Breast Cancer Clinical Trial
A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
Summary
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.
Full Description
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months. The eligible patients must have intermediate or high risk of recurrence, as defined by specified clinical and biologic criteria. Prior use of CDK4/6 inhibitors is permitted. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs).
Patients will be followed for 10 years from randomization of the last patient.
Eligibility Criteria
Inclusion Criteria:
Women and Men, ≥18 years at the time of screening (or per national guidelines)
Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with high or intermediate risk of recurrence, based on clinical-pathological risk features, as defined in the protocol.
Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy
Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET
Prior adjuvant therapy with CDK4/6 inhibitors for 2 years is allowed
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
Adequate organ and marrow function
Exclusion criteria:
Inoperable locally advanced or metastatic breast cancer
Pathological complete response following treatment with neoadjuvant therapy
History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix or considered at very low risk of recurrence per investigator judgement) unless in complete remission with no therapy for a minimum of 5 years from the date of randomisation
Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion precludes participation in the study or compliance
Known LVEF <50% with heart failure NYHA Grade ≥2.
Mean resting QTcF interval >470 ms at screening
Concurrent exogenous reproductive hormone therapy or non-topical hormonal therapy for non-cancer-related conditions
Any concurrent anti-cancer treatment not specified in the protocol with the exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors (eg, denosumab)
Previous treatment with camizestrant, investigational SERDs/investigational ER targeting agents, or fulvestrant
Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding
Patients with known hypersensitivity to active or inactive excipients of camizestrant or drugs with a similar chemical structure or class to camizestrant. In pre-/peri-menopausal female and male patients, known hypersensitivity or intolerance to LHRH agonists, that would preclude the patient from receiving any LHRH agonist
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There are 112 Locations for this study
Farmington New Mexico, 87401, United States
Nashville Tennessee, 37203, United States
Ogden Utah, 84405, United States
Buenos Aires , C1426, Argentina
Buenos Aires , C1430, Argentina
Caba , C1119, Argentina
Capital Federal , C1417, Argentina
Ciudad Autonoma de Buenos Aires , C1118, Argentina
Ciudad Autónoma Buenos Aires , 1125, Argentina
Ciudad de Buenos Aires , 1280, Argentina
Cordoba , 5000, Argentina
Cordoba , 5001, Argentina
La Plata , 1900, Argentina
Mar del Plata , 7600, Argentina
Salta , A4400, Argentina
San Juan , 5400, Argentina
San Miguel de Tucuman , T4000, Argentina
San Miguel de Tucumán , 4000, Argentina
Viedma , R8500, Argentina
Birtinya , 4575, Australia
Brighton , 3186, Australia
Concord , 2139, Australia
Nedlands , 6009, Australia
Randwick , 2031, Australia
Tweed Heads , 2485, Australia
Waratah , 2298, Australia
Wendouree , 3355, Australia
Graz , 8036, Austria
Innsbruck , 6020, Austria
Linz , 4010, Austria
Ried , 4910, Austria
St. Veit an der Glan , 9300, Austria
Vienna , 1090, Austria
Voecklabruck , 4840, Austria
Wein , 1130, Austria
Wels , 4600, Austria
Wien , 1090, Austria
Brasschaat , 2930, Belgium
Brussel , 1090, Belgium
Edegem , 2650, Belgium
Gent , 9000, Belgium
Leuven , 8500, Belgium
Liege , 4000, Belgium
Mons , 7000, Belgium
Ottignies , 1340, Belgium
Wilrijk , 2610, Belgium
Yvoir , 5530, Belgium
Barretos , 14784, Brazil
Belo Horizonte , 30130, Brazil
Belo Horizonte , 30150, Brazil
Brasília , 70390, Brazil
Chapeco , 89812, Brazil
Curitiba , 80810, Brazil
Curitiba , 81520, Brazil
Fortaleza , 60170, Brazil
Fortaleza , 60430, Brazil
Lajeado , 95900, Brazil
Londrina , 86015, Brazil
Natal , 59075, Brazil
Niterói , 24020, Brazil
Piracicaba , 13419, Brazil
Porto Alegre , 90035, Brazil
Porto Alegre , 90050, Brazil
Porto Alegre , 90610, Brazil
Porto Alegre , 90880, Brazil
Ribeirão Preto , 14051, Brazil
Rio de Janeiro , 20560, Brazil
Rio de Janeiro , 22250, Brazil
Rio De Janeiro , 22290, Brazil
Salvador , 40110, Brazil
Salvador , 41253, Brazil
Sao Paulo , 01246, Brazil
Sao Paulo , 01317, Brazil
Sao Paulo , 01508, Brazil
Sao Paulo , 15090, Brazil
São Paulo , 01236, Brazil
São Paulo , 01323, Brazil
São Paulo , 03102, Brazil
São Paulo , 08270, Brazil
Taubaté , 12030, Brazil
Tres Lagoas , 79601, Brazil
Vitória , 29055, Brazil
Dobrich , 9300, Bulgaria
Plovdiv , 4004, Bulgaria
Sofia , 1330, Bulgaria
Sofia , 1407, Bulgaria
Sofia , 1431, Bulgaria
Sofia , 1606, Bulgaria
Barranquilla , 08002, Colombia
Barranquilla , 80020, Colombia
Bogota , 11022, Colombia
Bogota , 11151, Colombia
Cali , 76004, Colombia
Floridablanca , 68100, Colombia
Medellin , 50030, Colombia
Monteria , 23001, Colombia
Pereira , , Colombia
Valledupar , 20000, Colombia
Alc. Cuauhtémoc , 06100, Mexico
Bloemfontein , 9301, South Africa
George , 6529, South Africa
Johannesburg , 2196, South Africa
Pietermaritzburg , 3201, South Africa
Ankara , 06100, Turkey
Ankara , 06200, Turkey
Ankara , 06520, Turkey
Ankara , 06620, Turkey
Ankara , 6800, Turkey
Aydin , 9010, Turkey
Bursa , 16059, Turkey
Dinar , 03400, Turkey
Istambul , 34218, Turkey
Istanbul , 34010, Turkey
Istanbul , 34899, Turkey
İzmir , 35120, Turkey
Izmir , 35150, Turkey
Izmir , 35575, Turkey
Samsun , 55200, Turkey
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