sud, 06351
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Seoul, Corée du Sud, 07985
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Songpa-gu, Corée du Sud, 05505
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Suwon, Corée du Sud, 16499
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Abu Dhabi, Emirats Arabes Unis, 11241
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Al Ain City, Emirats Arabes Unis, 00000
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Dubai, Emirats Arabes Unis, 505004
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Mohammed Bin Zayed City, Emirats Arabes Unis, 92510
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Badajoz, Espagne, 06080
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Badalona, Espagne, 08916
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Barcelona, Espagne, 08041
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Burgos, Espagne, 9006
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Donostia / San Sebastian, Espagne, 20014
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Huelva, Espagne, 21005
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Jaén, Espagne, 23007
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Las Palmas de Gran Canaria, Espagne, 35016
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Majadahonda, Espagne, 28222
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Murcia, Espagne, 30008
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Málaga, Espagne, 29010
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Oviedo, Espagne, 33011
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Palma de Mallorca, Espagne, 07198
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Pontevedra, Espagne, 36312
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Pozuelo de Alarcón, Espagne, 28223
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Santander, Espagne, 39008
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Toledo, Espagne, 45007
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Zaragoza, Espagne, 50009
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Angers, France, 49933
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Bayonne, France, 64109
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Bobigny, France, 93000
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Caen, France, 14000
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Chambray-lès-Tours, France, 37170
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Grenoble, France, 38043
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Montpellier, France, 34070
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Nancy, France, 54100
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Nîmes, France, 30029
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Paris, France, 75014
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Pierre-Bénite, France, 69310
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Valenciennes, France, 59300
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Vandœuvre-lès-Nancy, France, 54519
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Villejuif, France, 94805
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Aviano, Italie, 33081
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Bergamo, Italie, 24127
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Genova, Italie, 16132
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Milan, Italie, 20127
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Naples, Italie, 80131
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Gdansk, Pologne, 80-952
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Konin, Pologne, 62-500
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Krakow, Pologne, 30-688
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Lodz, Pologne, 90-302
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Lublin, Pologne, 20-090
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Poznan, Pologne, 61-485
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Przemyśl, Pologne, 37-700
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Wroclaw, Pologne, 53-413
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Basel, Suisse, 4031
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Liestal, Suisse, CH-4410
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Rennaz, Suisse, 1847
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California
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Duarte, California, États-Unis, 91010
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Palo Alto, California, États-Unis, 94304
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Georgia
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Marietta, Georgia, États-Unis, 30060
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Illinois
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Evanston, Illinois, États-Unis, 60201
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Kentucky
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Edgewood, Kentucky, États-Unis, 41017
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Louisville, Kentucky, États-Unis, 40202
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Nevada
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Reno, Nevada, États-Unis, 89502
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South Dakota
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Sioux Falls, South Dakota, États-Unis, 57105
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Tennessee
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Nashville, Tennessee, États-Unis, 37204
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Texas
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Fort Worth, Texas, États-Unis, 76104
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Kingwood, Texas, États-Unis, 77339
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Virginia
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Midlothian, Virginia, États-Unis, 23114
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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
Autres noms:
Patients will receive the standard dose of ribociclib once daily as oral tablets
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Efficacy of camizestrant and ribociclib by time to next treatment (TTNT)
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Efficacy of camizestrant and ribociclib by time to discontinuation (TTD)
Délai: 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)
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- D8532C00008
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
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