SERENA-4: A Randomised, Multicentre, Double-Blind, Phase 3 Study of AZD9833 (an Oral SERD) plus Palbociclib versus Anastrazole plus Palbociclib for the Treatment of Patients with Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503995-26-00

Acronym

D8532C00001

Enrollment

499

Registered

2024-03-13

Start date

2021-05-11

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

Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer

Brief summary

Progression-free survival (PFS) assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST) version 1.1.

Detailed description

"Overall survival (OS) ", Progression-free survival 2 (PFS2), "Objective response rate (ORR) assessed by the Investigator as defined by RECIST version 1.1 ", "Duration of response (DoR) assessed by the Investigator as defined by RECIST version 1.1 ", Time to second subsequent therapy (TSST), Time to chemotherapy (TTC), Time to first subsequent anti-cancer therapy (TFST), Clinical benefit rate at 24 weeks (CBR24), Plasma concentration of AZD9833 at specified timepoints, Change from baseline in EORTC QLQ-C30 and EORTC QLQ-BR45 scales

Interventions

DRUGIBRANCE 125 mg film-coated tablets

DRUGPlacebo to match camizestrant

DRUGIBRANCE 75 mg film-coated tablets

DRUGIBRANCE 125 mg hard capsules

DRUGcamizestrant

DRUGIBRANCE 100 mg hard capsules

DRUGIBRANCE 75 mg hard capsules

DRUGArimidex® 1 mg Filmtabletten

DRUGIBRANCE 100 mg film-coated tablets

DRUGPlacebo to match Arimidex

DRUGLEUPRORELIN ACETATE

DRUGGOSERELIN ACETATE

DRUGCamizestrant

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS) assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST) version 1.1.	—

Secondary

Measure	Time frame
"Overall survival (OS) ", Progression-free survival 2 (PFS2), "Objective response rate (ORR) assessed by the Investigator as defined by RECIST version 1.1 ", "Duration of response (DoR) assessed by the Investigator as defined by RECIST version 1.1 ", Time to second subsequent therapy (TSST), Time to chemotherapy (TTC), Time to first subsequent anti-cancer therapy (TFST), Clinical benefit rate at 24 weeks (CBR24), Plasma concentration of AZD9833 at specified timepoints, Change from baseline in EORTC QLQ-C30 and EORTC QLQ-BR45 scales	—

Measure

Time frame

—

Countries

Austria, Belgium, Bulgaria, Czechia, France, Germany, Hungary, Italy, Norway, Poland, Portugal, Slovakia, Spain

Outcome results

None listed

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