Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05774951
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2023-02-16
Brief Title:
A Study of Camizestrant in ERHER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
CAMBRIA-1 A Phase III Open-Label Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant AZD9833 a Next Generation Oral Selective Estrogen Receptor Degrader Versus Standard Endocrine Therapy Aromatase Inhibitor or Tamoxifen in Patients With ERHER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAMBRIA-1
Brief Summary:
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ERHER2 - 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
Detailed Description:
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ERHER2 - 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 CDK46 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
Patients will be followed for 10 years from randomization of the last patient
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-501024-20-00 | OTHER | EMA - CTIS | None |