Last updated 17 days ago
An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)
5500 patients around the world
Available in Colombia, United States, Mexico, Chile, Peru, Argentina, Brazil
This is a Phase III open-label study to assess if camizestrant improves outcomes compared
to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer
with intermediate-high or high risk for disease recurrence who completed definitive
locoregional therapy (with or without chemotherapy). The planned duration of treatment in
either arm of the study is 7 years. Eligible patients must have intermediate-high or high
risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use
of abemaciclib is permitted in both arms. 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
7Research sites
5500Patients 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 absence of any evidence of metastatic disease 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.Patients must be randomised within 12 months of definitive breast surgery.Patients may have received up to 12 weeks of endocrine therapy prior to randomisation.Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1Adequate organ and bone 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 a 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 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.
Sites
Hospital Británico de Buenos Aires - CABA
Recruiting
Centro de Investigaciones Clínicas - Clínica Viedma - Río Negro
Recruiting
CIPREC Centro de Investigación y Prevención Cardiovascular - CABA
Recruiting
Hospital Alemán
Recruiting
Fundación CENIT para la Investigación en Neurociencias
Recruiting
Centro Médico San Roque S.R.L. - Tucumán
Recruiting
Clínica El Castaño
Recruiting
StudyCAMBRIA-2
SponsorAstraZeneca
Conditions
Breast Cancer
Requirements
To 130 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05952557
