A Study of ARV-471 (PF-07850327) Plus Palbociclib Versus Letrozole Plus Palbociclib in Participants With Estrogen Receptor Positive, Human Epidermal Growth Factor Negative Advanced Breast Cancer
Lakeland Regional Cancer Center 33805 Lakeland United StatesRekrutierend» Google-MapsMid Florida Hematology and Oncology Center 32763 Orange City United StatesRekrutierend» Google-MapsUniversity of Michigan 48109 Ann Arbor United StatesRekrutierend» Google-Maps
Mercy Clinic Oncology and Hematology 63011 Ballwin United StatesNoch nicht rekrutierend» Google-MapsMercy Research - David C. Pratt Cancer Center 63141 Saint Louis United StatesNoch nicht rekrutierend» Google-MapsSarah Cannon Research Institute 37203-1503 Nashville United StatesNoch nicht rekrutierend» Google-MapsSCRI Oncology Partners 37203 Nashville United StatesNoch nicht rekrutierend» Google-MapsVirginia Oncology Associates 23502 Norfolk United StatesNoch nicht rekrutierend» Google-MapsCancer Research SA 5000 Adelaide AustraliaRekrutierend» Google-MapsCabrini Hospital -Brighton 3186 Brighton AustraliaNoch nicht rekrutierend» Google-MapsBarwon Health 3220 Geelong AustraliaRekrutierend» Google-MapsCabrini Hospital - Malvern 3144 Malvern AustraliaNoch nicht rekrutierend» Google-MapsHospital Santa Rita de Cassia 29043-260 Vitoria BrazilNoch nicht rekrutierend» Google-MapsCentro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa 90110-270 Porto Alegre BrazilRekrutierend» Google-MapsCentro de Pesquisa Clínica - Área Administrativa 90850-170 Porto Alegre BrazilRekrutierend» Google-MapsHospital Mae de Deus 90880-480 Porto Alegre BrazilRekrutierend» Google-MapsA. C. Camargo Cancer Center 01509-010 SP BrazilNoch nicht rekrutierend» Google-MapsCancer Hospital Chinese Academy of Medical Science 100021 Beijing ChinaAktiv, nicht rekrutierend» Google-MapsSun Yat-sen University Cancer Center 510060 Guangzhou ChinaRekrutierend» Google-MapsHubei Cancer Hospital 430079 Wuhan ChinaRekrutierend» Google-MapsThe First Affiliated Hospital of Xi'an Jiaotong University 710061 Xi'an ChinaRekrutierend» Google-MapsSir Run Run Shaw Hospital of Zhejiang University School of Medicine 310016 Hangzhou ChinaNoch nicht rekrutierend» Google-MapsDebreceni Egyetem Klinikai Kozpont 04032 Debrecen HungaryRekrutierend» Google-MapsIstituto Nazionale Tumori IRCCS Fondazione Pascale 80131 Napoli ItalyRekrutierend» Google-MapsIRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" 47014 Meldola ItalyRekrutierend» Google-MapsFondazione IRCCS San Gerardo dei Tintori 20900 Monza ItalyRekrutierend» Google-MapsAichi Cancer Center Hospital 464-8681 Nagoya JapanRekrutierend» Google-MapsNational Cancer Center Hospital East 277-8577 Kashiwa JapanRekrutierend» Google-MapsNational Cancer Center Hospital 104-0045 Chuo-ku JapanRekrutierend» Google-MapsNemocnica na okraji mesta n o 95801 Partizanske SlovakiaRekrutierend» Google-MapsFakultna nemocnica s poliklinikou J.A. Reimana Presov 080 01 Presov SlovakiaRekrutierend» Google-MapsInstitut Català d'Oncologia (ICO) - Badalona 08916 Badalona SpainRekrutierend» Google-MapsHospital Universitari Dexeus 08028 Barcelona SpainRekrutierend» Google-MapsComplejo Hospitalario de Jaén 23007 Jaen SpainRekrutierend» Google-MapsHospital Universitario Virgen de la Victoria 29010 Malaga SpainRekrutierend» Google-MapsHospital Unviersitario Virgen Nieves 18012 Granada SpainRekrutierend» Google-MapsHospital Clinico San Carlos 28040 Madrid SpainRekrutierend» Google-MapsTumor Zentrum Aarau 5000 Aarau SwitzerlandRekrutierend» Google-MapsCHUV (centre hospitalier universitaire vaudois) 1011 Lausanne SwitzerlandNoch nicht rekrutierend» Google-Maps
1. Study Lead-in (SLI): Incidence of Grade 4 neutropenia (Time Frame - From randomization date up to Cycle 4 (each cycle is 28 days).): It is defined as the number of participants with Grade 4 neutropenia AE (graded by NCI CTCAE v.5.0) with onset within the first 4 cycles divided by the number of participants.
2. SLI: Incidence of dose reduction (Time Frame - From randomization date up to Cycle 4 (each cycle is 28 days).): It is defined as the number of participants reducing the dose of palbociclib and/or ARV-471 due to any cause occurring within the first 4 cycles divided by the number of participants.
3. SLI: Incidence of drug discontinuation. (Time Frame - From randomization date up to Cycle 4 (each cycle is 28 days).): It is defined as the number of participants discontinuing palbociclib and/or ARV-471 due to any cause occurring within the first 4 cycles divided by the number of participants.
4. Phase 3: Progression-Free Survival (Time Frame - From randomization date, every 12 weeks, to date of first documentation of progression or death, up to approximately 4 years.): Progression-free survival is defined as the time interval from the date of randomization to the date of first documented tumor progression determined by Blinded Independent Central Review (BICR) as per Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) or death due to any cause, whichever come first.
Secondary outcome:
1. SLI and Phase 3. Objective Response Rate (Time Frame - From randomization date, every 12 weeks, to the date of progression or death (up to approximately 4 years).): Objective response rate is defined as the proportion of participants who have a confirmed CR or PR, as best overall response determined by Investigators (SLI) or by BICR (Phase 3) as per RECIST version 1.1, from the date of randomization to the date of disease progression or death due to any cause, whichever occurs first.
2. SLI and Phase 3: Duration of Response (Time Frame - From the date of the first objective response, every 12 weeks, to the date of disease progression or death (up to approximately 4 years).): Duration of response is defined as the time from first documented evidence of CR or PR until progressive disease (PD) determined by Investigators (SLI) or by BICR (Phase 3) as per RECIST version 1.1 or death due to any cause, whichever occurs first.
3. SLI and Phase 3: Clinical Benefit Rate (Time Frame - Every 12 weeks From randomization date, every 12 week, to the date of progression or death (up to approximately 4 years).): Clinical benefit rate is defined as the proportion of participants who have a confirmed CR, PR at any time or SD or non CR/non PD for at least 24 weeks determined by Investigators (SLI) or by BICR (Phase 3) as per RECIST version 1.1, from the date of randomization until disease progression or death due to any cause, whichever occurs first.
4. Phase 3: Overall Survival (Time Frame - From randomization date, every 3 months, to date of death (up to approximately 6 years)): Overall survival is defined as the time interval from the date of randomization to the date of documented death, due to any cause.
5. SLI and Phase 3: Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Time Frame - From baseline to date to end of treatment (up to approximately 4 years)): It is defined as the number of participants with TEAEs and SAEs divided by the number of participants. AEs and SAEs will be graded according to NCI CTCAE V5.0.
6. SLI and Phase 3: Incidence of laboratory abnormalities (Time Frame - From baseline to end of treatment (up to approximately 4 years)): It is defined as the number of participants with laboratory abnormalities divided by the number of participants. Laboratory abnormalities will be graded according to NCI CTCAE V5.0.
7. SLI and Phase 3: Incidence of Electrocardiogram (ECG) Abnormalities (Time Frame - From baseline up to the end of treatment (up to approximately 4 years)): It is defined as the number of participants with ECG abnormalities divided by the number of participants. ECG abnormalities will be graded according to NCI CTCAE V5.0.
8. SLI and Phase 3: Plasma concentrations of ARV-471 and palbociclib (Time Frame - From randomization date up to Cycle 5 (each cycle is 28 days)): Plasma concentrations of ARV-471 and palbociclib
9. Phase 3: Health state utility and health status will be assessed using the European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L) (Time Frame - From baseline, each cycle up to cycle 3, then every odd cycle to end of treatment (up to approximately 4 years). Each cycle is 28 days): Change from baseline between treatment comparison in Quality of Life using the EQ-5D 5L questionnaire.
10. Phase 3: Disease-related Quality of Life will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30) (Time Frame - From baseline, each cycle up to Cycle 3, then every odd cycle to end of treatment (up to approximately 4 years). Each cycle is 28 days.): Change from baseline between treatment comparison in Quality of Life using the EORTC QLQ-C30 questionnaire.
11. Phase 3: Disease- and treatment-related Quality of Life will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) breast cancer module (QLQ-BR23) questionnaire. (Time Frame - From baseline, each cycle up to Cycle 3, then every odd cycle to end of treatment (up to approximately 4 years). Each cycle is 28 days.): Change from baseline between treatment comparison in Quality of Life Using the EORTC QLQ-BR23 (Breast) questionnaire.
12. Phase 3: Changes from baseline in plasma ctDNA (Circulating Deoxyribonucleic Acid) (Time Frame - From baseline to end of treatment (up to approximately 4 years)): Quantitative changes from baseline
Experimental: Arm A (Investigational Arm) Participants will receive:
ARV-471, orally, once daily, continuously, in a 28-day cycle, plus
Palbociclib, orally, once daily for 21 consecutive days followed by 7 days off treatment in a 28 day cycle
Active Comparator: Arm B (Comparator Arm): Participants will receive:
Letrozole, orally, once daily, continuously, in a 28-day cycle, plus
Palbociclib, orally, once daily for 21 consecutive days followed by 7 days off treatment, in a 28-day cycle.
ARV-471 (PF-07850327) (Vepdegestrant): Pharmaceutical form: Tablets. Route of Administration: Oral
Palbociclib (IBRANCE®): Pharmaceutical form: Capsules. Route of Administration: Oral.
Letrozole (FEMARA®): Pharmaceutical form: Capsules. Route of Administration: Orally
Palbociclib (IBRANCE®): Pharmaceutical form: Capsules. Route of Administration: Oral.
Quelle: ClinicalTrials.gov
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"A Study of ARV-471 (PF-07850327) Plus Palbociclib Versus Letrozole Plus Palbociclib in Participants With Estrogen Receptor Positive, Human Epidermal Growth Factor Negative Advanced Breast Cancer"
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