Last updated 16 days ago
A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
4300 patients around the world
Available in Colombia, United States, Mexico, Argentina, Brazil
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.
AstraZeneca
14Research sites
4300Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
To 130 Years
All Gender
Medical requirements
- 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 chemotherapyCompleted 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 ≤ 1Adequate organ and marrow function
- Inoperable locally advanced or metastatic breast cancerPathological complete response following treatment with neoadjuvant therapyHistory 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 randomisationAny evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion precludes participation in the study or complianceKnown LVEF <50% with heart failure NYHA Grade ≥2.Mean resting QTcF interval >480 ms at screeningConcurrent exogenous reproductive hormone therapy or non-topical hormonal therapy for non-cancer-related conditionsAny 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 fulvestrantCurrently pregnant (confirmed with positive serum pregnancy test) or breastfeedingPatients 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
Sites
Hospital Británico de Buenos Aires - CABA
Recruiting
Centro de Investigaciones Clínicas - Clínica Viedma - Río Negro
Recruiting
Instituto de Investigaciones Clínicas Mar del Plata
Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
Recruiting
CIPREC Centro de Investigación y Prevención Cardiovascular - CABA
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Centro Médico Caipo (centro para la atención integral de pacientes oncológicos)
Recruiting
Hospital Alemán
Recruiting
Centro Médico San Roque S.R.L. - Tucumán
Recruiting
Instituto de Oncología Ángel H. Roffo - CABA, Buenos Aires
Recruiting
StudyCAMBRIA-1
SponsorAstraZeneca
Conditions
Breast Cancer
Requirements
To 130 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05774951
