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.

View Full Description

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.

View Eligibility Criteria

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 (+/- CDK4/6 inhibitor)
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 >480 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

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

4300

Study ID:

NCT05774951

Recruitment Status:

Recruiting

Sponsor:

AstraZeneca

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There are 647 Locations for this study

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Research Site
Farmington New Mexico, 87401, United States
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Nashville Tennessee, 37203, United States
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Ogden Utah, 84405, United States
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Buenos Aires , C1426, Argentina
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Buenos Aires , C1430, Argentina
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Caba , C1119, Argentina
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Capital Federal , C1417, Argentina
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Ciudad Autonoma de Buenos Aires , C1118, Argentina
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Ciudad Autónoma Buenos Aires , 1125, Argentina
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Ciudad de Buenos Aires , 1280, Argentina
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Cordoba , 5000, Argentina
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Cordoba , 5001, Argentina
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La Plata , 1900, Argentina
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Mar del Plata , 7600, Argentina
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Salta , A4400, Argentina
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San Juan , 5400, Argentina
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San Miguel de Tucuman , T4000, Argentina
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San Miguel de Tucumán , 4000, Argentina
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Viedma , R8500, Argentina
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Birtinya , 4575, Australia
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Brighton , 3186, Australia
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Concord , 2139, Australia
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Nedlands , 6009, Australia
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Randwick , 2031, Australia
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Tweed Heads , 2485, Australia
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Waratah , 2298, Australia
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Wendouree , 3355, Australia
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Graz , 8036, Austria
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Innsbruck , 6020, Austria
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Linz , 4010, Austria
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Ried , 4910, Austria
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St. Veit an der Glan , 9300, Austria
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Vienna , 1090, Austria
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Voecklabruck , 4840, Austria
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Wein , 1130, Austria
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Wels , 4600, Austria
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Wien , 1090, Austria
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Brasschaat , 2930, Belgium
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Brussel , 1090, Belgium
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Edegem , 2650, Belgium
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Gent , 9000, Belgium
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Leuven , 8500, Belgium
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Liege , 4000, Belgium
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Mons , 7000, Belgium
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Ottignies , 1340, Belgium
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Wilrijk , 2610, Belgium
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Yvoir , 5530, Belgium
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Barretos , 14784, Brazil
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Belo Horizonte , 30130, Brazil
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Belo Horizonte , 30150, Brazil
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Brasília , 70390, Brazil
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Chapeco , 89812, Brazil
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Curitiba , 80810, Brazil
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Curitiba , 81520, Brazil
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Fortaleza , 60170, Brazil
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Fortaleza , 60430, Brazil
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Lajeado , 95900, Brazil
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Londrina , 86015, Brazil
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Natal , 59075, Brazil
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Niterói , 24020, Brazil
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Piracicaba , 13419, Brazil
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Porto Alegre , 90035, Brazil
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Porto Alegre , 90050, Brazil
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Porto Alegre , 90610, Brazil
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Porto Alegre , 90880, Brazil
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Ribeirão Preto , 14051, Brazil
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Rio de Janeiro , 20560, Brazil
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Rio de Janeiro , 22250, Brazil
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Rio De Janeiro , 22290, Brazil
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Salvador , 40110, Brazil
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Salvador , 41253, Brazil
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Sao Paulo , 01246, Brazil
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Sao Paulo , 01317, Brazil
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Sao Paulo , 01508, Brazil
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Sao Paulo , 15090, Brazil
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São Paulo , 01236, Brazil
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São Paulo , 01323, Brazil
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São Paulo , 03102, Brazil
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São Paulo , 08270, Brazil
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Taubaté , 12030, Brazil
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Tres Lagoas , 79601, Brazil
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Vitória , 29055, Brazil
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Dobrich , 9300, Bulgaria
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Plovdiv , 4004, Bulgaria
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Sofia , 1330, Bulgaria
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Sofia , 1407, Bulgaria
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Sofia , 1431, Bulgaria
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Sofia , 1606, Bulgaria
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Barranquilla , 08002, Colombia
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Barranquilla , 80020, Colombia
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Bogota , 11022, Colombia
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Bogota , 11151, Colombia
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Cali , 76004, Colombia
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Floridablanca , 68100, Colombia
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Medellin , 50030, Colombia
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Monteria , 23001, Colombia
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Pereira , , Colombia
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Valledupar , 20000, Colombia
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Alc. Cuauhtémoc , 06100, Mexico
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Bloemfontein , 9301, South Africa
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George , 6529, South Africa
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Johannesburg , 2196, South Africa
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Pietermaritzburg , 3201, South Africa
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Ankara , 06100, Turkey
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Ankara , 06200, Turkey
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Ankara , 06520, Turkey
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Ankara , 06620, Turkey
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Ankara , 6800, Turkey
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Aydin , 9010, Turkey
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Bursa , 16059, Turkey
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Dinar , 03400, Turkey
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Istambul , 34218, Turkey
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Istanbul , 34010, Turkey
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Istanbul , 34899, Turkey
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Ä°zmir , 35120, Turkey
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Izmir , 35150, Turkey
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Izmir , 35575, Turkey
Research Site
Samsun , 55200, Turkey

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

4300

Study ID:

NCT05774951

Recruitment Status:

Recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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