CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 240 enrolled / 240 target
Drug / intervention
AZD9833 +1 moredrug
Likely dose
500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04214288
NCT04214288Phase 2ActiveUpdate Overdue (3.2/mo)Completion was 46mo ago
CompareCT.gov

SERENA-2: A Randomised, Open-Label, Parallel-Group, Multicentre Phase 2 Study Comparing the Efficacy and Safety of Oral AZD9833 Versus Fulvestrant in Women With Advanced ER-Positive HER2-Negative Breast Cancer

AstraZeneca·interventional·Posted Jan 2, 2020·Updated Jun 15, 2026

In Brief

A Phase 2 clinical trial evaluating AZD9833 and Fulvestrant for Advanced ER-Positive HER2-Negative Breast Cancer. Active but no longer recruiting, targeting 240 participants across 85 sites in 16 countries.

Signals

Enrollment appears stalled

Detailed Summary

This study is randomized, open-label, parallel-group, multicentre Phase 2 study aimed to compare the efficacy and safety of oral AZD9833 versus intramuscular (IM) fulvestrant in women with advanced breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced ER-Positive HER2-Negative Breast Cancer
CountriesBelgium, Canada, France, Georgia, Germany, Hungary, Israel, Italy, Poland, Portugal, Russia, South Korea, Spain, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 2Active
20202021202220232024202520262027
First PostedJan 2, 2020
Enrollment StartApr 22, 2020
Primary CompletionAug 30, 2022
Study CompletionJun 16, 2027
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 6.5 years ago

Arms & Interventions

AZD9833 Dose Aexperimental

The patients will receive AZD9833 (Dose A).

Drug: AZD9833
AZD9833 Dose Bexperimental

The patients will receive AZD9833 (Dose B).

Drug: AZD9833
AZD9833 Dose Cexperimental

The patients will receive AZD9833 (Dose C).

Drug: AZD9833
Fulvestrant 500 mgactive_comparator

The patients will receive Fulvestrant (500 mg).

Drug: Fulvestrant

Interventions

AZD9833drug

Dosage formulation: AZD9833 tablets will be administered orally.

Fulvestrantdrug

Dosage formulation: Fulvestrant will be administered via intramuscular (IM) injection.