AZD9833 placebo

DRUG2 trials

Conditions

ER-Positive HER2-Negative Breast Cancer

Phase 3

A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease

Active, not recruitingNCT04711252

AstraZenecaER-Positive HER2-Negative Breast Cancer

Start: 2021-01-28End: 2029-02-01Updated: 2025-10-14

Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)

Active, not recruitingNCT04964934

AstraZenecaER-Positive HER2-Negative Breast Cancer

Start: 2021-06-30End: 2028-09-01Updated: 2026-07-14

2026-07-24

Switching to camizestrant at ESR1 mutation emergence before disease progression during first-line treatment of hormone receptor-positive advanced breast cancer (SERENA-6): extended analysis of a double-blind, placebo-controlled, randomised, phase 3 trial.

2026-07-13

First-line (1L) camizestrant (CAMI) for emergent ESR1 mutations ( ESR1 m) in advanced breast cancer (ABC): Final progression-free survival 2 (PFS2) from the phase III SERENA-6 trial.

Journal of Clinical Oncology2026-06-03

Estimating meaningful change thresholds (MCTs) for selected scales from the European Organisation for Research and Treatment of Cancer (EORTC) questionnaires in the phase 3 SERENA-6 trial in patients with hormone receptor-positive/human epidermal growth factor receptor 2–negative advanced breast cancer (ABC).

JCO Oncology Practice2025-10-01

Abstract P5-06-17: The addition of ribociclib, palbociclib or abemaciclib to the next generation oral SERD, camizestrant, delivers greater anti-tumour efficacy in a range of ESR1wt and ESR1m breast PDX models

Clinical Cancer Research2025-06-13

Abstract PS7-08: Results from SERENA-1 Parts K/L: A Phase 1 study of the next-generation oral selective estrogen receptor degrader (SERD) camizestrant (AZD9833) in combination with ribociclib in women with ER-positive, HER2 negative advanced breast cancer

Clinical Cancer Research2025-06-13

Camizestrant + CDK4/6 inhibitor (CDK4/6i) for the treatment of emergent ESR1 mutations during first-line (1L) endocrine-based therapy (ET) and ahead of disease progression in patients (pts) with HR+/HER2– advanced breast cancer (ABC): Phase 3, double-blind ctDNA-guided SERENA-6 trial.

Journal of Clinical Oncology2025-06-0414 citations

First-Line Camizestrant for Emerging ESR1 -Mutated Advanced Breast Cancer

New England Journal of Medicine2025-06-0165 citations

CAMBRIA-1 & CAMBRIA-2 phase III trials: camizestrant versus standard endocrine therapy in ER+/HER2– early breast cancer

Future Oncology2025-02-274 citations

heredERA Breast Cancer: a phase III, randomized, open-label study evaluating the efficacy and safety of giredestrant plus the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with previously untreated HER2-positive, estrogen receptor-positive locally advanced or metastatic breast cancer

BMC Cancer2024-05-246 citations

2MO Dynamics of ESR1 mutation (ESR1m) circulating tumour DNA (ctDNA) in patients (pts) with estrogen receptor (ER)+ HER2- metastatic breast cancer (mBC) receiving camizestrant or fulvestrant: Exploratory analyses from the SERENA-2 trial

ESMO Open2024-05-013 citations

Clinical activity of camizestrant, a next-generation SERD, versus fulvestrant in patients with a detectable ESR1 mutation: Exploratory analysis of the SERENA-2 phase 2 trial.

Journal of Clinical Oncology2023-06-0119 citations

Design of SERENA-6, a phase III switching trial of camizestrant in ESR1 -mutant breast cancer during first-line treatment

Future Oncology2023-03-0169 citations

Abstract P3-07-28: SERENA-1: Updated analyses from a Phase 1 study of the next generation oral selective estrogen receptor degrader camizestrant (AZD9833) combined with abemaciclib, in women with ER-positive, HER2-negative advanced breast cancer

Cancer Research2023-03-0113 citations

Abstract P3-07-13: The next generation oral selective estrogen receptor degrader (SERD) camizestrant (AZD9833) is active against wild type and mutant estrogen receptor α

Cancer Research2023-03-012 citations

Implementation of CDK4/6 Inhibitors and its Influence on the Treatment Landscape of Advanced Breast Cancer Patients – Data from the Real-World Registry PRAEGNANT

Geburtshilfe und Frauenheilkunde2022-07-1228 citations

Serena-1: Updated analyses from a phase 1 study (parts C/D) of the next-generation oral SERD camizestrant (AZD9833) in combination with palbociclib, in women with ER-positive, HER2-negative advanced breast cancer.

Journal of Clinical Oncology2022-06-0140 citations

Abstract OT2-11-06: SERENA-4: A Phase III comparison of AZD9833 (camizestrant) plus palbociclib, versus anastrozole plus palbociclib, for patients with ER-positive/HER2-negative advanced breast cancer who have not previously received systemic treatment for advanced disease

Cancer Research2022-02-1512 citations

SERENA-4: A phase 3 comparison of AZD9833 (camizestrant) plus palbociclib, versus anastrozole plus palbociclib, for patients with ER-positive, HER2-negative advanced breast cancer who have not previously received systemic treatment for advanced disease.

Journal of Clinical Oncology2021-05-2025 citations

AZD9833 placebo

Sponsors

Conditions

Phase 3

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