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SERENA-2: AZD9833 vs Fulvestrant in Advanced ER-Positive HER2-Negative Breast Cancer
NCT04214288Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Apr 2020
- Primary completion
- Aug 2022
- Countries
- 16
- Sponsor
- AstraZeneca
- Modality
- Small Molecules
- Drugs
- camizestrant
- Conditions
- breast cancer
01
Overview
Phase 2, randomised, open-label trial of camizestrant in breast cancer (4 arms), sponsored by AstraZeneca. Primary endpoint: Progression-free Survival up to 29 months. Started Apr 2020; status: active, not recruiting.
02
Design
4 arms- Study design
- RandomizedOpen-label
AZD9833 Dose A
Oral AZD9833 Dose A
AZD9833 Dose B
Oral AZD9833 Dose B
AZD9833 Dose C
Oral AZD9833 Dose C (enrollment stopped Dec 2020)
Fulvestrant 500 mg
Intramuscular Fulvestrant 500 mg
03
Who it enrols
Post-menopausal women >=18 years with ER+/HER2- advanced breast cancer who have progressed on at least one prior endocrine therapy, with ECOG 0-1 and measurable disease.
04
Endpoints
Primary
Progression-free Survival
Secondary
Objective Response Rate
Duration of Response
Percentage Change in Tumour Size
Overall Survival
Clinical Benefit Rate
Plasma Concentrations of AZD9833
Percent Change From Baseline in ER and PgR Expression and Ki67 Labelling Index
Health Related Quality of Life
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