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CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients With ER+/HER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504031-41-00
Acronym
D8535C00001
Enrollment
2049
Registered
2024-01-10
Start date
2024-03-25
Completion date
Unknown
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ER+/HER2- Early Breast Cancer

Brief summary

Primary efficacy IBCFS (invasive breast cancer free-survival) as defined by STEEP 2.0 criteria

Detailed description

Secondary efficacy IDFS(invasive disease-free survival) as defined by STEEP 2.0 criteria DRFS(distant relapse-free survival) as defined by STEEP 2.0 criteria OS(overall survival), Secondary safety Safety endpoints including: • TEAEs(treatment-emergent adverse event), SAEs(serious adverse event) • Clinical laboratory tests and vital signs, Secondary COAs(clinical outcome assessment): Proportion of time on study treatment with high side-effect burden as measured by the PGI-TT, Secondary COAs (clinical outcome assessment) Change from baseline and TTD(time to deterioration ) of health-related QoL(quality of life) as measured by the 2 global QoL (quality of life) items from the EORTC IL-311 (European Organisation for Research and Treatment of Cancer), Secondary PK(pharmacokinetic(s) Plasma concentrations of camizestrant pre-dose (Ctrough)( trough concentration)

Interventions

DRUGEXEMESTANE
DRUGTRIPTORELIN
DRUGLETROZOLE
DRUGLEUPRORELIN ACETATE
DRUGGOSERELIN
DRUGABEMACICLIB

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Primary efficacy IBCFS (invasive breast cancer free-survival) as defined by STEEP 2.0 criteria

Secondary

MeasureTime frame
Secondary efficacy IDFS(invasive disease-free survival) as defined by STEEP 2.0 criteria DRFS(distant relapse-free survival) as defined by STEEP 2.0 criteria OS(overall survival), Secondary safety Safety endpoints including: • TEAEs(treatment-emergent adverse event), SAEs(serious adverse event) • Clinical laboratory tests and vital signs, Secondary COAs(clinical outcome assessment): Proportion of time on study treatment with high side-effect burden as measured by the PGI-TT, Secondary COAs (clinical outcome assessment) Change from baseline and TTD(time to deterioration ) of health-related QoL(quality of life) as measured by the 2 global QoL (quality of life) items from the EORTC IL-311 (European Organisation for Research and Treatment of Cancer), Secondary PK(pharmacokinetic(s) Plasma concentrations of camizestrant pre-dose (Ctrough)( trough concentration)

Countries

Austria, Belgium, Bulgaria, Croatia, Czechia, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Poland, Portugal, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026