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An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)
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 within the study will be 7 years.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-10-05
Primary completion: 2030-03-04
Study completion finish: 2037-05-06
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT05952557
Intervention or treatment
DRUG: Camizestrant
DRUG: Tamoxifen
DRUG: Anastrozole
DRUG: Letrozole
DRUG: Exemestane
DRUG: Abemaciclib
Conditions
- • Breast Cancer, Early Breast Cancer
Find a site
Closest Location:
Research Site
Research sites nearby
Select from list below to view details:
Research Site
Clayton, Not Specified, Australia
Research Site
Liverpool, Not Specified, Australia
Research Site
Randwick, Not Specified, Australia
Research Site
South Brisbane, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
ACTIVE_COMPARATOR: Arm A: standard endocrine therapy of investigator´s choice ± abemaciclib
| DRUG: Tamoxifen
|
EXPERIMENTAL: Arm B: camizestrant ± abemaciclib
| DRUG: Camizestrant
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Invasive breast cancer-free survival (IBCFS) | IBCFS is defined as time from randomisation until date of first occurrence of: * Invasive ipsilateral breast tumour recurrence * Locoregional invasive breast cancer recurrence * Distant recurrence * Contralateral invasive breast cancer * Death attributable to any cause. | Up to 14 years |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Invasive disease-free survival (IDFS) | IDFS is defined as time from randomisation until date of first occurrence of one of the following events: * Invasive ipsilateral breast tumor recurrence * Locoregional invasive breast cancer recurrence * Distant recurrence * Contralateral invasive breast cancer * Second primary non-breast invasive cancer * Death attributable to any cause. | Up to 14 years |
Distant relapse-free survival (DRFS) | DRFS is defined as time from randomisation until date of first distant recurrence or death from any cause, whichever occurs first. | Up to 14 years |
Overall survival (OS) | OS is defined as time from randomisation until death from any cause. | Up to 14 years |
Incidence and Severity of Adverse Events, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0) | Not Specified | Until 28 days after the final dose of study treatment (up to 7 years) |
Proportion of time on study treatment with high side-effect burden as measured by the PGI-TT. | Not Specified | Until 28 days after the final dose of study treatment (up to 7 years) |
Change from baseline and time to deterioration of health-related quality of life as measured by the 2 global QoL items from the EORTC IL-311 | Not Specified | Until 28 days after the final dose of study treatment (up to 7 years) |
Pharmacokinetics (PK) | Plasma concentrations of camizestrant pre-dose (trough concentration) | Until 6 months from treatment start |
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